CClinicalTrials.gg
Sign In
CompletedNCT03945825Updated Oct 14, 2025Results posted

Flublok or Fluzone With Advax-CpG55.2 or AF03

A Phase 1 interventional study of AF03 and Delta Inulin-CpG55.2 in Influenza and Influenza Immunisation, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 8 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-14.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
241
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant.

Read the detailed description

This is a Phase I, randomized, double blinded, clinical trial in up to 240 males and non-pregnant females, 18-45 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of either the 2018/2019 seasonal Fluzone or Flublok Quadrivalent Influenza Vaccine (QIV) manufactured by Sanofi Pasteur (SP) given without adjuvant or with one of two adjuvant formulations, AF03 or Advax-CpG55.2. Subjects will be stratified by prior receipt of licensed, seasonal influenza vaccine (defined as receipt of at least one of the 2017/2018 and/or 2018/2019 influenza vaccines) and will be randomly assigned to 1 of 6 treatment arms to receive a single dose of one of the two seasonal 2018/2019 QIV vaccine formulations with or without one of the two adjuvants (Day 1). On approximately Day 90, each subject will receive a single dose of the seasonal 2019/2020 QIV. Groups 1, 2 and 3 will receive 2019/2020 Fluzone QIV and Groups 4, 5 and 6 will receive 2019/2020 Flublok QIV. Eight Vaccine and Treatment Evaluation Unit (VTEU) sites will be included in the study. Study duration is approximately 18 months, and subject participation duration is 12 months. The primary objectives of this study are: 1) to assess the safety and reactogenicity of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 2) to assess the serum hemagglutination inhibition (HAI) antibody responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 3) to assess the serum neuraminidase inhibition antibody (NAI) responses by enzyme-linked lectin assay (ELLA) against NA antigens in the 2018/2019 QIV from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess the influenza neutralizing (Neut) antibody titer responses against 2018/2019 QIV strains from baseline (Day 1) to approximately Day 29 after receipt of 2018/2019 Fluzone and Flublok with and without AF03 or Advax- CpG55.2 adjuvant. The secondary objectives of this study are: 1) to assess protocol specified adverse events of special interest (AESI), medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) that occur after receipt of study product; 2) to assess the HAI, Neut and NAI ELLA responses to the 2019/2020 QIV strains prior to (Day 1) and approximately 28 days after vaccination with the 2019/2020 QIV in all study groups; 3) to assess the HAI antibody responses against heterologous influenza A/H1 and H3 strains from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after receipt of 2018/2019 Fluzone or Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 4) to assess NAI ELLA responses against heterologous N1 and N2 NA antigens from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after administration of 2018/2019 Fluzone with and without AF03 or Advax-CpG55.2 adjuvant; 5) to assess the influenza neutralizing (Neut) antibody titer responses against heterologous influenza A/H1 and H3 strains from baseline (Day 1) to approximately Days 8, 29, 57, 90 and 118 after administration of 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant; 6) to assess the longitudinal kinetics and durability of the HAI, NAI, and Neut responses against the 2018/2019 QIV strains on approximately Days 8, 57, 90 and 118 following receipt of the 2018/2019 Fluzone and Flublok with and without AF03 or Advax-CpG55.2 adjuvant.

02

Conditions studied

  • Influenza
  • Influenza Immunisation

Browse trials for

Keywords

  • Immunogenicity
  • Influenza
  • Influenza Vaccine
  • Phase 1
  • Quadrivalent
  • Safety
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 241 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. Provide written informed consent prior to initiation of any study procedures.
  2. Are able to understand and comply with planned study procedures and be available for all study visits.
  3. Must agree to the collection of venous blood per protocol.
  4. Are males or non-pregnant females, 18 to 45 years of age, inclusive at time of enrollment.
  5. Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria as well as herbals, vitamins and supplements are permitted.
  6. Oral temperature is less than 100.0 degrees Fahrenheit.
  7. Pulse is 47 to 100 beats per minute, inclusive.
  8. Systolic blood pressure is 85 to 140 mmHg, inclusive.
  9. Diastolic blood pressure is 55 to 90 mmHg, inclusive.

  10. Screening laboratories (Erythrocyte Sedimentation Rate (ESR), White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Alkaline Phosphatase (ALP) serum lipase, serum amylase and Creatinine (Cr)) are within acceptable parameters*.

    *ESR must be below 30 mm/hr; WBC >3.90 K/MM3 and \<10.60 K/MM3; Hgb >/= 11.5 g/dl (women) or >/= 12.5 g/dl (men); PLTs (EDTA) 140-415 K/MM3; PLTs (Citrate) 125-325 K/MM3 ALT \</= 43 U/L (women) or \</= 60 U/L (men); T Bili \</=1.20 mg/dl; Cr \< 1.1 mg/dl (women) or \< 1.4 mg/dl (men); AST 10-36 U/L (women) or 10-43 U/L (men); GGT 5--32 U/L (women) or 10-49 U/L (men); ALP 30-115 U/L (women) or 43-115 U/L (men); lipase 13-60 U/L; amylase (Total) 35-121 U/L, for subjects to qualify for randomization and vaccination.

  11. Women of childbearing potential* must use an acceptable contraception method** from at least 30 days before the first study vaccination until 60 days after the second study vaccination.

    *Not sterilized via bilateral oophorectomy, tubal ligation/ salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal.

    • Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, barrier methods such as condoms or diaphragms/cervical cap with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
  12. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination.
  13. For a woman with potential to become pregnant, she understands that in the event of pregnancy during the study she will be approached to enroll in the Sanofi Pregnancy Registry.
  14. Must agree to have residual specimens (i.e. residual/excess of per protocol specifications).

Exclusion Criteria:

  1. Have an acute illness*, as determined by the site Principal Investigator (PI) or appropriate sub-investigator, within 72 hours prior to study vaccination.

    *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.

  2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.

    *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

  3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
  4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  5. Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
  6. Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
  7. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine.
  8. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  9. Have a history of Guillain-Barré Syndrome (GBS).
  10. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  11. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
  12. Have a history of alcohol or drug abuse within 5 years prior to study vaccination.

  13. Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere* with subject compliance or safety evaluations.

    *As determined by the site PI or appropriate sub-investigator.

  14. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
  15. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.

  16. Have taken high-dose inhaled corticosteroids* within 30 days prior to study vaccination.

    *High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.

  17. Received or plan to receive a licensed, live vaccine (excluding all licensed, seasonal LAIVs) within 30 days before or after the study vaccination.
  18. Received or plan to receive a licensed, inactivated vaccine (excluding all licensed, seasonal IIVs) within 14 days before or after each study vaccination.
  19. Have received any 2018/2019 seasonal influenza vaccine within the 6 months prior to enrollment.
  20. Plans to receive any 2019/2020 seasonal influenza vaccine within approximately 90 days of receipt of the first study vaccination.
  21. Have a known history of documented influenza infection within the past 6 months.
  22. Received immunoglobulin or other blood products (except Rho D immunoglobulin) within 90 days prior to study vaccination.

  23. Received an experimental agent* within 30 days prior to the study vaccination or expect to receive another experimental agent* during the trial-reporting period*.

    *Including vaccine, drug, biologic, device, blood product, or medication.

    **Other than from participation in this trial.

    ***Approximately 12 months after the first study vaccination.

  24. Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the trial-reporting period**.

    *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.

    **Approximately 12 months after the first study vaccination.

  25. Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
  26. Plan to travel outside the US (continental US, Hawaii and Alaska) from the time of study vaccination through approximately 90 days after the first study vaccination.
  27. Planning to donate blood within 4 months following first vaccination.

Exclusion Criteria for Second Study Vaccination:

All study participants will be expected to receive the second study vaccination except under the circumstances listed below. The second study vaccination will not be administered to a subject if any of the following criteria are met:

  • Meets the contraindication on the package insert to receipt of licensed influenza vaccine.
  • As deemed necessary by the site principal investigator or appropriate sub-investigator for noncompliance or other reasons.
  • Subject refusal of further study vaccination.
  • Withdrawal of consent.
  • Subject is lost to follow-up.
  • Termination of this trial.
  • New information becomes available that makes further participation unsafe.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    Group 1

    0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40

    Biological: Influenza Virus Quadrivalent Inactivated Vaccine

  • Experimental
    Group 2

    0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90, n=40

    Drug: AF03 · Biological: Influenza Virus Quadrivalent Inactivated Vaccine

  • Experimental
    Group 3

    0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90, n=40

    Biological: Delta Inulin-CpG55.2 · Biological: Influenza Virus Quadrivalent Inactivated Vaccine

  • Experimental
    Group 4

    0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40

    Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine

  • Experimental
    Group 5

    0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40

    Drug: AF03 · Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine

  • Experimental
    Group 6

    0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90, n=40

    Biological: Delta Inulin-CpG55.2 · Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine

Interventions

  • DrugAF03

    A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether

  • BiologicalDelta Inulin-CpG55.2

    A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)

  • BiologicalInfluenza Virus Quadrivalent Inactivated Vaccine

    2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval

  • BiologicalQuadrivalent Recombinant Seasonal Influenza Vaccine

    2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination

    Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.

    Time frame: Day 1 through Day 8

  2. Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29

    Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 28 days after the first study vaccination while serious adverse events (SAEs) were collected at follow up visits through approximately 12 months after the first study vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).

    Time frame: Day 1 through Day 29

  3. Number of Participants Reporting Serious Adverse Events (SAEs)

    SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 12 months after the first study vaccination.

    Time frame: Day 1 through Day 365

  4. Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination

    Laboratory parameters include white blood cells (WBC), hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), alkaline phosphatase (ALP), amylase, lipase, and creatinine. Thresholds for adverse events were considered WBC of 3.90 x10\^3/uL or lower or 10.60 x10\^3/uL or higher; hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/uL or below or 416 x10\^3/uL or greater when using EDTA tubes or platelets 124 x10\^3/uL or below or 550 x10\^3/uL or greater when using Citrate tubes; ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); AST 37 IU/L or greater (female) or 44 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; GGT 33 IU/L or greater (female) or 50 IU/L or greater (male); ALP 116 IU/L or greater; amylase 122 IU/L or greater; lipase 61 IU/L or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male).

    Time frame: Day 1 through Day 8

  5. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Time frame: Day 1, Day 29

  6. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 29

  7. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 29

  8. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Time frame: Day 1, Day 29

  9. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 29

  10. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Time frame: Day 1, Day 29

  11. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 29

  12. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 29.

    Time frame: Day 29

  13. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 29

  14. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

    Time frame: Day 1, Day 29

  15. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 29

  16. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 29

  17. Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab.

    Time frame: Day 1, Day 29

  18. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 29

Secondary outcomes

  1. Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)

    Participants were queried at each visit for the occurrence of adverse events of special interest (AESIs) through approximately 12 months following the first study vaccination. AESIs include reports of tearing, dry mouth, and dry eyes.

    Time frame: Day 1 through Day 365

  2. Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)

    Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) through approximately 12 months following the first study vaccination.

    Time frame: Day 1 through Day 365

  3. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Time frame: Day 90 through Day 118

  4. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 90 through Day 118

  5. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post- second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 118

  6. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Time frame: Day 90 through Day 118

  7. Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 90 through Day 118

  8. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Time frame: Day 90 through Day 118

  9. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 90 through Day 118

  10. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 90 through Day 118.

    Time frame: Day 118

  11. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 118

  12. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

    Time frame: Day 90 through Day 118

  13. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 90 through Day 118

  14. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post-second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 118

  15. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 118

  16. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Time frame: Day 8, Day 57, Day 90, Day 118

  17. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 8, Day 57, Day 90, Day 118

  18. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 8, Day 57, Day 90, Day 118

  19. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Time frame: Day 8, Day 57, Day 90, Day 118

  20. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 57, Day 90, Day 118

  21. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Time frame: Day 8, Day 57, Day 90, Day 118

  22. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 8, Day 57, Day 90, Day 118

  23. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 57, 90, and 118.

    Time frame: Day 8, Day 57, Day 90, Day 118

  24. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 57, Day 90, Day 118

  25. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

    Time frame: Day 8, Day 57, Day 90, Day 118

  26. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 8, Day 57, Day 90, Day 118

  27. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 8, Day 57, Day 90, Day 118

  28. Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab.

    Time frame: Day 8, Day 57, Day 90, Day 118

  29. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

    Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 57, Day 90, Day 118

  30. Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  31. Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms was calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  32. Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

  33. Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  34. Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

  35. Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  36. Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  37. Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 29, 57, 90, and 118.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

  38. Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

    Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

  39. Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  40. Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

    Time frame: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118

  41. Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

  42. Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

    Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

    Time frame: Day 8, Day 29, Day 57, Day 90, Day 118

07

Results

Posted Jan 3, 2022

Participant flow

Participants were healthy males and non-pregnant females aged 18 to 45 years old recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 18JUN2019 and 27AUG2019.

Participant flow — Overall Study
MilestoneFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Started413740413943
Completed393239393640
Not completed251233
Withdrew: Enrolled but treatment not administered000010
Withdrew: Lost to follow-up150122
Withdrew: Withdrawal by subject101101

Outcome measures

PrimaryNumber of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination

Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.

Time frame:
Day 1 through Day 8
Reported as:
Count of participants · Participants
Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Any Systemic Symptom242523231826
Any Local Symptom353640323343
PrimaryNumber of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29

Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 28 days after the first study vaccination while serious adverse events (SAEs) were collected at follow up visits through approximately 12 months after the first study vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).

Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
AEs12118141015
SAEs000000
PrimaryNumber of Participants Reporting Serious Adverse Events (SAEs)

SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 12 months after the first study vaccination.

Time frame:
Day 1 through Day 365
Reported as:
Count of participants · Participants
Number of Participants Reporting Serious Adverse Events (SAEs)
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Number of Participants Reporting Serious Adverse Events (SAEs)010001
PrimaryNumber of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination

Laboratory parameters include white blood cells (WBC), hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), alkaline phosphatase (ALP), amylase, lipase, and creatinine. Thresholds for adverse events were considered WBC of 3.90 x10\^3/uL or lower or 10.60 x10\^3/uL or higher; hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/uL or below or 416 x10\^3/uL or greater when using EDTA tubes or platelets 124 x10\^3/uL or below or 550 x10\^3/uL or greater when using Citrate tubes; ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); AST 37 IU/L or greater (female) or 44 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; GGT 33 IU/L or greater (female) or 50 IU/L or greater (male); ALP 116 IU/L or greater; amylase 122 IU/L or greater; lipase 61 IU/L or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male).

Time frame:
Day 1 through Day 8
Reported as:
Count of participants · Participants
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
WBCs623230
Hemoglobin112300
Platelets000400
ALT110111
AST010121
Bilirubin001010
GGT200002
ALP000011
Amylase101000
Lipase011000
Creatinine100001
PrimaryGeometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

Time frame:
Day 1, Day 29
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1114.1 (72.7 to 179.1)193.0 (129.8 to 286.8)96.8 (60.4 to 155.0)164.1 (106.4 to 253.0)129.7 (81.1 to 207.5)108.6 (74.2 to 158.9)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1140.9 (88.5 to 224.6)149.8 (101.2 to 221.9)120.2 (75.7 to 190.8)248.3 (156.0 to 395.2)107.1 (70.4 to 162.9)131.3 (90.6 to 190.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 1242.1 (164.8 to 355.7)196.6 (139.2 to 277.6)174.5 (108.2 to 281.2)296.6 (194.9 to 451.3)186.8 (117.1 to 298.2)237.8 (156.9 to 360.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1366.3 (262.9 to 510.4)478.7 (311.3 to 736.1)489.3 (355.3 to 673.7)618.7 (397.9 to 962.2)331.9 (208.7 to 527.8)390.1 (296.2 to 513.7)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29270.2 (195.9 to 372.8)538.2 (414.7 to 698.5)340.5 (257.1 to 451.0)634.5 (478.4 to 841.4)516.0 (357.5 to 744.6)492.5 (359.4 to 674.8)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29423.0 (323.1 to 553.7)456.9 (338.5 to 616.7)349.7 (253.3 to 482.9)515.4 (355.0 to 748.3)416.0 (281.3 to 615.2)388.7 (278.7 to 542.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 29488.3 (363.2 to 656.6)474.9 (354.3 to 636.4)365.6 (259.8 to 514.5)680.0 (479.4 to 964.5)722.9 (516.0 to 1012.7)522.5 (371.6 to 734.6)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29952.2 (721.6 to 1256.5)1356.1 (1006.0 to 1828.1)1081.1 (828.3 to 1411.2)1645.6 (1252.9 to 2161.4)1280.0 (969.6 to 1689.8)1280.0 (995.0 to 1646.6)
PrimaryRatio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 29
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11.7 (0.9 to 3.1)0.8 (0.4 to 1.6)0.8 (0.4 to 1.5)0.7 (0.4 to 1.2)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 11.1 (0.6 to 1.9)0.9 (0.4 to 1.6)0.4 (0.2 to 0.8)0.5 (0.3 to 0.9)
A/Michigan/45/2015 X-275 (H1N1) - Day 10.8 (0.5 to 1.4)0.7 (0.4 to 1.3)0.6 (0.3 to 1.2)0.8 (0.4 to 1.4)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11.3 (0.8 to 2.2)1.3 (0.8 to 2.1)0.5 (0.3 to 1.0)0.6 (0.4 to 1.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 292.0 (1.3 to 3.0)1.3 (0.8 to 1.9)0.8 (0.5 to 1.3)0.8 (0.5 to 1.2)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 291.1 (0.7 to 1.6)0.8 (0.5 to 1.3)0.8 (0.5 to 1.4)0.8 (0.5 to 1.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 291.0 (0.6 to 1.5)0.7 (0.5 to 1.2)1.1 (0.7 to 1.7)0.8 (0.5 to 1.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 291.4 (1.0 to 2.1)1.1 (0.8 to 1.7)0.8 (0.5 to 1.1)0.8 (0.5 to 1.1)
PrimaryPercentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 29
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)27 (14 to 43)33 (19 to 51)36 (21 to 53)45 (29 to 62)46 (29 to 63)56 (40 to 72)
B/Maryland/15/2016 BX-69A (B Victoria lineage)29 (16 to 46)36 (21 to 54)31 (17 to 48)23 (11 to 38)41 (25 to 58)32 (18 to 48)
A/Michigan/45/2015 X-275 (H1N1)24 (12 to 40)19 (8 to 36)18 (8 to 34)23 (11 to 38)46 (29 to 63)32 (18 to 48)
B/Phuket/3073/2013 (B Yamagata lineage)24 (12 to 40)25 (12 to 42)23 (11 to 39)28 (15 to 44)30 (16 to 47)34 (20 to 51)
PrimaryPercentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

Time frame:
Day 1, Day 29
Reported as:
Number · percentage of participants
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 185 (71 to 94)95 (82 to NA)75 (59 to 87)93 (80 to 98)76 (60 to 89)88 (74 to 96)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 180 (65 to 91)89 (75 to 97)80 (64 to 91)90 (77 to 97)79 (63 to 90)90 (77 to 97)
A/Michigan/45/2015 X-275 (H1N1) - Day 193 (80 to 98)95 (82 to NA)88 (73 to 96)93 (80 to 98)89 (75 to 97)95 (84 to NA)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 198 (87 to NA)95 (82 to NA)100 (91 to 100)95 (83 to NA)92 (79 to 98)100 (92 to 100)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29100 (91 to 100)100 (90 to 100)97 (87 to NA)100 (91 to 100)97 (86 to NA)100 (91 to 100)
A/Michigan/45/2015 X-275 (H1N1) - Day 29100 (91 to 100)100 (90 to 100)97 (87 to NA)98 (87 to NA)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
PrimaryGeometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 29
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)2.4 (1.6 to 3.6)2.6 (1.8 to 3.7)3.6 (2.4 to 5.5)3.8 (2.5 to 5.7)3.8 (2.7 to 5.3)4.3 (2.9 to 6.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage)3.0 (2.0 to 4.5)3.2 (2.1 to 4.8)2.9 (2.0 to 4.4)2.1 (1.5 to 2.7)3.7 (2.5 to 5.4)2.9 (2.1 to 4.0)
A/Michigan/45/2015 X-275 (H1N1)2.0 (1.4 to 3.0)2.3 (1.5 to 3.5)2.2 (1.5 to 3.2)2.1 (1.7 to 2.8)3.7 (2.4 to 5.8)2.1 (1.5 to 3.0)
B/Phuket/3073/2013 (B Yamagata lineage)2.6 (1.9 to 3.6)2.7 (1.8 to 4.0)2.3 (1.7 to 3.0)2.6 (1.9 to 3.7)4.0 (2.6 to 6.0)3.2 (2.4 to 4.2)
PrimaryGeometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

Time frame:
Day 1, Day 29
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1123.1 (85.1 to 178.1)116.4 (82.3 to 164.5)91.9 (60.3 to 140.1)140.9 (91.1 to 218.0)129.7 (92.5 to 181.8)105.9 (73.8 to 152.0)
B/Colorado/06/2017 (B Victoria lineage) - Day 1178.6 (142.4 to 223.9)211.9 (156.5 to 286.9)213.0 (160.3 to 282.9)256.9 (183.1 to 360.4)226.3 (170.3 to 300.6)166.7 (131.3 to 211.7)
A/Michigan/45/2015 X-275 (H1N1) - Day 1118.0 (81.6 to 170.6)108.0 (75.4 to 154.7)96.8 (63.7 to 147.0)143.3 (92.8 to 221.5)127.4 (89.8 to 180.7)100.8 (69.2 to 146.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 163.1 (49.9 to 79.9)89.5 (69.6 to 115.1)91.1 (72.5 to 114.5)88.5 (65.8 to 119.1)81.5 (62.8 to 105.7)66.7 (54.0 to 82.5)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29259.0 (197.1 to 340.5)293.4 (213.9 to 402.6)224.3 (164.5 to 305.7)157.3 (105.7 to 234.0)129.0 (94.0 to 177.1)107.5 (74.7 to 154.8)
B/Colorado/06/2017 (B Victoria lineage) - Day 29402.0 (333.4 to 484.8)538.2 (409.8 to 706.8)464.8 (367.3 to 588.1)346.0 (258.6 to 462.8)243.9 (186.7 to 318.5)211.5 (167.6 to 266.8)
A/Michigan/45/2015 X-275 (H1N1) - Day 29250.4 (191.5 to 327.5)264.0 (195.8 to 355.8)216.4 (160.6 to 291.7)161.4 (111.1 to 234.5)129.0 (95.7 to 173.9)105.7 (73.0 to 153.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29116.0 (98.2 to 137.1)188.5 (147.0 to 241.6)143.8 (117.2 to 176.5)112.2 (87.8 to 143.3)92.1 (72.7 to 116.6)82.1 (66.9 to 100.6)
PrimaryRatio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 29
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 10.9 (0.6 to 1.6)0.7 (0.4 to 1.3)0.9 (0.5 to 1.6)0.8 (0.4 to 1.3)
B/Colorado/06/2017 (B Victoria lineage) - Day 11.2 (0.8 to 1.7)1.2 (0.8 to 1.7)0.9 (0.6 to 1.4)0.6 (0.4 to 1.0)
A/Michigan/45/2015 X-275 (H1N1) - Day 10.9 (0.6 to 1.5)0.8 (0.5 to 1.4)0.9 (0.5 to 1.5)0.7 (0.4 to 1.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11.4 (1.0 to 2.0)1.4 (1.0 to 2.0)0.9 (0.6 to 1.4)0.8 (0.5 to 1.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 291.1 (0.8 to 1.7)0.9 (0.6 to 1.3)0.8 (0.5 to 1.4)0.7 (0.4 to 1.2)
B/Colorado/06/2017 (B Victoria lineage) - Day 291.3 (1.0 to 1.9)1.2 (0.9 to 1.6)0.7 (0.5 to 1.0)0.6 (0.4 to 0.9)
A/Michigan/45/2015 X-275 (H1N1) - Day 291.1 (0.7 to 1.6)0.9 (0.6 to 1.3)0.8 (0.5 to 1.3)0.7 (0.4 to 1.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 291.6 (1.2 to 2.2)1.2 (1.0 to 1.6)0.8 (0.6 to 1.1)0.7 (0.5 to 1.0)
PrimaryPercentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 29.

Time frame:
Day 29
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)27 (14 to 43)36 (21 to 54)36 (21 to 53)3 (NA to 13)0 (0 to 9)2 (NA to 13)
B/Colorado/06/2017 (B Victoria lineage)27 (14 to 43)25 (12 to 42)18 (8 to 34)0 (0 to 9)0 (0 to 9)5 (NA to 17)
A/Michigan/45/2015 X-275 (H1N1)27 (14 to 43)31 (16 to 48)36 (21 to 53)3 (NA to 13)0 (0 to 9)2 (NA to 13)
B/Phuket/3073/2013 (B Yamagata lineage)20 (9 to 35)22 (10 to 39)10 (3 to 24)3 (NA to 13)0 (0 to 9)2 (NA to 13)
PrimaryGeometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 29
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)2.1 (1.6 to 2.7)2.5 (2.0 to 3.3)2.6 (2.0 to 3.2)1.0 (0.9 to 1.2)1.0 (0.9 to 1.1)1.0 (0.9 to 1.3)
B/Colorado/06/2017 (B Victoria lineage)2.3 (1.9 to 2.7)2.6 (2.0 to 3.3)2.2 (1.8 to 2.7)1.2 (1.1 to 1.4)1.1 (1.0 to 1.2)1.2 (1.0 to 1.5)
A/Michigan/45/2015 X-275 (H1N1)2.1 (1.7 to 2.7)2.5 (1.9 to 3.2)2.4 (1.9 to 3.0)1.0 (0.9 to 1.2)1.0 (0.9 to 1.2)1.1 (0.9 to 1.3)
B/Phuket/3073/2013 (B Yamagata lineage1.8 (1.5 to 2.3)2.1 (1.7 to 2.6)1.6 (1.3 to 2.0)1.2 (1.0 to 1.3)1.2 (1.0 to 1.3)1.2 (1.0 to 1.4)
PrimaryGeometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.

Time frame:
Day 1, Day 29
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1106.8 (78.0 to 146.1)147.7 (111.1 to 196.3)101.9 (75.5 to 137.6)151.6 (109.9 to 209.2)121.2 (87.6 to 167.7)118.5 (88.4 to 158.8)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1108.9 (63.1 to 187.9)113.4 (68.8 to 186.9)94.0 (53.9 to 164.0)199.4 (115.0 to 345.9)81.9 (49.7 to 134.9)101.0 (65.3 to 156.4)
A/Michigan/45/2015 X-275 (H1N1) - Day 13141.7 (2145.9 to 4599.4)2697.5 (1756.2 to 4143.2)2147.8 (1271.7 to 3627.5)3703.3 (2937.7 to 5719.6)2214.0 (1337.5 to 3664.9)2764.2 (1667.7 to 4581.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1479.4 (320.1 to 717.9)577.8 (383.2 to 871.1)630.3 (447.0 to 889.0)860.1 (562.1 to 1316.1)447.8 (281.3 to 712.9)539.2 (394.8 to 736.5)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29379.1 (285.4 to 503.4)671.9 (497.1 to 908.2)456.5 (334.5 to 622.9)848.9 (667.6 to 1079.4)741.9 (536.1 to 1026.7)567.0 (422.5 to 760.9)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29302.2 (207.7 to 439.8)305.1 (219.1 to 424.9)248.4 (169.4 to 364.3)463.3 (279.2 to 768.9)304.8 (188.2 to 493.7)291.6 (191.2 to 444.7)
A/Michigan/45/2015 X-275 (H1N1) - Day 295639.5 (3958.0 to 8035.2)5435.2 (3627.9 to 8142.8)4455.8 (2877.2 to 6900.5)8539.5 (5785.7 to 12603.9)9197.6 (5941.1 to 14239.1)6021.9 (4138.3 to 8762.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 291162.7 (860.0 to 1572.0)1437.4 (1053.1 to 1962.0)1152.1 (873.2 to 1520.1)2053.5 (1509.7 to 2793.3)1473.1 (1049.7 to 2067.5)1291.7 (940.6 to 1774.0)
PrimaryRatio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 29
Reported as:
Number · ratio of GMT
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11.4 (0.9 to 2.1)1.0 (0.6 to 1.5)0.8 (0.5 to 1.3)0.8 (0.5 to 1.2)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 11.0 (0.5 to 2.2)0.9 (0.4 to 1.9)0.4 (0.2 to 0.9)0.5 (0.3 to 1.0)
A/Michigan/45/2015 X-275 (H1N1) - Day 10.9 (0.5 to 1.5)0.7 (0.4 to 1.3)0.6 (0.3 to 1.2)0.7 (0.4 to 1.4)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11.2 (0.7 to 2.1)1.3 (0.8 to 2.2)0.5 (0.3 to 1.0)0.6 (0.4 to 1.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 291.8 (1.2 to 2.7)1.2 (0.8 to 1.8)0.9 (0.6 to 1.3)0.7 (0.5 to 1.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 291.0 (0.6 to 1.7)0.8 (0.5 to 1.4)0.7 (0.3 to 1.3)0.6 (0.3 to 1.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 291.0 (0.6 to 1.6)0.8 (0.5 to 1.4)1.1 (0.6 to 1.9)0.7 (0.4 to 1.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 291.2 (0.8 to 1.9)1.0 (0.7 to 1.5)0.7 (0.5 to 1.1)0.6 (0.4 to 1.0)
PrimaryPercentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 29
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)37 (22 to 53)42 (26 to 59)38 (23 to 55)60 (43 to 75)65 (47 to 80)56 (40 to 72)
B/Maryland/15/2016 BX-69A (B Victoria lineage)22 (11 to 38)19 (8 to 36)28 (15 to 45)20 (9 to 36)30 (16 to 47)34 (20 to 51)
A/Michigan/45/2015 X-275 (H1N1)15 (6 to 29)11 (3 to 26)21 (9 to 36)20 (9 to 36)41 (25 to 58)20 (9 to 35)
B/Phuket/3073/2013 (B Yamagata lineage)24 (12 to 40)14 (5 to 29)18 (8 to 34)18 (7 to 33)30 (16 to 47)22 (11 to 38)
PrimaryPercentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab.

Time frame:
Day 1, Day 29
Reported as:
Number · percentage of participants
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 188 (74 to 96)95 (82 to NA)75 (59 to 87)90 (77 to 97)89 (75 to 97)90 (77 to 97)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 178 (62 to 89)78 (62 to 90)68 (51 to 81)83 (68 to 93)71 (54 to 85)76 (61 to 88)
A/Michigan/45/2015 X-275 (H1N1) - Day 1100 (91 to 100)97 (86 to NA)98 (87 to NA)100 (91 to 100)97 (86 to NA)98 (87 to NA)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1100 (91 to 100)97 (86 to NA)100 (91 to 100)95 (83 to NA)92 (79 to 98)100 (92 to 100)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 2995 (83 to NA)97 (85 to NA)95 (83 to NA)90 (76 to 97)92 (78 to 98)95 (83 to NA)
A/Michigan/45/2015 X-275 (H1N1) - Day 29100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
PrimaryGeometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 29
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)3.6 (2.7 to 4.7)4.3 (3.1 to 6.1)4.6 (3.2 to 6.7)5.5 (3.9 to 7.7)5.9 (4.6 to 7.5)4.6 (3.4 to 6.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage)2.8 (1.7 to 4.5)2.8 (1.6 to 4.8)2.7 (1.6 to 4.3)2.3 (1.6 to 3.3)3.5 (2.4 to 5.3)2.8 (1.9 to 4.2)
A/Michigan/45/2015 X-275 (H1N1)1.8 (1.1 to 2.8)1.9 (1.1 to 3.3)2.2 (1.3 to 3.6)2.1 (1.6 to 2.8)4.2 (2.4 to 7.2)2.1 (1.4 to 3.2)
B/Phuket/3073/2013 (B Yamagata lineage)2.4 (1.6 to 3.6)2.4 (1.6 to 3.6)1.9 (1.4 to 2.6)2.4 (1.7 to 3.4)3.4 (2.0 to 5.5)2.3 (1.7 to 3.3)
SecondaryNumber of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)

Participants were queried at each visit for the occurrence of adverse events of special interest (AESIs) through approximately 12 months following the first study vaccination. AESIs include reports of tearing, dry mouth, and dry eyes.

Time frame:
Day 1 through Day 365
Reported as:
Count of participants · Participants
Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)000000
SecondaryNumber of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)

Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) through approximately 12 months following the first study vaccination.

Time frame:
Day 1 through Day 365
Reported as:
Count of participants · Participants
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
ParticipantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
MAAEs91378710
NOCMCs100110
PIMMCs000000
SecondaryGeometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

Time frame:
Day 90 through Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90325.5 (242.9 to 436.0)326.2 (237.6 to 447.9)234.7 (157.8 to 349.1)456.6 (314.7 to 662.4)408.2 (278.0 to 599.4)355.1 (246.5 to 511.4)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118387.9 (281.0 to 535.6)367.6 (254.7 to 530.6)269.1 (173.3 to 417.7)627.1 (430.9 to 912.7)509.8 (330.5 to 786.5)491.0 (343.5 to 701.9)
A/Kansas/14/2017 (H3N2) - Day 9033.8 (23.2 to 49.2)67.9 (44.6 to 103.4)38.2 (25.8 to 56.6)69.4 (47.0 to 102.4)50.1 (32.5 to 77.2)62.2 (41.8 to 92.5)
A/Kansas/14/2017 (H3N2) - Day 118203.5 (132.1 to 313.6)213.6 (136.9 to 333.1)274.6 (198.4 to 380.1)369.1 (238.5 to 571.2)254.9 (154.2 to 421.3)212.8 (135.9 to 333.5)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90797.3 (595.9 to 1066.9)1129.4 (853.2 to 1495.2)849.1 (644.1 to 1119.4)1502.0 (1132.8 to 1991.7)1041.6 (747.5 to 1451.6)995.6 (752.0 to 1318.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118665.1 (499.2 to 886.2)874.3 (647.1 to 1181.1)792.8 (615.8 to 1020.6)1228.9 (924.0 to 1634.4)905.1 (649.8 to 1260.7)1065.4 (836.2 to 1357.5)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90312.0 (231.6 to 420.3)339.0 (241.2 to 476.5)245.6 (170.6 to 353.7)410.4 (270.4 to 622.8)323.0 (219.2 to 475.9)303.8 (215.8 to 427.6)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118323.1 (235.1 to 443.9)281.8 (196.2 to 404.8)255.7 (170.6 to 383.3)404.5 (255.1 to 641.4)320.0 (224.4 to 456.3)329.9 (233.6 to 465.9)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 90 through Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 901.0 (0.7 to 1.5)0.7 (0.4 to 1.2)0.9 (0.5 to 1.5)0.8 (0.5 to 1.3)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 1180.9 (0.6 to 1.5)0.7 (0.4 to 1.2)0.8 (0.5 to 1.4)0.8 (0.5 to 1.3)
A/Kansas/14/2017 (H3N2) - Day 902.0 (1.2 to 3.5)1.1 (0.7 to 1.9)0.7 (0.4 to 1.3)0.9 (0.5 to 1.5)
A/Kansas/14/2017 (H3N2) - Day 1181.0 (0.6 to 1.9)1.3 (0.8 to 2.3)0.7 (0.4 to 1.3)0.6 (0.3 to 1.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.4 (1.0 to 2.1)1.1 (0.7 to 1.6)0.7 (0.5 to 1.1)0.7 (0.4 to 1.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.3 (0.9 to 2.0)1.2 (0.8 to 1.7)0.7 (0.5 to 1.1)0.9 (0.6 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 901.1 (0.7 to 1.7)0.8 (0.5 to 1.3)0.8 (0.4 to 1.4)0.7 (0.4 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1180.9 (0.5 to 1.4)0.8 (0.5 to 1.3)0.8 (0.4 to 1.4)0.8 (0.5 to 1.4)
SecondaryPercentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post- second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)0 (0 to 10)0 (0 to 12)0 (0 to 10)6 (NA to 20)0 (0 to 11)6 (NA to 20)
A/Kansas/14/2017 (H3N2)67 (49 to 81)43 (25 to 63)74 (56 to 87)56 (38 to 73)53 (35 to 71)53 (35 to 70)
B/Phuket/3073/2013 (B Yamagata lineage)0 (0 to 10)0 (0 to 12)0 (0 to 10)0 (0 to 10)0 (0 to 11)0 (0 to 10)
B/Maryland/15/2016 BX-69A (B Victoria lineage)0 (0 to 10)0 (0 to 12)0 (0 to 10)0 (0 to 10)0 (0 to 11)0 (0 to 10)
SecondaryPercentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

Time frame:
Day 90 through Day 118
Reported as:
Number · percentage of participants
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90100 (91 to 100)100 (90 to 100)92 (79 to 98)95 (83 to NA)95 (82 to NA)95 (83 to NA)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118100 (90 to 100)100 (88 to 100)91 (76 to 98)97 (85 to NA)97 (84 to NA)97 (85 to NA)
A/Kansas/14/2017 (H3N2) - Day 9041 (26 to 58)67 (49 to 81)50 (33 to 67)77 (61 to 89)59 (42 to 75)73 (56 to 85)
A/Kansas/14/2017 (H3N2) - Day 11892 (78 to 98)93 (78 to NA)94 (80 to NA)100 (90 to 100)91 (75 to 98)94 (80 to NA)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118100 (90 to 100)100 (88 to 100)100 (90 to 100)100 (90 to 100)100 (89 to 100)100 (90 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 9098 (87 to NA)100 (90 to 100)97 (86 to NA)97 (87 to NA)97 (86 to NA)100 (91 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118100 (90 to 100)100 (88 to 100)97 (85 to NA)100 (90 to 100)94 (79 to NA)100 (90 to 100)
SecondaryGeometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 90 through Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)1.1 (1.0 to 1.2)1.1 (1.0 to 1.2)1.2 (1.1 to 1.4)1.3 (1.1 to 1.6)1.3 (1.1 to 1.4)1.4 (1.2 to 1.7)
A/Kansas/14/2017 (H3N2)7.1 (4.8 to 10.6)3.3 (2.3 to 4.6)6.9 (4.7 to 10.0)5.4 (3.4 to 8.4)5.5 (3.4 to 8.7)3.6 (2.7 to 4.9)
B/Phuket/3073/2013 (B Yamagata lineage)0.8 (0.8 to 0.9)0.8 (0.7 to 0.9)1.0 (0.8 to 1.1)0.8 (0.7 to 1.0)0.9 (0.8 to 1.0)1.1 (0.9 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage)1.1 (0.9 to 1.2)0.9 (0.8 to 1.0)1.0 (0.9 to 1.2)1.0 (0.9 to 1.1)1.0 (0.9 to 1.2)1.1 (1.0 to 1.3)
SecondaryGeometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

Time frame:
Day 90 through Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
titerFluzoneFluzone + AF03Fluzone + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 9090.1 (65.0 to 124.8)91.5 (65.8 to 127.3)72.4 (50.1 to 104.5)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118107.8 (76.8 to 151.3)111.8 (79.4 to 157.5)79.2 (55.6 to 112.7)
A/Kansas/14/2017 (H3N2) - Day 9035.8 (28.9 to 44.5)49.0 (38.6 to 62.1)36.5 (28.1 to 47.5)
A/Kansas/14/2017 (H3N2) - Day 11848.5 (38.2 to 61.6)51.0 (41.0 to 63.4)45.7 (34.8 to 59.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90104.0 (86.2 to 125.4)156.9 (120.1 to 205.0)137.0 (113.1 to 166.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118115.3 (97.5 to 136.4)158.2 (117.3 to 213.3)150.5 (120.1 to 188.6)
B/Colorado/06/2017 (B Victoria lineage) - Day 90286.7 (241.4 to 340.5)391.7 (285.8 to 536.8)294.8 (234.2 to 371.0)
B/Colorado/06/2017 (B Victoria lineage) - Day 118373.3 (305.9 to 455.5)474.0 (351.9 to 638.3)400.4 (313.3 to 511.8)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 90 through Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 901.0 (0.6 to 1.6)0.8 (0.5 to 1.3)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 1181.0 (0.6 to 1.7)0.7 (0.5 to 1.2)
A/Kansas/14/2017 (H3N2) - Day 901.4 (1.0 to 1.9)1.0 (0.7 to 1.4)
A/Kansas/14/2017 (H3N2) - Day 1181.1 (0.8 to 1.4)0.9 (0.7 to 1.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.5 (1.1 to 2.1)1.3 (1.0 to 1.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.4 (1.0 to 1.9)1.3 (1.0 to 1.7)
B/Colorado/06/2017 (B Victoria lineage) - Day 901.4 (1.0 to 1.9)1.0 (0.8 to 1.4)
B/Colorado/06/2017 (B Victoria lineage) - Day 1181.3 (0.9 to 1.8)1.1 (0.8 to 1.5)
SecondaryPercentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 90 through Day 118.

Time frame:
Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)6 (NA to 19)0 (0 to 12)0 (0 to 10)
A/Kansas/14/2017 (H3N2)8 (2 to 22)0 (0 to 12)0 (0 to 10)
B/Phuket/3073/2013 (B Yamagata lineage)3 (NA to 15)0 (0 to 12)0 (0 to 10)
B/Colorado/06/2017 (B Victoria lineage)8 (2 to 22)0 (0 to 12)0 (0 to 10)
SecondaryGeometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 118
Reported as:
Geometric mean · Fold Rise
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
Fold RiseFluzoneFluzone + AF03Fluzone + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)1.3 (1.1 to 1.5)1.2 (1.0 to 1.3)1.2 (1.1 to 1.4)
A/Kansas/14/2017 (H3N2)1.4 (1.2 to 1.7)1.1 (1.0 to 1.2)1.3 (1.1 to 1.5)
B/Phuket/3073/2013 (B Yamagata lineage)1.2 (1.0 to 1.3)1.0 (0.9 to 1.2)1.1 (1.0 to 1.2)
B/Colorado/06/2017 (B Victoria lineage)1.3 (1.2 to 1.6)1.3 (1.2 to 1.5)1.3 (1.2 to 1.5)
SecondaryGeometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.

Time frame:
Day 90 through Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 903375.3 (2416.0 to 4715.5)3727.3 (2736.7 to 5076.5)2488.0 (1582.9 to 3910.7)4850.2 (3042.7 to 7731.4)5622.8 (3362.1 to 9403.6)3899.5 (2623.1 to 5796.9)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 1183891.7 (2737.9 to 5531.8)3613.3 (2494.4 to 5234.0)2895.1 (1881.9 to 4453.8)6618.8 (4313.1 to 10157.2)5654.7 (3513.2 to 9101.6)4983.6 (3408.9 to 7285.6)
A/Kansas/14/2017 (H3N2) - Day 9050.7 (41.0 to 62.5)81.4 (63.0 to 105.3)57.2 (45.0 to 72.7)90.7 (65.0 to 126.7)72.3 (56.8 to 92.2)79.1 (60.9 to 102.8)
A/Kansas/14/2017 (H3N2) - Day 118238.1 (164.2 to 345.2)198.0 (140.0 to 280.2)225.6 (173.2 to 293.9)396.6 (262.7 to 598.7)266.5 (178.4 to 398.2)251.9 (168.1 to 377.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90681.0 (490.3 to 945.9)909.3 (638.8 to 1294.5)766.9 (541.3 to 1086.4)1371.5 (981.9 to 1915.7)953.5 (638.6 to 1423.7)754.8 (533.9 to 1066.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181087.2 (762.1 to 1551.2)1031.7 (703.9 to 1512.2)1086.9 (798.5 to 1479.6)1920.9 (1351.2 to 2730.8)1234.9 (710.6 to 2146.0)1284.8 (914.5 to 1805.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90255.4 (173.2 to 376.7)235.4 (164.9 to 335.9)178.3 (110.1 to 288.7)362.6 (208.1 to 632.0)234.1 (140.7 to 389.6)232.4 (151.2 to 357.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118202.2 (127.2 to 321.4)180.7 (113.0 to 288.9)151.5 (85.9 to 267.2)312.0 (160.1 to 607.8)212.1 (127.1 to 354.2)211.7 (136.9 to 327.2)
SecondaryRatio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 90 through Day 118
Reported as:
Number · ratio of GMT
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 901.1 (0.7 to 1.7)0.7 (0.4 to 1.3)1.2 (0.6 to 2.3)0.8 (0.4 to 1.5)
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 1180.9 (0.6 to 1.5)0.7 (0.4 to 1.3)0.9 (0.5 to 1.6)0.8 (0.4 to 1.3)
A/Kansas/14/2017 (H3N2) - Day 901.6 (1.2 to 2.2)1.1 (0.8 to 1.5)0.8 (0.5 to 1.2)0.9 (0.6 to 1.3)
A/Kansas/14/2017 (H3N2) - Day 1180.8 (0.5 to 1.4)0.9 (0.6 to 1.5)0.7 (0.4 to 1.2)0.6 (0.4 to 1.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.3 (0.8 to 2.1)1.1 (0.7 to 1.8)0.7 (0.4 to 1.2)0.6 (0.3 to 0.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1180.9 (0.6 to 1.6)1.0 (0.6 to 1.6)0.6 (0.3 to 1.2)0.7 (0.4 to 1.1)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 900.9 (0.5 to 1.5)0.7 (0.4 to 1.3)0.6 (0.3 to 1.4)0.6 (0.3 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1180.9 (0.5 to 1.7)0.7 (0.4 to 1.5)0.7 (0.3 to 1.6)0.7 (0.3 to 1.5)
SecondaryPercentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post-second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)0 (0 to 10)0 (0 to 12)0 (0 to 10)9 (2 to 24)6 (NA to 21)3 (NA to 15)
A/Kansas/14/2017 (H3N2)58 (41 to 74)30 (15 to 49)44 (27 to 62)56 (38 to 73)38 (21 to 56)26 (13 to 44)
B/Phuket/3073/2013 (B Yamagata lineage)8 (2 to 22)3 (NA to 17)3 (NA to 15)0 (0 to 10)9 (2 to 25)12 (3 to 27)
B/Maryland/15/2016 BX-69A (B Victoria lineage)3 (NA to 15)0 (0 to 12)0 (0 to 10)0 (0 to 10)0 (0 to 11)0 (0 to 10)
SecondaryGeometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 118
Reported as:
Geometric mean · Fold Rise
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
Fold RiseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Brisbane/02/2018 IVR-190 (H1N1)1.0 (0.9 to 1.2)1.0 (0.8 to 1.2)1.3 (1.1 to 1.5)1.4 (1.0 to 1.9)1.1 (0.8 to 1.4)1.3 (1.1 to 1.6)
A/Kansas/14/2017 (H3N2)5.1 (3.7 to 6.9)2.5 (1.9 to 3.3)3.9 (2.9 to 5.2)4.5 (2.9 to 7.0)3.9 (2.7 to 5.6)3.1 (2.3 to 4.3)
B/Phuket/3073/2013 (B Yamagata lineage)1.7 (1.3 to 2.2)1.2 (0.9 to 1.6)1.5 (1.2 to 1.7)1.5 (1.3 to 1.8)1.3 (0.9 to 1.8)1.7 (1.4 to 2.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage)0.8 (0.7 to 0.9)0.9 (0.7 to 1.0)0.9 (0.7 to 1.0)0.9 (0.7 to 1.0)0.9 (0.8 to 1.1)0.9 (0.8 to 1.1)
SecondaryGeometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8296.6 (215.3 to 408.5)582.8 (421.4 to 805.9)343.0 (256.2 to 459.2)398.7 (294.9 to 538.8)469.4 (314.4 to 700.6)347.5 (255.9 to 472.0)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57248.9 (175.2 to 353.7)520.8 (386.2 to 702.3)266.6 (184.4 to 385.5)602.3 (451.0 to 804.5)506.4 (354.6 to 723.1)408.9 (301.2 to 555.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90224.4 (162.3 to 310.2)456.9 (338.1 to 617.5)245.6 (169.1 to 356.7)565.1 (426.9 to 748.2)444.1 (314.1 to 628.1)383.9 (272.1 to 541.5)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118320.0 (224.7 to 455.7)570.2 (409.2 to 794.5)404.5 (264.2 to 619.4)962.2 (698.8 to 1324.9)839.0 (585.3 to 1202.7)554.9 (356.8 to 863.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8441.2 (335.5 to 580.2)525.7 (389.4 to 709.8)400.9 (290.8 to 552.6)480.1 (333.2 to 691.8)402.0 (278.4 to 580.3)344.7 (247.1 to 480.7)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57322.8 (241.0 to 432.3)338.5 (243.7 to 470.2)254.8 (177.6 to 365.3)422.2 (285.7 to 624.0)311.1 (216.9 to 446.3)286.7 (201.2 to 408.5)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90312.0 (231.6 to 420.3)339.0 (241.2 to 476.5)245.6 (170.6 to 353.7)410.4 (270.4 to 622.8)323.0 (219.2 to 475.9)303.8 (215.8 to 427.6)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118323.1 (235.1 to 443.9)281.8 (196.2 to 404.8)255.7 (170.6 to 383.3)404.5 (255.1 to 641.4)320.0 (224.4 to 456.3)329.9 (233.6 to 465.9)
A/Michigan/45/2015 X-275 (H1N1) - Day 8603.2 (442.7 to 821.9)561.3 (409.9 to 768.8)472.6 (340.3 to 656.3)673.3 (476.6 to 951.2)701.1 (471.8 to 1041.9)542.6 (382.1 to 770.6)
A/Michigan/45/2015 X-275 (H1N1) - Day 57629.0 (472.5 to 837.4)582.8 (431.6 to 787.0)440.3 (305.5 to 634.6)897.3 (648.4 to 1241.7)771.9 (527.9 to 1128.6)645.4 (460.9 to 903.8)
A/Michigan/45/2015 X-275 (H1N1) - Day 90526.9 (390.9 to 710.3)548.6 (401.8 to 749.1)366.9 (252.9 to 532.4)757.7 (550.4 to 1043.2)689.8 (476.7 to 998.2)571.8 (401.5 to 814.3)
A/Michigan/45/2015 X-275 (H1N1) - Day 118586.9 (436.0 to 790.0)519.8 (351.0 to 770.0)361.6 (242.1 to 540.3)868.9 (610.4 to 1237.0)697.9 (457.5 to 1064.6)715.9 (502.3 to 1020.4)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8714.3 (553.7 to 921.6)1061.3 (844.2 to 1334.2)889.5 (727.8 to 1087.3)1045.0 (801.2 to 1363.0)1019.0 (794.5 to 1306.9)875.7 (690.0 to 1111.4)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57629.0 (478.4 to 827.1)905.1 (688.4 to 1190.1)740.6 (584.7 to 938.0)1133.8 (887.1 to 1449.1)839.8 (617.7 to 1141.6)817.8 (638.6 to 1047.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90797.3 (595.9 to 1066.9)1129.4 (853.2 to 1495.2)849.1 (644.1 to 1119.4)1502.0 (1132.8 to 1991.7)1041.6 (747.5 to 1451.6)995.6 (752.0 to 1318.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118665.1 (499.2 to 886.2)874.3 (647.1 to 1181.1)792.8 (615.8 to 1020.6)1228.9 (924.0 to 1634.4)905.1 (649.8 to 1260.7)1065.4 (836.2 to 1357.5)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 82.0 (1.3 to 3.1)1.2 (0.8 to 1.8)1.2 (0.7 to 1.9)0.9 (0.6 to 1.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 572.1 (1.3 to 3.3)1.1 (0.6 to 1.8)0.8 (0.5 to 1.3)0.7 (0.4 to 1.0)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 902.0 (1.3 to 3.1)1.1 (0.7 to 1.8)0.8 (0.5 to 1.2)0.7 (0.4 to 1.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1181.8 (1.1 to 2.9)1.3 (0.7 to 2.2)0.9 (0.5 to 1.4)0.6 (0.3 to 1.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 81.2 (0.8 to 1.8)0.9 (0.6 to 1.4)0.8 (0.5 to 1.4)0.7 (0.4 to 1.2)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 571.0 (0.7 to 1.6)0.8 (0.5 to 1.2)0.7 (0.4 to 1.2)0.7 (0.4 to 1.1)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 901.1 (0.7 to 1.7)0.8 (0.5 to 1.3)0.8 (0.4 to 1.4)0.7 (0.4 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1180.9 (0.5 to 1.4)0.8 (0.5 to 1.3)0.8 (0.4 to 1.4)0.8 (0.5 to 1.4)
A/Michigan/45/2015 X-275 (H1N1) - Day 80.9 (0.6 to 1.4)0.8 (0.5 to 1.2)1.0 (0.6 to 1.7)0.8 (0.5 to 1.3)
A/Michigan/45/2015 X-275 (H1N1) - Day 570.9 (0.6 to 1.4)0.7 (0.4 to 1.1)0.9 (0.5 to 1.4)0.7 (0.5 to 1.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 901.0 (0.7 to 1.6)0.7 (0.4 to 1.1)0.9 (0.6 to 1.5)0.8 (0.5 to 1.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 1180.9 (0.5 to 1.4)0.6 (0.4 to 1.0)0.8 (0.5 to 1.4)0.8 (0.5 to 1.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 81.5 (1.1 to 2.1)1.2 (0.9 to 1.7)1.0 (0.7 to 1.4)0.8 (0.6 to 1.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.4 (1.0 to 2.1)1.2 (0.8 to 1.7)0.7 (0.5 to 1.1)0.7 (0.5 to 1.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.4 (1.0 to 2.1)1.1 (0.7 to 1.6)0.7 (0.5 to 1.1)0.7 (0.4 to 1.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.3 (0.9 to 2.0)1.2 (0.8 to 1.7)0.7 (0.5 to 1.1)0.9 (0.6 to 1.3)
SecondaryPercentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 827 (14 to 43)35 (20 to 53)30 (17 to 47)29 (16 to 46)47 (31 to 64)43 (28 to 59)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 5725 (13 to 41)30 (16 to 47)32 (18 to 49)43 (27 to 59)54 (37 to 71)44 (28 to 60)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 9024 (12 to 40)25 (12 to 42)32 (18 to 49)41 (26 to 58)41 (25 to 58)43 (27 to 59)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11842 (26 to 59)37 (20 to 56)50 (32 to 68)71 (53 to 85)72 (53 to 86)56 (38 to 73)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 827 (14 to 43)35 (20 to 53)35 (21 to 52)22 (11 to 38)47 (31 to 64)26 (14 to 42)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 5720 (9 to 36)22 (10 to 38)24 (11 to 40)15 (6 to 30)35 (20 to 53)22 (11 to 38)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 9022 (11 to 38)22 (10 to 39)24 (11 to 40)15 (6 to 31)35 (20 to 53)23 (11 to 38)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 11822 (10 to 39)17 (6 to 35)26 (13 to 44)15 (5 to 31)31 (16 to 50)29 (15 to 47)
A/Michigan/45/2015 X-275 (H1N1) - Day 822 (11 to 38)19 (8 to 35)23 (11 to 38)24 (12 to 40)39 (24 to 57)24 (12 to 39)
A/Michigan/45/2015 X-275 (H1N1) - Day 5723 (11 to 38)24 (12 to 41)24 (11 to 40)33 (19 to 49)46 (29 to 63)24 (12 to 40)
A/Michigan/45/2015 X-275 (H1N1) - Day 9020 (9 to 35)17 (6 to 33)16 (6 to 31)28 (15 to 45)38 (22 to 55)23 (11 to 38)
A/Michigan/45/2015 X-275 (H1N1) - Day 11822 (10 to 39)10 (2 to 27)24 (11 to 41)32 (17 to 51)47 (29 to 65)44 (27 to 62)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 820 (9 to 35)16 (6 to 32)20 (9 to 36)12 (4 to 26)29 (15 to 46)21 (10 to 37)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 5715 (6 to 30)19 (8 to 35)16 (6 to 31)18 (7 to 33)30 (16 to 47)22 (11 to 38)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 9022 (11 to 38)14 (5 to 29)13 (4 to 28)26 (13 to 42)27 (14 to 44)30 (17 to 47)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11817 (6 to 33)13 (4 to 31)15 (5 to 31)15 (5 to 31)16 (5 to 33)35 (20 to 54)
SecondaryPercentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)97 (86 to NA)100 (92 to 100)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57100 (91 to 100)100 (91 to 100)97 (86 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 9098 (87 to NA)100 (90 to 100)97 (86 to NA)100 (91 to 100)100 (91 to 100)98 (87 to NA)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118100 (90 to 100)100 (88 to 100)97 (85 to NA)100 (90 to 100)100 (89 to 100)100 (90 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)97 (86 to NA)100 (92 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57100 (91 to 100)100 (91 to 100)97 (86 to NA)100 (91 to 100)97 (86 to NA)100 (91 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 9098 (87 to NA)100 (90 to 100)97 (86 to NA)97 (87 to NA)97 (86 to NA)100 (91 to 100)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118100 (90 to 100)100 (88 to 100)97 (85 to NA)100 (90 to 100)94 (79 to NA)100 (90 to 100)
A/Michigan/45/2015 X-275 (H1N1) - Day 8100 (91 to 100)100 (91 to 100)98 (87 to NA)100 (91 to 100)97 (86 to NA)98 (87 to NA)
A/Michigan/45/2015 X-275 (H1N1) - Day 57100 (91 to 100)100 (91 to 100)95 (82 to NA)100 (91 to 100)97 (86 to NA)98 (87 to NA)
A/Michigan/45/2015 X-275 (H1N1) - Day 90100 (91 to 100)100 (90 to 100)95 (82 to NA)100 (91 to 100)97 (86 to NA)98 (87 to NA)
A/Michigan/45/2015 X-275 (H1N1) - Day 118100 (90 to 100)100 (88 to 100)94 (80 to NA)100 (90 to 100)97 (84 to NA)100 (90 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (92 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118100 (90 to 100)100 (88 to 100)100 (90 to 100)100 (90 to 100)100 (89 to 100)100 (90 to 100)
SecondaryGeometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 82.6 (1.7 to 3.9)3.0 (1.9 to 4.8)3.5 (2.1 to 5.9)2.4 (1.8 to 3.3)3.6 (2.6 to 5.1)3.2 (2.2 to 4.6)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 572.2 (1.5 to 3.1)2.7 (1.8 to 4.0)3.0 (2.0 to 4.5)3.6 (2.5 to 5.2)3.8 (2.7 to 5.3)3.6 (2.5 to 5.0)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 902.0 (1.4 to 2.7)2.2 (1.6 to 3.1)2.8 (1.9 to 4.1)3.4 (2.4 to 4.8)3.3 (2.4 to 4.6)3.3 (2.3 to 4.7)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1183.1 (2.2 to 4.5)2.8 (2.0 to 3.9)5.0 (3.3 to 7.7)6.1 (4.2 to 8.8)6.7 (4.3 to 10.2)5.3 (3.7 to 7.7)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 83.1 (2.0 to 5.0)3.5 (2.4 to 5.2)3.3 (2.2 to 5.1)1.9 (1.5 to 2.5)3.8 (2.5 to 5.6)2.6 (1.9 to 3.6)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 572.2 (1.5 to 3.2)2.3 (1.5 to 3.3)2.2 (1.5 to 3.2)1.7 (1.3 to 2.2)2.8 (2.0 to 4.0)2.1 (1.6 to 2.8)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 902.2 (1.5 to 3.3)2.4 (1.6 to 3.5)2.1 (1.5 to 2.9)1.7 (1.3 to 2.2)2.9 (2.1 to 4.1)2.3 (1.7 to 3.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1182.3 (1.5 to 3.5)2.1 (1.4 to 3.2)2.3 (1.7 to 3.1)1.6 (1.3 to 2.2)2.9 (2.0 to 4.2)2.6 (1.9 to 3.7)
A/Michigan/45/2015 X-275 (H1N1) - Day 82.5 (1.6 to 3.8)2.9 (1.9 to 4.4)2.7 (1.8 to 4.2)2.3 (1.7 to 3.0)3.8 (2.4 to 5.8)2.3 (1.7 to 3.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 572.4 (1.7 to 3.5)3.0 (1.9 to 4.6)2.7 (1.9 to 3.9)2.8 (2.2 to 3.6)4.2 (2.9 to 6.3)2.6 (2.0 to 3.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 902.2 (1.6 to 3.0)2.7 (1.8 to 4.1)2.3 (1.6 to 3.2)2.4 (1.9 to 3.0)3.8 (2.5 to 5.7)2.4 (1.8 to 3.0)
A/Michigan/45/2015 X-275 (H1N1) - Day 1182.2 (1.5 to 3.2)2.2 (1.4 to 3.7)2.5 (1.8 to 3.6)2.7 (2.1 to 3.4)3.8 (2.5 to 5.7)3.0 (2.2 to 4.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 81.9 (1.4 to 2.8)2.2 (1.6 to 3.1)1.8 (1.4 to 2.3)1.7 (1.2 to 2.4)3.1 (2.0 to 4.8)2.2 (1.8 to 2.8)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.7 (1.3 to 2.3)1.9 (1.3 to 2.8)1.5 (1.1 to 2.1)1.8 (1.3 to 2.5)2.5 (1.6 to 3.9)2.1 (1.6 to 2.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 902.2 (1.7 to 2.8)2.2 (1.5 to 3.3)1.8 (1.4 to 2.3)2.5 (1.7 to 3.5)3.1 (2.0 to 4.7)2.5 (2.0 to 3.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.8 (1.4 to 2.3)1.8 (1.1 to 2.7)1.8 (1.4 to 2.4)2.0 (1.4 to 2.9)2.6 (1.7 to 3.9)2.8 (2.2 to 3.5)
SecondaryGeometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · titer
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
titerFluzoneFluzone + AF03Fluzone + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8441.2 (330.9 to 588.3)501.7 (383.2 to 656.8)394.0 (291.6 to 532.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57262.2 (190.5 to 360.8)260.4 (195.3 to 347.2)202.8 (145.2 to 283.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90201.0 (143.3 to 282.0)201.6 (145.0 to 280.2)148.7 (103.3 to 214.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118258.9 (191.1 to 350.8)242.5 (170.2 to 345.5)200.2 (144.3 to 277.8)
B/Colorado/06/2017 (B Victoria lineage) - Day 8385.4 (306.3 to 484.9)566.6 (432.0 to 743.2)415.0 (326.7 to 527.1)
B/Colorado/06/2017 (B Victoria lineage) - Day 57309.1 (261.3 to 365.6)427.8 (313.8 to 583.3)311.4 (243.8 to 397.7)
B/Colorado/06/2017 (B Victoria lineage) - Day 90286.7 (241.4 to 340.5)391.7 (285.8 to 536.8)294.8 (234.2 to 371.0)
B/Colorado/06/2017 (B Victoria lineage) - Day 118373.3 (305.9 to 455.5)474.0 (351.9 to 638.3)400.4 (313.3 to 511.8)
A/Michigan/45/2015 X-275 (H1N1) - Day 8398.7 (303.7 to 523.3)419.9 (318.0 to 554.4)352.0 (265.0 to 467.6)
A/Michigan/45/2015 X-275 (H1N1) - Day 57218.6 (160.9 to 296.9)220.0 (161.6 to 299.5)155.7 (113.5 to 213.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 90189.5 (139.3 to 257.7)176.2 (127.9 to 242.7)125.1 (89.7 to 174.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 118261.4 (186.5 to 366.5)218.6 (156.0 to 306.2)177.2 (126.8 to 247.6)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8137.4 (111.7 to 169.1)208.0 (164.2 to 263.5)174.5 (143.5 to 212.2)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57117.1 (96.2 to 142.7)177.4 (140.3 to 224.1)157.1 (126.5 to 195.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90104.0 (86.2 to 125.4)156.9 (120.1 to 205.0)137.0 (113.1 to 166.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118115.3 (97.5 to 136.4)158.2 (117.3 to 213.3)150.5 (120.1 to 188.6)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 81.1 (0.8 to 1.7)0.9 (0.6 to 1.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 571.0 (0.7 to 1.5)0.8 (0.5 to 1.2)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 901.0 (0.6 to 1.6)0.7 (0.5 to 1.2)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1180.9 (0.6 to 1.5)0.8 (0.5 to 1.2)
B/Colorado/06/2017 (B Victoria lineage) - Day 81.5 (1.0 to 2.1)1.1 (0.8 to 1.5)
B/Colorado/06/2017 (B Victoria lineage) - Day 571.4 (1.0 to 2.0)1.0 (0.8 to 1.3)
B/Colorado/06/2017 (B Victoria lineage) - Day 901.4 (1.0 to 1.9)1.0 (0.8 to 1.4)
B/Colorado/06/2017 (B Victoria lineage) - Day 1181.3 (0.9 to 1.8)1.1 (0.8 to 1.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 81.1 (0.7 to 1.5)0.9 (0.6 to 1.3)
A/Michigan/45/2015 X-275 (H1N1) - Day 571.0 (0.7 to 1.5)0.7 (0.5 to 1.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 900.9 (0.6 to 1.4)0.7 (0.4 to 1.0)
A/Michigan/45/2015 X-275 (H1N1) - Day 1180.8 (0.5 to 1.3)0.7 (0.4 to 1.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 81.5 (1.1 to 2.1)1.3 (1.0 to 1.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.5 (1.1 to 2.0)1.3 (1.0 to 1.8)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.5 (1.1 to 2.1)1.3 (1.0 to 1.7)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.4 (1.0 to 1.9)1.3 (1.0 to 1.7)
SecondaryPercentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 57, 90, and 118.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 849 (33 to 65)62 (45 to 78)50 (34 to 66)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 5720 (9 to 36)22 (10 to 38)24 (11 to 40)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 9012 (4 to 26)8 (2 to 22)13 (4 to 28)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11828 (14 to 45)23 (10 to 42)32 (17 to 51)
B/Colorado/06/2017 (B Victoria lineage) - Day 820 (9 to 35)30 (16 to 47)13 (4 to 27)
B/Colorado/06/2017 (B Victoria lineage) - Day 5718 (7 to 33)16 (6 to 32)8 (2 to 21)
B/Colorado/06/2017 (B Victoria lineage) - Day 9010 (3 to 23)8 (2 to 22)5 (NA to 18)
B/Colorado/06/2017 (B Victoria lineage) - Day 11819 (8 to 36)20 (8 to 39)9 (2 to 24)
A/Michigan/45/2015 X-275 (H1N1) - Day 846 (31 to 63)57 (39 to 73)50 (34 to 66)
A/Michigan/45/2015 X-275 (H1N1) - Day 5715 (6 to 30)22 (10 to 38)11 (3 to 25)
A/Michigan/45/2015 X-275 (H1N1) - Day 9010 (3 to 23)11 (3 to 26)3 (NA to 14)
A/Michigan/45/2015 X-275 (H1N1) - Day 11825 (12 to 42)13 (4 to 31)24 (11 to 41)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 827 (14 to 43)30 (16 to 47)20 (9 to 36)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 5718 (7 to 33)16 (6 to 32)8 (2 to 21)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 9012 (4 to 26)11 (3 to 26)5 (NA to 18)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11817 (6 to 33)10 (2 to 27)6 (NA to 20)
SecondaryGeometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
fold riseFluzoneFluzone + AF03Fluzone + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 83.6 (2.6 to 4.9)4.3 (3.3 to 5.7)4.3 (3.2 to 5.8)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 572.0 (1.7 to 2.4)2.2 (1.8 to 2.8)2.4 (1.9 to 3.0)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 901.6 (1.4 to 1.9)1.7 (1.4 to 2.1)1.8 (1.5 to 2.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1182.2 (1.7 to 2.7)2.1 (1.6 to 2.8)2.7 (2.2 to 3.4)
B/Colorado/06/2017 (B Victoria lineage) - Day 82.2 (1.7 to 2.8)2.7 (2.0 to 3.6)1.9 (1.5 to 2.5)
B/Colorado/06/2017 (B Victoria lineage) - Day 571.8 (1.5 to 2.1)2.0 (1.6 to 2.6)1.5 (1.3 to 1.8)
B/Colorado/06/2017 (B Victoria lineage) - Day 901.6 (1.3 to 1.9)1.9 (1.5 to 2.4)1.5 (1.2 to 1.8)
B/Colorado/06/2017 (B Victoria lineage) - Day 1182.2 (1.8 to 2.7)2.5 (1.9 to 3.3)2.0 (1.6 to 2.3)
A/Michigan/45/2015 X-275 (H1N1) - Day 83.4 (2.6 to 4.5)3.9 (2.8 to 5.3)3.6 (2.7 to 4.9)
A/Michigan/45/2015 X-275 (H1N1) - Day 571.8 (1.5 to 2.1)2.0 (1.6 to 2.6)1.8 (1.4 to 2.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 901.6 (1.4 to 1.9)1.6 (1.2 to 2.0)1.4 (1.2 to 1.7)
A/Michigan/45/2015 X-275 (H1N1) - Day 1182.4 (1.9 to 2.9)2.0 (1.5 to 2.6)2.2 (1.8 to 2.8)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 82.2 (1.6 to 3.0)2.3 (1.8 to 2.9)1.9 (1.5 to 2.4)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.8 (1.5 to 2.3)2.0 (1.6 to 2.5)1.7 (1.5 to 2.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.6 (1.3 to 2.0)1.7 (1.4 to 2.2)1.5 (1.3 to 1.8)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181.9 (1.5 to 2.5)1.7 (1.3 to 2.2)1.7 (1.4 to 2.0)
SecondaryGeometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8140.6 (106.7 to 185.4)271.9 (201.0 to 367.9)154.0 (113.7 to 208.6)168.8 (129.9 to 219.5)210.6 (149.7 to 296.3)148.5 (111.9 to 196.9)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57150.2 (114.2 to 197.5)312.9 (243.1 to 402.6)195.6 (142.1 to 269.1)354.4 (264.8 to 474.5)309.0 (219.9 to 434.1)259.3 (189.4 to 355.0)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90132.1 (102.0 to 171.1)244.2 (177.7 to 335.6)152.8 (107.1 to 217.9)273.4 (185.7 to 402.6)265.7 (184.9 to 381.8)202.7 (144.5 to 284.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118161.8 (113.5 to 230.7)257.6 (188.3 to 352.4)224.1 (156.4 to 321.3)446.6 (300.1 to 664.6)409.5 (286.6 to 585.1)276.8 (178.2 to 430.0)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8309.6 (203.4 to 471.4)333.9 (223.3 to 499.3)261.6 (165.7 to 413.0)369.0 (227.9 to 597.7)243.2 (148.5 to 398.4)255.4 (169.9 to 383.8)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57365.7 (238.0 to 561.8)358.1 (231.2 to 554.8)232.1 (147.8 to 364.6)439.5 (255.9 to 755.0)300.2 (178.1 to 506.3)306.0 (198.5 to 471.7)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90255.4 (173.2 to 376.7)235.4 (164.9 to 335.9)178.3 (110.1 to 288.7)362.6 (208.1 to 632.0)234.1 (140.7 to 389.6)232.4 (151.2 to 357.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118202.2 (127.2 to 321.4)180.7 (113.0 to 288.9)151.5 (85.9 to 267.2)312.0 (160.1 to 607.8)212.1 (127.1 to 354.2)211.7 (136.9 to 327.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 86824.7 (5245.8 to 8878.7)7795.4 (5275.0 to 11520.0)5604.4 (3894.9 to 8064.2)6666.4 (4657.5 to 9541.7)8444.6 (5590.8 to 12755.0)5925.2 (4184.9 to 8389.3)
A/Michigan/45/2015 X-275 (H1N1) - Day 573437.4 (2218.8 to 5325.2)4437.2 (3179.4 to 6192.8)3335.0 (2194.5 to 5068.3)8293.9 (5358.8 to 12836.6)6502.7 (4251.4 to 9946.1)5791.6 (3915.1 to 8567.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 904623.9 (3377.1 to 6331.0)4965.3 (3475.0 to 7094.9)3255.1 (2163.5 to 4897.5)6518.8 (4528.7 to 9383.4)6113.7 (4061.6 to 9202.6)4837.8 (3410.7 to 6862.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 1185094.4 (3714.6 to 6986.7)5393.5 (3578.0 to 8130.2)3153.9 (2145.3 to 4636.8)8037.0 (5516.3 to 11709.7)6631.4 (4338.9 to 10135.2)6168.6 (4323.8 to 8800.5)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 81126.1 (727.4 to 1743.5)1049.1 (645.4 to 1705.3)1095.1 (817.4 to 1467.1)1515.8 (1031.0 to 2228.7)1154.5 (747.1 to 1784.0)824.8 (495.5 to 1372.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57859.6 (592.8 to 1246.6)1225.3 (851.4 to 1763.2)1037.6 (759.5 to 1417.5)1959.7 (1398.2 to 2746.6)1243.1 (834.1 to 1852.8)1173.0 (816.8 to 1684.5)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90681.0 (490.3 to 945.9)909.3 (638.8 to 1294.5)766.9 (541.3 to 1086.4)1371.5 (981.9 to 1915.7)953.5 (638.6 to 1423.7)754.8 (533.9 to 1066.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1181087.2 (762.1 to 1551.2)1031.7 (703.9 to 1512.2)1086.9 (798.5 to 1479.6)1920.9 (1351.2 to 2730.8)1234.9 (710.6 to 2146.0)1284.8 (914.5 to 1805.0)
SecondaryRatio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 81.9 (1.3 to 2.9)1.1 (0.7 to 1.6)1.2 (0.8 to 1.9)0.9 (0.6 to 1.3)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 572.1 (1.4 to 3.0)1.3 (0.9 to 2.0)0.9 (0.6 to 1.4)0.7 (0.5 to 1.1)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 901.8 (1.2 to 2.8)1.2 (0.8 to 1.8)1.0 (0.6 to 1.6)0.7 (0.4 to 1.2)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1181.6 (1.0 to 2.5)1.4 (0.8 to 2.3)0.9 (0.5 to 1.5)0.6 (0.3 to 1.1)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 81.1 (0.6 to 1.9)0.8 (0.5 to 1.6)0.7 (0.3 to 1.3)0.7 (0.4 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 571.0 (0.5 to 1.8)0.6 (0.3 to 1.2)0.7 (0.3 to 1.4)0.7 (0.4 to 1.4)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 900.9 (0.5 to 1.5)0.7 (0.4 to 1.3)0.6 (0.3 to 1.4)0.6 (0.3 to 1.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1180.9 (0.5 to 1.7)0.7 (0.4 to 1.5)0.7 (0.3 to 1.6)0.7 (0.3 to 1.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 81.1 (0.7 to 1.8)0.8 (0.5 to 1.3)1.3 (0.7 to 2.2)0.9 (0.5 to 1.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 571.3 (0.8 to 2.2)1.0 (0.5 to 1.8)0.8 (0.4 to 1.4)0.7 (0.4 to 1.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 901.1 (0.7 to 1.7)0.7 (0.4 to 1.2)0.9 (0.5 to 1.6)0.7 (0.5 to 1.2)
A/Michigan/45/2015 X-275 (H1N1) - Day 1181.1 (0.6 to 1.8)0.6 (0.4 to 1.0)0.8 (0.5 to 1.4)0.8 (0.5 to 1.3)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 80.9 (0.5 to 1.8)1.0 (0.6 to 1.6)0.8 (0.4 to 1.3)0.5 (0.3 to 1.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.4 (0.9 to 2.4)1.2 (0.7 to 1.9)0.6 (0.4 to 1.1)0.6 (0.4 to 1.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.3 (0.8 to 2.1)1.1 (0.7 to 1.8)0.7 (0.4 to 1.2)0.6 (0.3 to 0.9)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1180.9 (0.6 to 1.6)1.0 (0.6 to 1.6)0.6 (0.3 to 1.2)0.7 (0.4 to 1.1)
SecondaryPercentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 810 (3 to 23)16 (6 to 32)20 (9 to 36)15 (6 to 29)11 (3 to 25)7 (1 to 19)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 5710 (3 to 24)22 (10 to 38)18 (8 to 34)38 (23 to 54)27 (14 to 44)24 (12 to 40)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 9012 (4 to 26)11 (3 to 26)13 (4 to 28)23 (11 to 39)22 (10 to 38)10 (3 to 24)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11814 (5 to 29)10 (2 to 27)24 (11 to 41)32 (17 to 51)38 (21 to 56)24 (11 to 41)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 815 (6 to 29)24 (12 to 41)30 (17 to 47)15 (6 to 29)34 (20 to 51)31 (18 to 47)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 5725 (13 to 41)27 (14 to 44)32 (18 to 49)25 (13 to 41)35 (20 to 53)34 (20 to 51)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 9017 (7 to 32)19 (8 to 36)18 (8 to 34)13 (4 to 27)30 (16 to 47)25 (13 to 41)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 11814 (5 to 29)17 (6 to 35)18 (7 to 35)9 (2 to 24)28 (14 to 47)26 (13 to 44)
A/Michigan/45/2015 X-275 (H1N1) - Day 817 (7 to 32)24 (12 to 41)20 (9 to 36)20 (9 to 35)37 (22 to 54)24 (12 to 39)
A/Michigan/45/2015 X-275 (H1N1) - Day 5713 (4 to 27)11 (3 to 25)8 (2 to 21)23 (11 to 38)27 (14 to 44)17 (7 to 32)
A/Michigan/45/2015 X-275 (H1N1) - Day 9012 (4 to 26)11 (3 to 26)11 (3 to 25)8 (2 to 21)30 (16 to 47)13 (4 to 27)
A/Michigan/45/2015 X-275 (H1N1) - Day 11811 (3 to 26)10 (2 to 27)18 (7 to 35)18 (7 to 35)31 (16 to 50)21 (9 to 38)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 832 (18 to 48)11 (3 to 25)23 (11 to 38)24 (12 to 40)24 (11 to 40)19 (9 to 34)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 5728 (15 to 44)16 (6 to 32)21 (10 to 37)18 (7 to 33)22 (10 to 38)27 (14 to 43)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 9015 (6 to 29)11 (3 to 26)8 (2 to 21)15 (6 to 31)22 (10 to 38)15 (6 to 30)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 11822 (10 to 39)13 (4 to 31)18 (7 to 35)18 (7 to 35)16 (5 to 33)21 (9 to 38)
SecondaryPercentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 895 (83 to NA)100 (91 to 100)95 (83 to NA)95 (83 to NA)95 (82 to NA)93 (81 to 99)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 5798 (87 to NA)100 (91 to 100)97 (86 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 9095 (83 to NA)100 (90 to 100)89 (75 to 97)97 (87 to NA)95 (82 to NA)93 (80 to 98)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 11894 (81 to NA)100 (88 to 100)97 (85 to NA)100 (90 to 100)97 (84 to NA)97 (85 to NA)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 893 (80 to 98)97 (86 to NA)90 (76 to 97)95 (83 to NA)87 (72 to 96)98 (87 to NA)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 5795 (83 to NA)100 (91 to 100)95 (82 to NA)90 (76 to 97)89 (75 to 97)98 (87 to NA)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 9095 (83 to NA)100 (90 to 100)82 (66 to 92)87 (73 to 96)89 (75 to 97)93 (80 to 98)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 11889 (74 to 97)90 (73 to 98)71 (53 to 85)85 (69 to 95)91 (75 to 98)94 (80 to NA)
A/Michigan/45/2015 X-275 (H1N1) - Day 8100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (92 to 100)
A/Michigan/45/2015 X-275 (H1N1) - Day 5798 (87 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Michigan/45/2015 X-275 (H1N1) - Day 90100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Michigan/45/2015 X-275 (H1N1) - Day 118100 (90 to 100)100 (88 to 100)100 (90 to 100)100 (90 to 100)100 (89 to 100)100 (90 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 898 (87 to NA)97 (86 to NA)100 (91 to 100)100 (91 to 100)97 (86 to NA)95 (84 to NA)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90100 (91 to 100)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118100 (90 to 100)100 (88 to 100)100 (90 to 100)100 (90 to 100)97 (84 to NA)100 (90 to 100)
SecondaryGeometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains

Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 81.3 (1.0 to 1.8)1.8 (1.3 to 2.6)1.5 (1.1 to 2.1)1.1 (0.8 to 1.5)1.7 (1.3 to 2.3)1.3 (0.9 to 1.7)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 571.4 (1.1 to 1.8)2.1 (1.5 to 2.9)2.0 (1.4 to 2.9)2.3 (1.7 to 3.1)2.5 (1.9 to 3.3)2.1 (1.5 to 2.9)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 901.2 (0.9 to 1.6)1.6 (1.1 to 2.2)1.6 (1.2 to 2.2)1.8 (1.3 to 2.5)2.1 (1.5 to 3.0)1.7 (1.2 to 2.2)
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1181.7 (1.3 to 2.2)1.7 (1.3 to 2.3)2.4 (1.7 to 3.5)3.0 (2.3 to 4.1)3.5 (2.5 to 4.9)2.4 (1.8 to 3.3)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 82.8 (1.6 to 5.0)2.9 (1.8 to 4.9)2.8 (1.6 to 4.9)1.9 (1.3 to 2.6)3.0 (1.9 to 4.5)2.5 (1.8 to 3.6)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 573.2 (1.9 to 5.3)3.2 (1.7 to 5.8)2.5 (1.6 to 4.0)2.2 (1.5 to 3.2)3.6 (2.2 to 5.7)2.9 (2.0 to 4.4)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 902.3 (1.6 to 3.5)2.1 (1.3 to 3.6)2.0 (1.3 to 2.9)1.8 (1.3 to 2.5)2.8 (1.9 to 4.0)2.3 (1.6 to 3.2)
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1181.8 (1.2 to 2.9)1.7 (0.9 to 3.2)1.7 (1.1 to 2.8)1.5 (1.1 to 2.1)2.5 (1.6 to 3.8)2.2 (1.4 to 3.4)
A/Michigan/45/2015 X-275 (H1N1) - Day 82.2 (1.4 to 3.4)2.9 (1.7 to 4.8)2.6 (1.6 to 4.4)1.8 (1.3 to 2.4)3.8 (2.3 to 6.2)2.1 (1.5 to 3.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 571.0 (0.6 to 1.6)1.6 (1.0 to 2.8)1.7 (1.0 to 2.7)2.1 (1.5 to 2.9)3.0 (1.9 to 4.8)2.0 (1.4 to 3.1)
A/Michigan/45/2015 X-275 (H1N1) - Day 901.5 (1.0 to 2.2)1.7 (1.1 to 2.9)1.6 (1.0 to 2.6)1.6 (1.3 to 2.1)2.9 (1.8 to 4.4)1.7 (1.2 to 2.5)
A/Michigan/45/2015 X-275 (H1N1) - Day 1181.5 (1.0 to 2.2)1.7 (0.9 to 3.2)1.8 (1.1 to 2.9)2.0 (1.5 to 2.6)3.0 (1.8 to 4.9)2.3 (1.6 to 3.5)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 82.3 (1.4 to 4.0)1.8 (1.2 to 2.9)1.7 (1.2 to 2.4)1.8 (1.2 to 2.6)2.6 (1.6 to 4.3)1.5 (0.9 to 2.5)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 571.8 (1.2 to 2.6)2.1 (1.3 to 3.4)1.6 (1.1 to 2.4)2.2 (1.6 to 3.1)2.7 (1.7 to 4.3)2.1 (1.4 to 3.1)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 901.4 (1.0 to 1.9)1.5 (1.0 to 2.3)1.2 (0.9 to 1.7)1.6 (1.1 to 2.3)2.1 (1.3 to 3.4)1.4 (1.0 to 2.0)
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1182.2 (1.5 to 3.3)1.7 (1.0 to 2.8)1.9 (1.3 to 2.6)2.3 (1.6 to 3.3)2.4 (1.5 to 4.1)2.6 (1.9 to 3.5)
SecondaryGeometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains

Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 159.5 (39.7 to 89.3)113.1 (71.1 to 180.0)70.3 (44.2 to 111.6)87.8 (53.7 to 143.5)78.6 (49.2 to 125.4)63.5 (41.2 to 97.8)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8189.5 (138.6 to 259.0)440.0 (307.1 to 630.5)296.0 (210.3 to 416.6)261.2 (176.8 to 386.1)357.0 (223.6 to 570.0)299.6 (209.6 to 428.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29184.7 (126.9 to 269.0)415.0 (299.9 to 574.3)282.6 (195.5 to 408.5)400.9 (272.9 to 588.8)440.0 (279.1 to 693.7)366.3 (249.2 to 538.4)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57116.1 (78.6 to 171.5)272.9 (193.9 to 384.1)167.5 (113.0 to 248.1)314.5 (212.0 to 466.6)317.0 (204.6 to 491.2)281.9 (194.6 to 408.4)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90112.2 (75.4 to 167.0)264.0 (182.7 to 381.4)155.7 (102.6 to 236.3)272.7 (179.6 to 414.1)288.7 (182.3 to 457.1)244.6 (163.5 to 365.9)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118215.6 (137.9 to 337.1)351.0 (232.5 to 529.9)291.9 (197.3 to 432.0)583.9 (360.2 to 946.5)580.6 (362.1 to 930.8)388.4 (246.3 to 612.5)
A/Aksaray/4048/2016 [H3N2] - Day 172.9 (48.1 to 110.6)141.7 (87.1 to 230.3)76.6 (48.8 to 120.4)112.2 (72.3 to 174.1)80.0 (50.7 to 126.2)87.6 (60.5 to 126.8)
A/Aksaray/4048/2016 [H3N2] - Day 8178.6 (133.9 to 238.1)452.5 (337.9 to 606.1)259.9 (188.5 to 358.4)314.6 (230.5 to 429.5)394.7 (264.7 to 588.5)339.0 (251.7 to 456.7)
A/Aksaray/4048/2016 [H3N2] - Day 29174.1 (124.2 to 244.1)415.0 (298.8 to 576.4)222.3 (157.8 to 313.2)433.4 (326.5 to 575.2)456.8 (322.1 to 647.8)402.0 (295.2 to 547.6)
A/Aksaray/4048/2016 [H3N2] - Day 57146.7 (102.2 to 210.7)338.5 (250.4 to 457.6)188.5 (131.5 to 270.2)407.9 (303.0 to 549.0)423.8 (299.4 to 600.0)366.3 (269.9 to 497.2)
A/Aksaray/4048/2016 [H3N2] - Day 90140.9 (95.5 to 207.9)299.1 (212.8 to 420.6)157.1 (104.7 to 235.8)331.6 (241.6 to 455.0)323.0 (222.9 to 468.1)293.4 (214.1 to 402.2)
A/Aksaray/4048/2016 [H3N2] - Day 118320.0 (226.8 to 451.6)496.4 (336.9 to 731.2)438.9 (300.0 to 642.1)877.8 (610.8 to 1261.5)812.2 (548.2 to 1203.4)578.0 (394.5 to 846.7)
A/Kenya/105/2017 [H3N2] - Day 163.7 (44.3 to 91.6)123.1 (79.5 to 190.5)67.3 (42.7 to 106.1)105.7 (71.6 to 156.1)69.8 (44.7 to 108.9)78.0 (56.6 to 107.6)
A/Kenya/105/2017 [H3N2] - Day 8184.7 (140.7 to 242.6)483.2 (349.8 to 667.6)251.1 (184.4 to 341.8)312.0 (233.7 to 416.4)405.6 (273.8 to 600.9)374.3 (281.9 to 497.0)
A/Kenya/105/2017 [H3N2] - Day 29265.7 (186.9 to 377.8)646.2 (472.1 to 884.6)311.6 (225.0 to 431.4)656.9 (480.9 to 897.3)709.5 (494.9 to 1017.1)650.9 (494.7 to 856.5)
A/Kenya/105/2017 [H3N2] - Day 57182.2 (132.9 to 249.7)435.9 (311.3 to 610.4)216.2 (153.0 to 305.4)452.5 (339.2 to 603.8)416.0 (302.6 to 571.7)405.5 (309.0 to 532.1)
A/Kenya/105/2017 [H3N2] - Day 90202.7 (141.1 to 291.3)508.0 (357.5 to 721.7)226.3 (156.5 to 327.2)545.4 (404.8 to 734.9)516.0 (365.8 to 727.7)460.5 (335.9 to 631.2)
A/Kenya/105/2017 [H3N2] - Day 118269.1 (191.2 to 378.7)417.4 (275.4 to 632.6)301.0 (204.3 to 443.5)784.7 (546.9 to 1126.0)661.1 (445.1 to 982.0)543.7 (372.1 to 794.4)
A/Louisiana/13/2017 [H3N2] - Day 129.8 (20.7 to 42.8)61.5 (38.4 to 98.6)29.8 (19.6 to 45.4)43.5 (28.8 to 65.8)33.0 (23.0 to 47.4)34.8 (25.0 to 48.4)
A/Louisiana/13/2017 [H3N2] - Day 8103.1 (74.2 to 143.1)248.5 (168.5 to 366.5)121.3 (85.8 to 171.4)130.6 (94.3 to 181.0)148.7 (100.1 to 220.9)117.9 (83.2 to 167.0)
A/Louisiana/13/2017 [H3N2] - Day 29113.1 (80.3 to 159.5)271.7 (188.0 to 392.6)129.3 (90.5 to 184.7)226.3 (160.7 to 318.6)196.6 (133.3 to 290.0)180.1 (125.1 to 259.2)
A/Louisiana/13/2017 [H3N2] - Day 5774.6 (53.1 to 104.8)169.2 (115.9 to 247.2)86.8 (58.7 to 128.6)177.5 (128.0 to 246.3)132.7 (89.1 to 197.5)127.4 (89.8 to 180.5)
A/Louisiana/13/2017 [H3N2] - Day 9072.3 (50.9 to 102.7)163.1 (107.8 to 246.7)77.1 (51.5 to 115.4)176.4 (124.7 to 249.5)129.0 (84.6 to 196.6)124.5 (86.1 to 180.0)
A/Louisiana/13/2017 [H3N2] - Day 118256.4 (174.2 to 377.5)278.6 (178.3 to 435.4)253.1 (168.2 to 381.0)673.5 (445.3 to 1018.6)521.0 (334.9 to 810.5)365.3 (239.0 to 558.4)
A/Michigan/84/2016 [H3N2] - Day 182.1 (59.7 to 112.7)98.3 (67.6 to 143.0)62.8 (44.4 to 88.8)98.0 (69.8 to 137.5)58.1 (41.0 to 82.4)74.9 (54.8 to 102.3)
A/Michigan/84/2016 [H3N2] - Day 8115.1 (89.1 to 148.5)169.2 (120.6 to 237.4)96.8 (72.2 to 129.8)129.5 (91.8 to 182.7)100.5 (68.7 to 147.0)106.8 (76.0 to 150.0)
A/Michigan/84/2016 [H3N2] - Day 29124.2 (94.8 to 162.7)152.5 (105.7 to 220.0)94.7 (68.5 to 130.9)168.5 (119.0 to 238.8)108.0 (71.8 to 162.3)121.1 (85.0 to 172.4)
A/Michigan/84/2016 [H3N2] - Day 5795.1 (70.5 to 128.4)131.4 (92.0 to 187.8)75.7 (54.4 to 105.4)154.5 (108.1 to 221.0)81.5 (53.3 to 124.6)106.6 (74.1 to 153.4)
A/Michigan/84/2016 [H3N2] - Day 9099.7 (73.2 to 135.8)137.2 (95.0 to 198.0)79.3 (56.0 to 112.3)162.9 (113.8 to 233.2)78.5 (51.8 to 119.1)111.2 (74.2 to 166.5)
A/Michigan/84/2016 [H3N2] - Day 118129.5 (93.9 to 178.5)183.8 (122.3 to 276.2)121.5 (83.7 to 176.4)323.3 (231.3 to 451.8)153.2 (97.5 to 240.8)180.8 (118.8 to 275.2)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms was calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 11.9 (1.0 to 3.5)1.2 (0.6 to 2.2)0.9 (0.5 to 1.7)0.7 (0.4 to 1.4)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 82.3 (1.5 to 3.7)1.6 (1.0 to 2.5)1.4 (0.7 to 2.5)1.1 (0.7 to 1.9)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 292.2 (1.4 to 3.7)1.5 (0.9 to 2.6)1.1 (0.6 to 2.0)0.9 (0.5 to 1.6)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 572.4 (1.4 to 3.9)1.4 (0.8 to 2.5)1.0 (0.6 to 1.8)0.9 (0.5 to 1.5)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 902.4 (1.4 to 4.0)1.4 (0.8 to 2.4)1.1 (0.6 to 2.0)0.9 (0.5 to 1.6)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1181.6 (0.9 to 3.0)1.4 (0.8 to 2.4)1.0 (0.5 to 1.9)0.7 (0.3 to 1.3)
A/Aksaray/4048/2016 [H3N2] - Day 11.9 (1.0 to 3.6)1.1 (0.6 to 1.9)0.7 (0.4 to 1.3)0.8 (0.4 to 1.4)
A/Aksaray/4048/2016 [H3N2] - Day 82.5 (1.7 to 3.8)1.5 (1.0 to 2.2)1.3 (0.8 to 2.1)1.1 (0.7 to 1.6)
A/Aksaray/4048/2016 [H3N2] - Day 292.4 (1.5 to 3.8)1.3 (0.8 to 2.1)1.1 (0.7 to 1.6)0.9 (0.6 to 1.4)
A/Aksaray/4048/2016 [H3N2] - Day 572.3 (1.5 to 3.7)1.3 (0.8 to 2.1)1.0 (0.7 to 1.6)0.9 (0.6 to 1.4)
A/Aksaray/4048/2016 [H3N2] - Day 902.1 (1.3 to 3.5)1.1 (0.6 to 1.9)1.0 (0.6 to 1.6)0.9 (0.6 to 1.4)
A/Aksaray/4048/2016 [H3N2] - Day 1181.6 (0.9 to 2.6)1.4 (0.8 to 2.3)0.9 (0.5 to 1.6)0.7 (0.4 to 1.1)
A/Kenya/105/2017 [H3N2] - Day 11.9 (1.1 to 3.4)1.1 (0.6 to 1.9)0.7 (0.4 to 1.2)0.7 (0.4 to 1.2)
A/Kenya/105/2017 [H3N2] - Day 82.6 (1.7 to 4.0)1.4 (0.9 to 2.0)1.3 (0.8 to 2.1)1.2 (0.8 to 1.8)
A/Kenya/105/2017 [H3N2] - Day 292.4 (1.5 to 3.9)1.2 (0.7 to 1.9)1.1 (0.7 to 1.7)1.0 (0.7 to 1.5)
A/Kenya/105/2017 [H3N2] - Day 572.4 (1.5 to 3.8)1.2 (0.7 to 1.9)0.9 (0.6 to 1.4)0.9 (0.6 to 1.3)
A/Kenya/105/2017 [H3N2] - Day 902.5 (1.5 to 4.1)1.1 (0.7 to 1.9)0.9 (0.6 to 1.5)0.8 (0.6 to 1.3)
A/Kenya/105/2017 [H3N2] - Day 1181.6 (0.9 to 2.6)1.1 (0.7 to 1.9)0.8 (0.5 to 1.4)0.7 (0.4 to 1.2)
A/Louisiana/13/2017 [H3N2] - Day 12.1 (1.2 to 3.7)1.0 (0.6 to 1.7)0.8 (0.4 to 1.3)0.8 (0.5 to 1.3)
A/Louisiana/13/2017 [H3N2] - Day 82.4 (1.5 to 4.0)1.2 (0.7 to 1.9)1.1 (0.7 to 1.9)0.9 (0.6 to 1.4)
A/Louisiana/13/2017 [H3N2] - Day 292.4 (1.5 to 3.9)1.1 (0.7 to 1.9)0.9 (0.5 to 1.4)0.8 (0.5 to 1.3)
A/Louisiana/13/2017 [H3N2] - Day 572.3 (1.4 to 3.7)1.2 (0.7 to 1.9)0.7 (0.4 to 1.2)0.7 (0.4 to 1.1)
A/Louisiana/13/2017 [H3N2] - Day 902.3 (1.3 to 3.8)1.1 (0.6 to 1.8)0.7 (0.4 to 1.3)0.7 (0.4 to 1.2)
A/Louisiana/13/2017 [H3N2] - Day 1181.1 (0.6 to 1.9)1.0 (0.6 to 1.7)0.8 (0.4 to 1.4)0.5 (0.3 to 1.0)
A/Michigan/84/2016 [H3N2] - Day 11.2 (0.7 to 1.9)0.8 (0.5 to 1.2)0.6 (0.4 to 1.0)0.8 (0.5 to 1.2)
A/Michigan/84/2016 [H3N2] - Day 81.5 (1.0 to 2.2)0.8 (0.6 to 1.2)0.8 (0.5 to 1.3)0.8 (0.5 to 1.3)
A/Michigan/84/2016 [H3N2] - Day 291.2 (0.8 to 1.9)0.8 (0.5 to 1.2)0.6 (0.4 to 1.1)0.7 (0.4 to 1.2)
A/Michigan/84/2016 [H3N2] - Day 571.4 (0.9 to 2.2)0.8 (0.5 to 1.2)0.5 (0.3 to 0.9)0.7 (0.4 to 1.1)
A/Michigan/84/2016 [H3N2] - Day 901.4 (0.9 to 2.2)0.8 (0.5 to 1.3)0.5 (0.3 to 0.8)0.7 (0.4 to 1.2)
A/Michigan/84/2016 [H3N2] - Day 1181.4 (0.9 to 2.4)0.9 (0.6 to 1.5)0.5 (0.3 to 0.8)0.6 (0.3 to 0.9)
SecondaryPercentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 844 (28 to 60)38 (22 to 55)33 (19 to 49)27 (14 to 43)50 (33 to 67)48 (32 to 64)
A/Aksaray/4048/2016 [H3N2] - Day 827 (14 to 43)30 (16 to 47)30 (17 to 47)29 (16 to 46)47 (31 to 64)40 (26 to 57)
A/Kenya/105/2017 [H3N2] - Day 832 (18 to 48)38 (22 to 55)35 (21 to 52)32 (18 to 48)58 (41 to 74)57 (41 to 72)
A/Louisiana/13/2017 [H3N2] - Day 839 (24 to 55)41 (25 to 58)45 (29 to 62)29 (16 to 46)47 (31 to 64)40 (26 to 57)
A/Michigan/84/2016 [H3N2] - Day 810 (3 to 23)11 (3 to 25)10 (3 to 24)5 (NA to 17)11 (3 to 25)7 (1 to 19)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 2937 (22 to 53)31 (16 to 48)36 (21 to 53)55 (38 to 71)57 (39 to 73)63 (47 to 78)
A/Aksaray/4048/2016 [H3N2] - Day 2927 (14 to 43)31 (16 to 48)31 (17 to 48)48 (32 to 64)57 (39 to 73)59 (42 to 74)
A/Kenya/105/2017 [H3N2] - Day 2951 (35 to 67)56 (38 to 72)51 (35 to 68)65 (48 to 79)78 (62 to 90)78 (62 to 89)
A/Louisiana/13/2017 [H3N2] - Day 2941 (26 to 58)53 (35 to 70)56 (40 to 72)53 (36 to 68)73 (56 to 86)59 (42 to 74)
A/Michigan/84/2016 [H3N2] - Day 295 (NA to 17)8 (2 to 22)8 (2 to 21)10 (3 to 24)16 (6 to 32)12 (4 to 26)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 5718 (7 to 33)24 (12 to 41)26 (13 to 43)40 (25 to 57)49 (32 to 66)46 (31 to 63)
A/Aksaray/4048/2016 [H3N2] - Day 5723 (11 to 38)27 (14 to 44)29 (15 to 46)40 (25 to 57)57 (39 to 73)51 (35 to 67)
A/Kenya/105/2017 [H3N2] - Day 5723 (11 to 38)35 (20 to 53)39 (24 to 57)50 (34 to 66)62 (45 to 78)66 (49 to 80)
A/Louisiana/13/2017 [H3N2] - Day 5725 (13 to 41)30 (16 to 47)32 (18 to 49)45 (29 to 62)46 (29 to 63)44 (28 to 60)
A/Michigan/84/2016 [H3N2] - Day 573 (NA to 13)8 (2 to 22)5 (NA to 18)8 (2 to 20)11 (3 to 25)10 (3 to 23)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 9020 (9 to 35)19 (8 to 36)24 (11 to 40)38 (23 to 55)38 (22 to 55)45 (29 to 62)
A/Aksaray/4048/2016 [H3N2] - Day 9020 (9 to 35)19 (8 to 36)24 (11 to 40)38 (23 to 55)41 (25 to 58)45 (29 to 62)
A/Kenya/105/2017 [H3N2] - Day 9034 (20 to 51)36 (21 to 54)39 (24 to 57)59 (42 to 74)62 (45 to 78)65 (48 to 79)
A/Louisiana/13/2017 [H3N2] - Day 9027 (14 to 43)22 (10 to 39)24 (11 to 40)46 (30 to 63)43 (27 to 61)48 (32 to 64)
A/Michigan/84/2016 [H3N2] - Day 902 (NA to 13)6 (NA to 19)5 (NA to 18)8 (2 to 21)14 (5 to 29)13 (4 to 27)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 11853 (35 to 70)33 (17 to 53)47 (30 to 65)71 (53 to 85)69 (50 to 84)79 (62 to 91)
A/Aksaray/4048/2016 [H3N2] - Day 11858 (41 to 74)37 (20 to 56)62 (44 to 78)79 (62 to 91)75 (57 to 89)76 (59 to 89)
A/Kenya/105/2017 [H3N2] - Day 11856 (38 to 72)30 (15 to 49)62 (44 to 78)74 (56 to 87)88 (71 to 96)82 (65 to 93)
A/Louisiana/13/2017 [H3N2] - Day 11878 (61 to 90)47 (28 to 66)82 (65 to 93)85 (69 to 95)91 (75 to 98)91 (76 to 98)
A/Michigan/84/2016 [H3N2] - Day 11811 (3 to 26)13 (4 to 31)15 (5 to 31)38 (22 to 56)38 (21 to 56)26 (13 to 44)
SecondaryPercentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains

Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 178 (62 to 89)78 (62 to 90)73 (56 to 85)71 (54 to 84)71 (54 to 85)69 (53 to 82)
A/Aksaray/4048/2016 [H3N2] - Day 178 (62 to 89)81 (65 to 92)70 (53 to 83)80 (65 to 91)71 (54 to 85)81 (66 to 91)
A/Kenya/105/2017 [H3N2] - Day 178 (62 to 89)86 (71 to 95)70 (53 to 83)90 (77 to 97)74 (57 to 87)86 (71 to 95)
A/Louisiana/13/2017 [H3N2] - Day 154 (37 to 69)68 (50 to 82)43 (27 to 59)56 (40 to 72)47 (31 to 64)52 (36 to 68)
A/Michigan/84/2016 [H3N2] - Day 178 (62 to 89)81 (65 to 92)68 (51 to 81)80 (65 to 91)66 (49 to 80)83 (69 to 93)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 898 (87 to NA)100 (91 to 100)100 (91 to 100)93 (80 to 98)92 (79 to 98)100 (92 to 100)
A/Aksaray/4048/2016 [H3N2] - Day 898 (87 to NA)100 (91 to 100)98 (87 to NA)100 (91 to 100)97 (86 to NA)100 (92 to 100)
A/Kenya/105/2017 [H3N2] - Day 898 (87 to NA)100 (91 to 100)98 (87 to NA)100 (91 to 100)97 (86 to NA)100 (92 to 100)
A/Louisiana/13/2017 [H3N2] - Day 888 (74 to 96)95 (82 to NA)88 (73 to 96)88 (74 to 96)89 (75 to 97)86 (71 to 95)
A/Michigan/84/2016 [H3N2] - Day 893 (80 to 98)92 (78 to 98)93 (80 to 98)88 (74 to 96)79 (63 to 90)93 (81 to 99)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 2995 (83 to NA)100 (90 to 100)97 (87 to NA)98 (87 to NA)95 (82 to NA)98 (87 to NA)
A/Aksaray/4048/2016 [H3N2] - Day 2995 (83 to NA)100 (90 to 100)97 (87 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Kenya/105/2017 [H3N2] - Day 2998 (87 to NA)100 (90 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Louisiana/13/2017 [H3N2] - Day 2990 (77 to 97)97 (85 to NA)95 (83 to NA)95 (83 to NA)97 (86 to NA)95 (83 to NA)
A/Michigan/84/2016 [H3N2] - Day 2998 (87 to NA)94 (81 to NA)87 (73 to 96)90 (76 to 97)78 (62 to 90)90 (77 to 97)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 5783 (67 to 93)100 (91 to 100)92 (79 to 98)95 (83 to NA)95 (82 to NA)95 (83 to NA)
A/Aksaray/4048/2016 [H3N2] - Day 5790 (76 to 97)100 (91 to 100)97 (86 to NA)100 (91 to 100)97 (86 to NA)100 (91 to 100)
A/Kenya/105/2017 [H3N2] - Day 5795 (83 to NA)100 (91 to 100)95 (82 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Louisiana/13/2017 [H3N2] - Day 5778 (62 to 89)95 (82 to NA)82 (66 to 92)95 (83 to NA)92 (78 to 98)90 (77 to 97)
A/Michigan/84/2016 [H3N2] - Day 5783 (67 to 93)89 (75 to 97)82 (66 to 92)88 (73 to 96)76 (59 to 88)88 (74 to 96)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 9085 (71 to 94)100 (90 to 100)92 (79 to 98)97 (87 to NA)95 (82 to NA)95 (83 to NA)
A/Aksaray/4048/2016 [H3N2] - Day 9090 (77 to 97)100 (90 to 100)92 (79 to 98)100 (91 to 100)97 (86 to NA)100 (91 to 100)
A/Kenya/105/2017 [H3N2] - Day 9095 (83 to NA)100 (90 to 100)95 (82 to NA)100 (91 to 100)100 (91 to 100)100 (91 to 100)
A/Louisiana/13/2017 [H3N2] - Day 9078 (62 to 89)94 (81 to NA)74 (57 to 87)97 (87 to NA)89 (75 to 97)93 (80 to 98)
A/Michigan/84/2016 [H3N2] - Day 9083 (68 to 93)89 (74 to 97)79 (63 to 90)95 (83 to NA)76 (59 to 88)85 (70 to 94)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 11894 (81 to NA)100 (88 to 100)94 (80 to NA)100 (90 to 100)97 (84 to NA)100 (90 to 100)
A/Aksaray/4048/2016 [H3N2] - Day 118100 (90 to 100)100 (88 to 100)94 (80 to NA)100 (90 to 100)100 (89 to 100)100 (90 to 100)
A/Kenya/105/2017 [H3N2] - Day 118100 (90 to 100)100 (88 to 100)97 (85 to NA)100 (90 to 100)100 (89 to 100)100 (90 to 100)
A/Louisiana/13/2017 [H3N2] - Day 11897 (85 to NA)97 (83 to NA)94 (80 to NA)100 (90 to 100)97 (84 to NA)100 (90 to 100)
A/Michigan/84/2016 [H3N2] - Day 11894 (81 to NA)93 (78 to NA)88 (73 to 97)97 (85 to NA)84 (67 to 95)91 (76 to 98)
SecondaryGeometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains

Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 83.2 (2.2 to 4.6)3.9 (2.5 to 6.0)4.2 (2.6 to 6.8)3.0 (2.1 to 4.3)4.5 (2.9 to 7.1)4.7 (3.1 to 7.2)
A/Aksaray/4048/2016 [H3N2] - Day 82.4 (1.8 to 3.4)3.2 (2.1 to 5.0)3.4 (2.2 to 5.2)2.8 (2.0 to 4.0)4.9 (3.2 to 7.7)3.9 (2.7 to 5.5)
A/Kenya/105/2017 [H3N2] - Day 82.9 (2.1 to 4.1)3.9 (2.6 to 6.0)3.7 (2.4 to 5.7)3.0 (2.1 to 4.1)5.8 (3.8 to 9.0)4.8 (3.4 to 6.7)
A/Louisiana/13/2017 [H3N2] - Day 83.5 (2.5 to 4.8)4.0 (2.8 to 5.8)4.1 (2.8 to 5.9)3.0 (2.2 to 4.1)4.5 (3.2 to 6.4)3.4 (2.4 to 4.7)
A/Michigan/84/2016 [H3N2] - Day 81.4 (1.2 to 1.7)1.7 (1.4 to 2.1)1.5 (1.3 to 1.9)1.3 (1.1 to 1.5)1.7 (1.3 to 2.4)1.4 (1.2 to 1.7)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 293.1 (2.2 to 4.5)3.4 (2.2 to 5.2)4.2 (2.7 to 6.6)4.6 (3.1 to 6.7)5.2 (3.6 to 7.6)5.5 (3.7 to 8.3)
A/Aksaray/4048/2016 [H3N2] - Day 292.4 (1.7 to 3.3)2.7 (1.8 to 4.0)3.1 (2.1 to 4.5)3.8 (2.6 to 5.5)5.3 (3.5 to 8.0)4.4 (3.0 to 6.5)
A/Kenya/105/2017 [H3N2] - Day 294.2 (2.9 to 5.9)4.8 (3.2 to 7.2)4.9 (3.3 to 7.1)6.1 (4.2 to 8.8)9.5 (6.2 to 14.5)8.1 (5.8 to 11.2)
A/Louisiana/13/2017 [H3N2] - Day 293.8 (2.8 to 5.1)4.2 (3.0 to 5.9)4.6 (3.4 to 6.3)5.0 (3.6 to 7.0)5.7 (4.1 to 7.8)5.1 (3.6 to 7.3)
A/Michigan/84/2016 [H3N2] - Day 291.5 (1.3 to 1.8)1.6 (1.3 to 1.9)1.5 (1.3 to 1.7)1.7 (1.3 to 2.1)1.8 (1.3 to 2.4)1.6 (1.3 to 2.0)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 572.0 (1.4 to 2.8)2.4 (1.6 to 3.5)2.6 (1.7 to 4.0)3.6 (2.5 to 5.1)3.9 (2.7 to 5.6)4.2 (2.9 to 6.3)
A/Aksaray/4048/2016 [H3N2] - Day 572.0 (1.5 to 2.8)2.4 (1.6 to 3.6)2.7 (1.9 to 3.9)3.6 (2.5 to 5.1)5.1 (3.3 to 7.6)4.0 (2.8 to 5.6)
A/Kenya/105/2017 [H3N2] - Day 572.9 (2.2 to 3.9)3.5 (2.5 to 5.0)3.6 (2.5 to 5.1)4.2 (3.0 to 5.9)5.8 (3.9 to 8.6)5.0 (3.7 to 6.9)
A/Louisiana/13/2017 [H3N2] - Day 572.6 (2.0 to 3.4)2.8 (2.0 to 3.8)3.3 (2.4 to 4.5)3.9 (3.0 to 5.2)4.0 (3.0 to 5.3)3.6 (2.7 to 4.9)
A/Michigan/84/2016 [H3N2] - Day 571.2 (1.0 to 1.3)1.3 (1.1 to 1.7)1.2 (1.1 to 1.4)1.5 (1.2 to 1.9)1.4 (1.1 to 1.8)1.4 (1.1 to 1.8)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 901.9 (1.4 to 2.5)2.1 (1.5 to 3.1)2.4 (1.7 to 3.5)3.1 (2.3 to 4.4)3.5 (2.5 to 5.1)3.6 (2.5 to 5.3)
A/Aksaray/4048/2016 [H3N2] - Day 901.9 (1.5 to 2.6)1.9 (1.4 to 2.7)2.3 (1.6 to 3.2)2.9 (2.1 to 4.0)3.9 (2.6 to 5.7)3.2 (2.3 to 4.4)
A/Kenya/105/2017 [H3N2] - Day 903.2 (2.4 to 4.2)3.8 (2.6 to 5.4)3.8 (2.6 to 5.4)5.1 (3.6 to 7.1)7.1 (4.8 to 10.6)5.7 (4.1 to 7.9)
A/Louisiana/13/2017 [H3N2] - Day 902.4 (1.9 to 3.1)2.5 (1.9 to 3.4)2.9 (2.2 to 3.9)3.8 (2.9 to 4.8)3.9 (2.9 to 5.2)3.5 (2.5 to 4.8)
A/Michigan/84/2016 [H3N2] - Day 901.2 (1.1 to 1.4)1.4 (1.2 to 1.7)1.3 (1.1 to 1.5)1.6 (1.3 to 1.9)1.4 (1.1 to 1.7)1.5 (1.2 to 1.9)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1184.1 (2.9 to 5.9)2.8 (1.9 to 4.1)4.9 (3.2 to 7.3)6.8 (4.3 to 10.7)8.1 (5.1 to 12.9)6.6 (4.5 to 9.6)
A/Aksaray/4048/2016 [H3N2] - Day 1185.1 (3.5 to 7.4)3.1 (2.2 to 4.5)6.5 (4.3 to 9.8)8.1 (5.4 to 12.0)11.0 (6.6 to 18.1)6.9 (4.9 to 9.6)
A/Kenya/105/2017 [H3N2] - Day 1184.8 (3.4 to 6.9)3.1 (2.2 to 4.2)5.2 (3.4 to 7.8)7.8 (5.1 to 12.0)10.4 (6.8 to 15.9)7.5 (5.4 to 10.6)
A/Louisiana/13/2017 [H3N2] - Day 1189.8 (6.2 to 15.5)4.1 (2.8 to 6.0)9.7 (6.5 to 14.6)15.5 (9.5 to 25.4)16.5 (10.2 to 26.7)11.1 (7.7 to 15.9)
A/Michigan/84/2016 [H3N2] - Day 1181.7 (1.4 to 2.0)1.6 (1.3 to 2.1)2.0 (1.6 to 2.4)2.9 (2.2 to 3.7)2.8 (1.9 to 4.0)2.4 (1.9 to 3.0)
SecondaryGeometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
titerFluzoneFluzone + AF03Fluzone + CpG55
A/Townsville/51/2016 H6N2 - Day 116.6 (12.8 to 21.5)20.2 (15.5 to 26.3)14.5 (10.7 to 19.6)
A/Townsville/51/2016 H6N2 - Day 834.1 (27.3 to 42.5)49.6 (39.8 to 61.8)35.1 (27.8 to 44.4)
A/Townsville/51/2016 H6N2 - Day 2921.9 (17.8 to 27.1)35.6 (27.5 to 46.1)23.3 (17.6 to 30.7)
A/Townsville/51/2016 H6N2 - Day 5726.2 (20.7 to 33.1)37.1 (29.0 to 47.4)24.2 (17.9 to 32.7)
A/Townsville/51/2016 H6N2 - Day 9022.7 (17.9 to 28.8)34.6 (25.9 to 46.2)24.0 (17.4 to 33.1)
A/Townsville/51/2016 H6N2 - Day 11832.4 (24.7 to 42.4)39.1 (29.3 to 52.1)29.5 (21.3 to 40.8)
A/Cameroon/9766/2017 H6N1 - Day 148.2 (33.0 to 70.4)47.3 (33.5 to 67.0)40.0 (26.7 to 59.8)
A/Cameroon/9766/2017 H6N1 - Day 8104.0 (79.2 to 136.5)117.5 (91.0 to 151.6)91.1 (66.5 to 124.7)
A/Cameroon/9766/2017 H6N1 - Day 2980.7 (60.4 to 107.8)95.1 (69.6 to 130.1)68.2 (49.9 to 93.1)
A/Cameroon/9766/2017 H6N1 - Day 5776.6 (55.3 to 106.1)76.3 (55.2 to 105.6)53.6 (37.0 to 77.6)
A/Cameroon/9766/2017 H6N1 - Day 9069.3 (49.7 to 96.6)66.6 (47.0 to 94.5)48.9 (33.9 to 70.4)
A/Cameroon/9766/2017 H6N1 - Day 11883.1 (58.2 to 118.8)81.9 (56.1 to 119.5)62.0 (42.9 to 89.6)
A/Hubeiwujiagang/SWL310/2013 - Day 1108.5 (73.7 to 159.7)105.0 (74.1 to 148.6)92.7 (60.6 to 141.7)
A/Hubeiwujiagang/SWL310/2013 - Day 8197.7 (147.4 to 265.0)191.2 (141.7 to 257.8)167.1 (120.8 to 231.1)
A/Hubeiwujiagang/SWL310/2013 - Day 29143.3 (104.2 to 197.3)161.5 (112.3 to 232.4)128.1 (91.0 to 180.4)
A/Hubeiwujiagang/SWL310/2013 - Day 57144.2 (103.7 to 200.5)151.3 (105.8 to 216.3)117.3 (80.0 to 172.7)
A/Hubeiwujiagang/SWL310/2013 - Day 90139.8 (99.2 to 196.8)145.3 (100.2 to 210.7)113.1 (76.9 to 166.5)
A/Hubeiwujiagang/SWL310/2013 - Day 118141.2 (98.8 to 201.7)160.0 (108.1 to 236.8)130.5 (90.0 to 189.3)
A/Oman/5532/2017 H6N1 - Day 137.7 (26.4 to 53.9)35.1 (25.1 to 49.0)31.7 (20.9 to 48.0)
A/Oman/5532/2017 H6N1 - Day 880.7 (59.6 to 109.2)100.2 (75.3 to 133.3)75.3 (55.8 to 101.5)
A/Oman/5532/2017 H6N1 - Day 2965.9 (49.7 to 87.3)74.8 (55.4 to 101.0)54.1 (39.5 to 74.1)
A/Oman/5532/2017 H6N1 - Day 5763.3 (45.8 to 87.6)62.1 (44.2 to 87.4)48.4 (33.0 to 71.2)
A/Oman/5532/2017 H6N1 - Day 9057.5 (40.1 to 82.6)53.9 (38.1 to 76.3)40.4 (27.7 to 58.9)
A/Oman/5532/2017 H6N1 - Day 11872.7 (51.1 to 103.3)70.5 (47.6 to 104.2)54.9 (38.0 to 79.2)
A/Aksaray/4048/2016 H6N2 - Day 133.2 (23.7 to 46.5)45.2 (32.7 to 62.4)28.5 (19.3 to 42.2)
A/Aksaray/4048/2016 H6N2 - Day 872.9 (57.1 to 93.1)117.5 (93.9 to 147.0)81.4 (62.4 to 106.2)
A/Aksaray/4048/2016 H6N2 - Day 2959.5 (47.2 to 75.1)102.8 (79.6 to 132.6)62.9 (47.2 to 84.0)
A/Aksaray/4048/2016 H6N2 - Day 5751.9 (39.6 to 67.9)90.4 (70.9 to 115.1)56.6 (40.6 to 78.7)
A/Aksaray/4048/2016 H6N2 - Day 9060.0 (45.2 to 79.7)96.1 (74.8 to 123.3)63.1 (43.8 to 90.8)
A/Aksaray/4048/2016 H6N2 - Day 11869.9 (52.3 to 93.5)91.9 (69.4 to 121.8)68.0 (48.4 to 95.3)
A/Louisiana/13/2017 H6N2 - Day 1124.2 (94.1 to 163.8)154.1 (109.9 to 216.0)126.6 (86.8 to 184.7)
A/Louisiana/13/2017 H6N2 - Day 8181.6 (137.6 to 239.7)317.0 (247.9 to 405.4)216.7 (161.8 to 290.1)
A/Louisiana/13/2017 H6N2 - Day 29181.6 (140.7 to 234.4)305.0 (230.0 to 404.3)201.6 (149.2 to 272.4)
A/Louisiana/13/2017 H6N2 - Day 57153.2 (117.4 to 199.9)250.8 (188.1 to 334.6)183.5 (131.6 to 225.8)
A/Louisiana/13/2017 H6N2 - Day 90144.6 (111.8 to 186.9)215.6 (162.7 to 285.9)157.1 (113.3 to 217.8)
A/Louisiana/13/2017 H6N2 - Day 118167.9 (127.2 to 221.6)266.0 (198.3 to 356.8)212.8 (142.8 to 317.2)
SecondaryRatio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55
A/Townsville/51/2016 H6N2 - Day 11.2 (0.8 to 1.7)0.9 (0.6 to 1.3)
A/Cameroon/9766/2017 H6N1 - Day 11.0 (0.6 to 1.6)0.8 (0.5 to 1.4)
A/Hubeiwujiagang/SWL310/2013 - Day 11.0 (0.6 to 1.6)0.9 (0.5 to 1.5)
A/Oman/5532/2017 H6N1 - Day 10.9 (0.6 to 1.5)0.8 (0.5 to 1.4)
A/Aksaray/4048/2016 H6N2 - Day 11.4 (0.9 to 2.2)0.9 (0.5 to 1.4)
A/Townsville/51/2016 H6N2 - Day 81.5 (1.1 to 2.0)1.0 (0.8 to 1.4)
A/Cameroon/9766/2017 H6N1 - Day 81.1 (0.8 to 1.6)0.9 (0.6 to 1.3)
A/Hubeiwujiagang/SWL310/2013 - Day 81.0 (0.6 to 1.5)0.8 (0.5 to 1.3)
A/Oman/5532/2017 H6N1 - Day 81.2 (0.8 to 1.9)0.9 (0.6 to 1.4)
A/Aksaray/4048/2016 H6N2 - Day 81.6 (1.2 to 2.2)1.1 (0.8 to 1.6)
A/Townsville/51/2016 H6N2 - Day 291.6 (1.2 to 2.3)1.1 (0.8 to 1.5)
A/Cameroon/9766/2017 H6N1 - Day 291.2 (0.8 to 1.8)0.8 (0.6 to 1.3)
A/Hubeiwujiagang/SWL310/2013 - Day 291.1 (0.7 to 1.8)0.9 (0.6 to 1.4)
A/Oman/5532/2017 H6N1 - Day 291.1 (0.8 to 1.7)0.8 (0.5 to 1.2)
A/Aksaray/4048/2016 H6N2 - Day 291.7 (1.2 to 2.4)1.1 (0.7 to 1.5)
A/Townsville/51/2016 H6N2 - Day 571.4 (1.0 to 2.0)0.9 (0.6 to 1.3)
A/Cameroon/9766/2017 H6N1 - Day 571.0 (0.6 to 1.6)0.7 (0.4 to 1.1)
A/Hubeiwujiagang/SWL310/2013 - Day 571.0 (0.7 to 1.7)0.8 (0.5 to 1.3)
A/Oman/5532/2017 H6N1 - Day 571.0 (0.6 to 1.6)0.8 (0.5 to 1.3)
A/Aksaray/4048/2016 H6N2 - Day 571.7 (1.2 to 2.5)1.1 (0.7 to 1.7)
A/Townsville/51/2016 H6N2 - Day 901.5 (1.1 to 2.2)1.1 (0.7 to 1.6)
A/Cameroon/9766/2017 H6N1 - Day 901.0 (0.6 to 1.5)0.7 (0.4 to 1.1)
A/Hubeiwujiagang/SWL310/2013 - Day 901.0 (0.6 to 1.7)0.8 (0.5 to 1.3)
A/Oman/5532/2017 H6N1 - Day 900.9 (0.6 to 1.5)0.7 (0.4 to 1.2)
A/Aksaray/4048/2016 H6N2 - Day 901.6 (1.1 to 2.3)1.1 (0.7 to 1.7)
A/Townsville/51/2016 H6N2 - Day 1181.2 (0.8 to 1.8)0.9 (0.6 to 1.4)
A/Cameroon/9766/2017 H6N1 - Day 1181.0 (0.6 to 1.6)0.7 (0.5 to 1.2)
A/Hubeiwujiagang/SWL310/2013 - Day 1181.1 (0.7 to 1.9)0.9 (0.6 to 1.5)
A/Oman/5532/2017 H6N1 - Day 1181.0 (0.6 to 1.6)0.8 (0.5 to 1.2)
A/Aksaray/4048/2016 H6N2 - Day 1181.3 (0.9 to 2.0)1.0 (0.6 to 1.5)
A/Louisiana/13/2017 H6N2 - Day 11.2 (0.8 to 1.9)1.0 (0.6 to 1.6)
A/Louisiana/13/2017 H6N2 - Day 81.7 (1.2 to 2.5)1.2 (0.8 to 1.8)
A/Louisiana/13/2017 H6N2 - Day 291.7 (1.2 to 2.4)1.1 (0.8 to 1.6)
A/Louisiana/13/2017 H6N2 - Day 571.6 (1.1 to 2.4)1.2 (0.8 to 1.8)
A/Louisiana/13/2017 H6N2 - Day 901.5 (1.0 to 2.2)1.1 (0.7 to 1.6)
A/Louisiana/13/2017 H6N2 - Day 1181.6 (1.1 to 2.4)1.3 (0.8 to 2.0)
SecondaryPercentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 29, 57, 90, and 118.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55
A/Townsville/51/2016 H6N2 - Day 817 (7 to 32)27 (14 to 44)25 (13 to 41)
A/Cameroon/9766/2017 H6N1 - Day 824 (12 to 40)32 (18 to 50)38 (23 to 54)
A/Hubeiwujiagang/SWL310/2013 - Day 817 (7 to 32)14 (5 to 29)18 (7 to 33)
A/Oman/5532/2017 H6N1 - Day 827 (14 to 43)41 (25 to 58)28 (15 to 44)
A/Aksaray/4048/2016 H6N2 - Day 829 (16 to 46)38 (22 to 55)38 (23 to 54)
A/Louisiana/13/2017 H6N2 - Day 810 (3 to 23)27 (14 to 44)10 (3 to 24)
A/Townsville/51/2016 H6N2 - Day 2910 (3 to 23)14 (5 to 29)5 (NA to 17)
A/Cameroon/9766/2017 H6N1 - Day 2915 (6 to 29)22 (10 to 39)18 (8 to 34)
A/Hubeiwujiagang/SWL310/2013 - Day 295 (NA to 17)14 (5 to 29)3 (NA to 13)
A/Oman/5532/2017 H6N1 - Day 2917 (7 to 32)19 (8 to 36)18 (8 to 34)
A/Aksaray/4048/2016 H6N2 - Day 2917 (7 to 32)25 (12 to 42)33 (19 to 50)
A/Louisiana/13/2017 H6N2 - Day 297 (2 to 20)19 (8 to 36)13 (4 to 27)
A/Townsville/51/2016 H6N2 - Day 578 (2 to 20)11 (3 to 25)5 (NA to 18)
A/Cameroon/9766/2017 H6N1 - Day 578 (2 to 20)11 (3 to 25)5 (NA to 18)
A/Hubeiwujiagang/SWL310/2013 - Day 570 (0 to 9)8 (2 to 22)3 (NA to 14)
A/Oman/5532/2017 H6N1 - Day 5713 (4 to 27)8 (2 to 22)11 (3 to 25)
A/Aksaray/4048/2016 H6N2 - Day 575 (NA to 17)19 (8 to 35)18 (8 to 34)
A/Louisiana/13/2017 H6N2 - Day 573 (NA to 13)11 (3 to 25)8 (2 to 21)
A/Townsville/51/2016 H6N2 - Day 902 (NA to 13)6 (NA to 19)5 (NA to 18)
A/Cameroon/9766/2017 H6N1 - Day 905 (NA to 17)11 (3 to 26)3 (NA to 14)
A/Hubeiwujiagang/SWL310/2013 - Day 905 (NA to 17)11 (3 to 26)3 (NA to 14)
A/Oman/5532/2017 H6N1 - Day 9010 (3 to 23)6 (NA to 19)5 (NA to 18)
A/Aksaray/4048/2016 H6N2 - Day 907 (2 to 20)17 (6 to 33)24 (11 to 40)
A/Louisiana/13/2017 H6N2 - Day 902 (NA to 13)6 (NA to 19)3 (NA to 14)
A/Townsville/51/2016 H6N2 - Day 11822 (10 to 39)10 (2 to 27)18 (7 to 35)
A/Cameroon/9766/2017 H6N1 - Day 1188 (2 to 22)13 (4 to 31)15 (5 to 31)
A/Hubeiwujiagang/SWL310/2013 - Day 11811 (3 to 26)10 (2 to 27)15 (5 to 31)
A/Oman/5532/2017 H6N1 - Day 11819 (8 to 36)17 (6 to 35)18 (7 to 35)
A/Aksaray/4048/2016 H6N2 - Day 11825 (12 to 42)17 (6 to 35)32 (17 to 51)
A/Louisiana/13/2017 H6N2 - Day 1188 (2 to 22)10 (2 to 27)18 (7 to 35)
SecondaryGeometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms

Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
fold riseFluzoneFluzone + AF03Fluzone + CpG55
A/Townsville/51/2016 H6N2 - Day 82.1 (1.7 to 2.4)2.5 (2.0 to 3.1)2.4 (2.0 to 2.9)
A/Cameroon/9766/2017 H6N1 - Day 82.2 (1.7 to 2.8)2.5 (2.0 to 3.1)2.3 (1.8 to 3.0)
A/Hubeiwujiagang/SWL310/2013 - Day 81.8 (1.5 to 2.3)1.8 (1.5 to 2.2)1.8 (1.5 to 2.2)
A/Oman/5532/2017 H6N1 - Day 82.1 (1.6 to 2.8)2.9 (2.3 to 3.6)2.4 (1.8 to 3.1)
A/Aksaray/4048/2016 H6N2 - Day 82.2 (1.8 to 2.7)2.6 (2.0 to 3.4)2.9 (2.3 to 3.6)
A/Louisiana/13/2017 H6N2 - Day 81.5 (1.2 to 1.8)2.1 (1.6 to 2.7)1.7 (1.4 to 2.1)
A/Townsville/51/2016 H6N2 - Day 291.3 (1.1 to 1.5)1.7 (1.4 to 2.1)1.6 (1.4 to 1.9)
A/Cameroon/9766/2017 H6N1 - Day 291.7 (1.4 to 2.1)2.0 (1.6 to 2.5)1.8 (1.5 to 2.2)
A/Hubeiwujiagang/SWL310/2013 - Day 291.3 (1.1 to 1.5)1.6 (1.3 to 1.9)1.5 (1.3 to 1.7)
A/Oman/5532/2017 H6N1 - Day 291.7 (1.4 to 2.1)2.1 (1.8 to 2.6)1.8 (1.5 to 2.2)
A/Aksaray/4048/2016 H6N2 - Day 291.8 (1.5 to 2.1)2.2 (1.7 to 2.7)2.3 (1.9 to 2.8)
A/Louisiana/13/2017 H6N2 - Day 291.5 (1.3 to 1.7)1.9 (1.5 to 2.4)1.6 (1.4 to 1.9)
A/Townsville/51/2016 H6N2 - Day 571.6 (1.4 to 1.9)1.8 (1.5 to 2.2)1.7 (1.5 to 2.0)
A/Cameroon/9766/2017 H6N1 - Day 571.5 (1.3 to 1.8)1.6 (1.3 to 1.9)1.5 (1.2 to 1.7)
A/Hubeiwujiagang/SWL310/2013 - Day 571.3 (1.1 to 1.5)1.4 (1.2 to 1.7)1.4 (1.2 to 1.6)
A/Oman/5532/2017 H6N1 - Day 571.6 (1.4 to 1.9)1.8 (1.5 to 2.1)1.7 (1.4 to 2.0)
A/Aksaray/4048/2016 H6N2 - Day 571.6 (1.4 to 1.8)2.0 (1.6 to 2.5)2.0 (1.7 to 2.3)
A/Louisiana/13/2017 H6N2 - Day 571.3 (1.1 to 1.5)1.6 (1.3 to 2.0)1.5 (1.3 to 1.8)
A/Townsville/51/2016 H6N2 - Day 901.4 (1.2 to 1.5)1.6 (1.4 to 1.9)1.7 (1.5 to 1.9)
A/Cameroon/9766/2017 H6N1 - Day 901.4 (1.2 to 1.7)1.4 (1.2 to 1.7)1.3 (1.1 to 1.5)
A/Hubeiwujiagang/SWL310/2013 - Day 901.3 (1.1 to 1.5)1.4 (1.2 to 1.7)1.3 (1.2 to 1.5)
A/Oman/5532/2017 H6N1 - Day 901.5 (1.3 to 1.8)1.5 (1.3 to 1.8)1.4 (1.2 to 1.6)
A/Aksaray/4048/2016 H6N2 - Day 901.8 (1.6 to 2.0)2.0 (1.6 to 2.5)2.2 (1.9 to 2.6)
A/Louisiana/13/2017 H6N2 - Day 901.2 (1.0 to 1.3)1.3 (1.1 to 1.7)1.3 (1.1 to 1.5)
A/Townsville/51/2016 H6N2 - Day 1182.1 (1.7 to 2.7)2.0 (1.6 to 2.4)2.1 (1.8 to 2.5)
A/Cameroon/9766/2017 H6N1 - Day 1181.8 (1.5 to 2.3)1.7 (1.3 to 2.1)2.0 (1.7 to 2.4)
A/Hubeiwujiagang/SWL310/2013 - Day 1181.4 (1.1 to 1.7)1.6 (1.2 to 2.0)1.7 (1.4 to 2.1)
A/Oman/5532/2017 H6N1 - Day 1182.0 (1.6 to 2.5)2.0 (1.6 to 2.5)2.2 (1.8 to 2.7)
A/Aksaray/4048/2016 H6N2 - Day 1182.4 (1.9 to 2.9)2.0 (1.6 to 2.6)2.4 (1.9 to 3.0)
A/Louisiana/13/2017 H6N2 - Day 1181.5 (1.2 to 1.9)1.7 (1.4 to 2.2)1.7 (1.4 to 2.1)
SecondaryGeometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · titer
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
titerFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1293.5 (177.4 to 485.3)535.4 (308.2 to 930.0)348.3 (204.3 to 593.9)412.1 (240.7 to 705.3)388.6 (219.7 to 687.4)307.9 (189.9 to 499.4)
A/Aksaray/4048/2016 [H3N2] - Day 134.2 (27.9 to 42.0)46.7 (34.5 to 63.3)40.5 (32.0 to 51.3)47.1 (36.3 to 61.2)40.3 (32.6 to 49.9)40.9 (33.1 to 50.6)
A/Kenya/105/2017 [H3N2] - Day 1183.2 (135.0 to 248.5)294.8 (212.0 to 410.0)218.7 (162.1 to 295.1)226.8 (171.6 to 299.8)232.4 (174.5 to 309.5)217.9 (170.6 to 278.3)
A/Michigan/84/2016 [H3N2] - Day 1858.5 (602.9 to 1222.5)852.9 (590.6 to 1231.8)616.3 (438.6 to 866.0)736.5 (520.1 to 1042.8)667.0 (483.7 to 919.9)624.2 (455.1 to 856.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8830.8 (534.9 to 1290.4)2284.7 (1470.2 to 3550.6)1656.1 (1098.6 to 2496.5)1212.0 (783.0 to 1876.0)1795.8 (1069.5 to 3015.4)1425.2 (913.7 to 2222.9)
A/Aksaray/4048/2016 [H3N2] - Day 845.4 (33.8 to 61.0)101.3 (71.1 to 144.4)65.8 (46.4 to 93.2)88.2 (64.1 to 121.5)121.5 (81.1 to 182.2)86.9 (60.8 to 124.0)
A/Kenya/105/2017 [H3N2] - Day 8267.6 (191.5 to 374.1)486.9 (362.5 to 654.0)312.8 (231.4 to 422.9)431.4 (332.7 to 559.6)559.0 (377.8 to 827.1)505.9 (384.6 to 665.2)
A/Michigan/84/2016 [H3N2] - Day 81237.6 (972.5 to 1574.9)1798.5 (1329.9 to 2432.3)1088.9 (833.9 to 1421.9)1051.7 (802.0 to 1379.2)852.0 (591.9 to 1226.5)882.3 (652.2 to 1193.5)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29819.1 (531.4 to 1262.6)2083.9 (1428.1 to 3041.0)1416.0 (928.8 to 2158.7)1940.2 (1267.2 to 2970.8)2359.5 (1437.0 to 3874.2)1922.4 (1287.1 to 2871.3)
A/Aksaray/4048/2016 [H3N2] - Day 2943.3 (35.1 to 53.5)70.9 (53.4 to 94.0)48.9 (40.2 to 59.6)82.0 (63.0 to 106.7)107.0 (73.8 to 155.1)81.4 (59.0 to 112.4)
A/Kenya/105/2017 [H3N2] - Day 29344.4 (247.5 to 479.3)698.1 (498.6 to 977.6)421.4 (303.5 to 585.2)821.9 (618.7 to 1091.7)983.9 (672.0 to 1440.4)790.8 (597.1 to 1047.2)
A/Michigan/84/2016 [H3N2] - Day 291232.8 (936.8 to 1622.3)1541.8 (1141.7 to 2082.1)1032.4 (782.2 to 1362.6)1424.0 (1017.3 to 1993.5)1020.1 (669.5 to 1554.2)1054.4 (724.7 to 1534.0)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57396.0 (245.2 to 639.7)1000.2 (630.6 to 1586.5)720.2 (448.3 to 1157.0)1086.0 (692.4 to 1703.1)1208.6 (710.9 to 2054.8)1032.9 (659.4 to 1618.0)
A/Aksaray/4048/2016 [H3N2] - Day 5753.7 (36.9 to 78.0)117.6 (83.2 to 166.2)61.8 (42.4 to 90.0)151.8 (111.0 to 207.6)156.5 (110.1 to 222.5)140.0 (101.3 to 193.4)
A/Kenya/105/2017 [H3N2] - Day 57237.7 (168.6 to 335.2)469.4 (338.5 to 650.9)283.7 (187.6 to 429.0)634.0 (467.3 to 860.1)688.0 (478.2 to 989.7)517.7 (364.7 to 735.1)
A/Michigan/84/2016 [H3N2] - Day 571071.2 (844.9 to 1358.2)1602.1 (1174.2 to 2186.0)946.6 (701.5 to 1277.2)1533.4 (1127.0 to 2086.4)904.9 (631.5 to 1296.8)1158.3 (829.3 to 1617.9)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90556.7 (338.1 to 916.8)1501.0 (927.7 to 2316.6)946.6 (567.5 to 1579.1)1331.6 (812.5 to 2182.4)1563.9 (898.7 to 2721.5)1268.5 (799.6 to 2012.6)
A/Aksaray/4048/2016 [H3N2] - Day 9062.4 (41.3 to 94.2)111.0 (77.1 to 159.6)64.7 (44.7 to 93.6)149.1 (110.6 to 201.0)147.2 (104.2 to 208.0)129.6 (91.8 to 183.1)
A/Kenya/105/2017 [H3N2] - Day 90151.6 (107.9 to 212.9)315.4 (220.1 to 452.1)200.1 (130.8 to 306.1)431.5 (300.0 to 620.7)444.3 (297.7 to 663.0)385.5 (270.5 to 549.4)
A/Michigan/84/2016 [H3N2] - Day 90841.2 (627.1 to 1128.5)1268.8 (907.6 to 1773.7)778.8 (576.1 to 1052.8)1297.0 (905.5 to 1857.7)733.5 (488.2 to 1102.1)905.2 (611.5 to 1340.1)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1181128.1 (631.8 to 2014.4)1723.8 (1046.1 to 2840.8)1631.8 (995.5 to 2674.9)2739.4 (1472.3 to 5096.9)3672.3 (2051.3 to 6574.1)2233.2 (1295.2 to 3850.4)
A/Aksaray/4048/2016 [H3N2] - Day 11894.6 (66.8 to 134.1)139.0 (89.9 to 215.1)150.1 (103.6 to 217.3)326.1 (213.5 to 498.3)296.5 (200.9 to 437.6)241.3 (149.0 to 390.9)
A/Kenya/105/2017 [H3N2] - Day 118300.7 (210.5 to 429.5)400.6 (253.2 to 633.8)369.1 (235.3 to 538.0)936.6 (636.7 to 1377.7)965.5 (623.9 to 1494.3)733.9 (478.8 to 1125.0)
A/Michigan/84/2016 [H3N2] - Day 1181382.3 (1083.1 to 1764.2)1785.2 (1201.1 to 2653.4)1487.2 (1108.4 to 1996.6)2572.0 (1842.0 to 3591.3)1537.3 (1005.4 to 2350.7)1641.9 (1095.4 to 2461.0)
SecondaryRatio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms

Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.

Time frame:
Day 1, Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · ratio of GMT
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
ratio of GMTFluzone + AF03Fluzone + CpG55Flublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 11.8 (0.9 to 3.8)1.2 (0.6 to 2.4)0.9 (0.4 to 2.0)0.7 (0.4 to 1.5)
A/Aksaray/4048/2016 [H3N2] - Day 11.4 (1.0 to 2.0)1.2 (0.9 to 1.6)0.9 (0.6 to 1.2)0.9 (0.6 to 1.2)
A/Kenya/105/2017 [H3N2] - Day 11.6 (1.0 to 2.5)1.2 (0.8 to 1.8)1.0 (0.7 to 1.5)1.0 (0.7 to 1.4)
A/Michigan/84/2016 [H3N2] - Day 11.0 (0.6 to 1.6)0.7 (0.4 to 1.2)0.9 (0.6 to 1.4)0.8 (0.5 to 1.3)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 82.7 (1.5 to 5.1)2.0 (1.1 to 3.6)1.5 (0.8 to 2.9)1.2 (0.6 to 2.2)
A/Aksaray/4048/2016 [H3N2] - Day 82.2 (1.4 to 3.5)1.4 (0.9 to 2.3)1.4 (0.8 to 2.3)1.0 (0.6 to 1.6)
A/Kenya/105/2017 [H3N2] - Day 81.8 (1.2 to 2.8)1.2 (0.8 to 1.8)1.3 (0.8 to 2.1)1.2 (0.8 to 1.7)
A/Michigan/84/2016 [H3N2] - Day 81.5 (1.0 to 2.1)0.9 (0.6 to 1.3)0.8 (0.5 to 1.3)0.8 (0.6 to 1.3)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 292.5 (1.4 to 4.5)1.7 (1.0 to 3.1)1.2 (0.6 to 2.3)1.0 (0.6 to 1.8)
A/Aksaray/4048/2016 [H3N2] - Day 291.6 (1.2 to 2.3)1.1 (0.8 to 1.5)1.3 (0.8 to 2.0)1.0 (0.7 to 1.5)
A/Kenya/105/2017 [H3N2] - Day 292.0 (1.3 to 3.2)1.2 (0.8 to 1.9)1.2 (0.7 to 1.9)1.0 (0.6 to 1.4)
A/Michigan/84/2016 [H3N2] - Day 291.3 (0.8 to 1.9)0.8 (0.6 to 1.2)0.7 (0.4 to 1.2)0.7 (0.5 to 1.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 572.5 (1.3 to 4.9)1.8 (0.9 to 3.5)1.1 (0.6 to 2.2)1.0 (0.5 to 1.8)
A/Aksaray/4048/2016 [H3N2] - Day 572.2 (1.3 to 3.6)1.2 (0.7 to 1.9)1.0 (0.6 to 1.6)0.9 (0.6 to 1.4)
A/Kenya/105/2017 [H3N2] - Day 572.0 (1.2 to 3.1)1.2 (0.7 to 2.0)1.1 (0.7 to 1.7)0.8 (0.5 to 1.3)
A/Michigan/84/2016 [H3N2] - Day 571.5 (1.0 to 2.2)0.9 (0.6 to 1.3)0.6 (0.4 to 0.9)0.8 (0.5 to 1.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 902.7 (1.4 to 5.2)1.7 (0.8 to 3.4)1.2 (0.6 to 2.4)1.0 (0.5 to 1.9)
A/Aksaray/4048/2016 [H3N2] - Day 901.8 (1.0 to 3.1)1.0 (0.6 to 1.8)1.0 (0.6 to 1.5)0.9 (0.6 to 1.4)
A/Kenya/105/2017 [H3N2] - Day 902.1 (1.3 to 3.4)1.3 (0.8 to 2.3)1.0 (0.6 to 1.8)0.9 (0.5 to 1.5)
A/Michigan/84/2016 [H3N2] - Day 901.5 (1.0 to 2.3)0.9 (0.6 to 1.4)0.6 (0.3 to 1.0)0.7 (0.4 to 1.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1181.5 (0.7 to 3.2)1.4 (0.7 to 3.1)1.3 (0.6 to 3.1)0.8 (0.4 to 1.8)
A/Aksaray/4048/2016 [H3N2] - Day 1181.5 (0.8 to 2.5)1.6 (1.0 to 2.6)0.9 (0.5 to 1.6)0.7 (0.4 to 1.4)
A/Kenya/105/2017 [H3N2] - Day 1181.3 (0.8 to 2.4)1.2 (0.7 to 2.0)1.0 (0.6 to 1.8)0.8 (0.4 to 1.4)
A/Michigan/84/2016 [H3N2] - Day 1181.3 (0.8 to 2.0)1.1 (0.7 to 1.6)0.6 (0.4 to 1.0)0.6 (0.4 to 1.1)
SecondaryPercentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains

Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
percentage of participantsFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 824 (12 to 40)32 (18 to 50)33 (19 to 49)27 (14 to 43)42 (26 to 59)45 (30 to 61)
A/Aksaray/4048/2016 [H3N2] - Day 87 (2 to 20)16 (6 to 32)13 (4 to 27)20 (9 to 35)34 (20 to 51)21 (10 to 37)
A/Kenya/105/2017 [H3N2] - Day 812 (4 to 26)16 (6 to 32)15 (6 to 30)15 (6 to 29)24 (11 to 40)24 (12 to 39)
A/Michigan/84/2016 [H3N2] - Day 812 (4 to 26)19 (8 to 35)13 (4 to 27)10 (3 to 23)8 (2 to 21)12 (4 to 26)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 2934 (20 to 51)33 (19 to 51)31 (17 to 48)55 (38 to 71)51 (34 to 68)49 (33 to 65)
A/Aksaray/4048/2016 [H3N2] - Day 297 (2 to 20)11 (3 to 26)5 (NA to 17)10 (3 to 24)24 (12 to 41)17 (7 to 32)
A/Kenya/105/2017 [H3N2] - Day 2915 (6 to 29)22 (10 to 39)21 (9 to 36)35 (21 to 52)43 (27 to 61)39 (24 to 55)
A/Michigan/84/2016 [H3N2] - Day 2912 (4 to 26)17 (6 to 33)10 (3 to 24)15 (6 to 30)11 (3 to 25)12 (4 to 26)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 5715 (6 to 30)16 (6 to 32)26 (13 to 43)33 (19 to 49)35 (20 to 53)32 (18 to 48)
A/Aksaray/4048/2016 [H3N2] - Day 5713 (4 to 27)14 (5 to 29)11 (3 to 25)38 (23 to 54)49 (32 to 66)37 (22 to 53)
A/Kenya/105/2017 [H3N2] - Day 578 (2 to 20)19 (8 to 35)16 (6 to 31)30 (17 to 47)32 (18 to 50)29 (16 to 46)
A/Michigan/84/2016 [H3N2] - Day 5713 (4 to 27)16 (6 to 32)3 (NA to 14)13 (4 to 27)8 (2 to 22)12 (4 to 26)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 9020 (9 to 35)25 (12 to 42)24 (11 to 40)33 (19 to 50)41 (25 to 58)40 (25 to 57)
A/Aksaray/4048/2016 [H3N2] - Day 9017 (7 to 32)17 (6 to 33)11 (3 to 25)33 (19 to 50)49 (32 to 66)30 (17 to 47)
A/Kenya/105/2017 [H3N2] - Day 905 (NA to 17)8 (2 to 22)8 (2 to 21)18 (8 to 34)22 (10 to 38)18 (7 to 33)
A/Michigan/84/2016 [H3N2] - Day 900 (0 to 9)8 (2 to 22)3 (NA to 14)10 (3 to 24)8 (2 to 22)8 (2 to 20)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 11847 (30 to 65)33 (17 to 53)44 (27 to 62)56 (38 to 73)72 (53 to 86)68 (49 to 83)
A/Aksaray/4048/2016 [H3N2] - Day 11833 (19 to 51)27 (12 to 46)35 (20 to 54)79 (62 to 91)69 (50 to 84)62 (44 to 78)
A/Kenya/105/2017 [H3N2] - Day 11819 (8 to 36)10 (2 to 27)21 (9 to 38)44 (27 to 62)44 (26 to 62)38 (22 to 56)
A/Michigan/84/2016 [H3N2] - Day 11819 (8 to 36)17 (6 to 35)18 (7 to 35)32 (17 to 51)22 (9 to 40)35 (20 to 54)
SecondaryGeometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains

Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.

Time frame:
Day 8, Day 29, Day 57, Day 90, Day 118
Reported as:
Geometric mean · fold rise
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
fold riseFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
A/Shandonglaicheng/1763/2016 [H3N2] - Day 82.8 (1.8 to 4.4)4.3 (2.6 to 7.0)4.8 (2.9 to 7.7)2.9 (2.0 to 4.3)4.6 (2.8 to 7.7)4.6 (2.8 to 7.7)
A/Aksaray/4048/2016 [H3N2] - Day 81.3 (1.0 to 1.7)2.2 (1.6 to 3.0)1.6 (1.2 to 2.2)1.9 (1.4 to 2.5)3.0 (2.1 to 4.3)2.1 (1.5 to 3.0)
A/Kenya/105/2017 [H3N2] - Day 81.5 (1.1 to 2.0)1.7 (1.2 to 2.3)1.4 (1.1 to 1.9)1.9 (1.5 to 2.5)2.4 (1.7 to 3.5)2.3 (1.7 to 3.1)
A/Michigan/84/2016 [H3N2] - Day 81.4 (1.1 to 1.9)2.1 (1.5 to 2.9)1.8 (1.3 to 2.3)1.4 (1.2 to 1.8)1.3 (1.0 to 1.7)1.4 (1.1 to 1.8)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 292.8 (1.8 to 4.3)3.4 (2.1 to 5.5)4.3 (2.6 to 7.1)4.7 (3.1 to 7.2)5.5 (3.5 to 8.5)5.9 (3.6 to 9.7)
A/Aksaray/4048/2016 [H3N2] - Day 291.3 (1.0 to 1.5)1.5 (1.1 to 2.0)1.2 (1.0 to 1.5)1.7 (1.3 to 2.3)2.6 (1.8 to 3.7)2.0 (1.4 to 2.8)
A/Kenya/105/2017 [H3N2] - Day 291.9 (1.4 to 2.5)2.3 (1.6 to 3.2)1.9 (1.4 to 2.7)3.6 (2.6 to 4.8)4.1 (2.9 to 5.8)3.5 (2.6 to 4.8)
A/Michigan/84/2016 [H3N2] - Day 291.4 (1.1 to 1.8)1.8 (1.3 to 2.3)1.6 (1.4 to 1.9)1.9 (1.4 to 2.5)1.5 (1.2 to 1.9)1.7 (1.3 to 2.2)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 571.4 (0.9 to 2.1)1.9 (1.2 to 2.9)2.3 (1.4 to 3.6)2.6 (1.8 to 3.9)3.0 (1.9 to 4.7)3.2 (2.0 to 5.2)
A/Aksaray/4048/2016 [H3N2] - Day 571.6 (1.2 to 2.1)2.5 (1.9 to 3.4)1.6 (1.2 to 2.1)3.2 (2.4 to 4.2)3.8 (2.7 to 5.2)3.4 (2.4 to 4.7)
A/Kenya/105/2017 [H3N2] - Day 571.3 (1.0 to 1.8)1.6 (1.1 to 2.3)1.3 (0.9 to 1.9)2.7 (2.0 to 3.7)2.9 (2.2 to 3.9)2.3 (1.6 to 3.3)
A/Michigan/84/2016 [H3N2] - Day 571.3 (1.0 to 1.6)1.9 (1.4 to 2.5)1.5 (1.3 to 1.8)2.0 (1.5 to 2.6)1.4 (1.1 to 1.7)1.8 (1.4 to 2.4)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 901.9 (1.3 to 2.7)2.5 (1.5 to 4.0)3.0 (2.0 to 4.6)3.3 (2.3 to 4.8)3.8 (2.4 to 6.0)3.8 (2.4 to 6.1)
A/Aksaray/4048/2016 [H3N2] - Day 901.8 (1.3 to 2.5)2.3 (1.8 to 3.0)1.6 (1.3 to 2.1)3.1 (2.4 to 4.1)3.5 (2.6 to 4.8)3.1 (2.3 to 4.3)
A/Kenya/105/2017 [H3N2] - Day 900.8 (0.6 to 1.1)1.0 (0.7 to 1.4)0.9 (0.7 to 1.3)1.9 (1.4 to 2.6)1.9 (1.3 to 2.7)1.7 (1.3 to 2.3)
A/Michigan/84/2016 [H3N2] - Day 901.0 (0.8 to 1.2)1.5 (1.1 to 1.9)1.3 (1.0 to 1.5)1.7 (1.3 to 2.2)1.1 (0.8 to 1.4)1.4 (1.1 to 1.9)
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1184.6 (2.9 to 7.3)2.8 (1.8 to 4.3)5.7 (3.5 to 9.4)6.8 (4.2 to 11.0)9.9 (5.8 to 16.8)7.8 (4.7 to 12.8)
A/Aksaray/4048/2016 [H3N2] - Day 1183.0 (2.2 to 4.1)2.9 (2.0 to 4.1)3.7 (2.6 to 5.3)6.9 (4.8 to 9.9)7.3 (5.0 to 10.6)6.1 (4.0 to 9.5)
A/Kenya/105/2017 [H3N2] - Day 1181.8 (1.3 to 2.6)1.2 (0.9 to 1.7)1.8 (1.3 to 2.4)4.2 (3.0 to 6.0)4.2 (2.9 to 6.2)3.5 (2.5 to 4.9)
A/Michigan/84/2016 [H3N2] - Day 1181.7 (1.3 to 2.3)1.8 (1.4 to 2.3)2.4 (1.9 to 3.0)3.2 (2.3 to 4.3)2.3 (1.7 to 3.1)2.6 (1.9 to 3.7)

Adverse events

Collected over Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fluzone0/41 (0%)0/41 (0%)37/41 (90.2%)
Fluzone + AF030/37 (0%)1/37 (2.7%)36/37 (97.3%)
Fluzone + CpG550/40 (0%)0/40 (0%)40/40 (100%)
Flublok0/42 (0%)0/42 (0%)36/42 (85.7%)
Flublok + AF030/37 (0%)0/37 (0%)34/37 (91.9%)
Flublok + CpG550/43 (0%)1/43 (2.3%)43/43 (100%)
Most frequent serious events
Most frequent serious events
EventFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Clostridium Difficile ColitisInfections and infestations0/411/370/400/420/370/43
Chronic Left Knee PainMusculoskeletal and connective tissue disorders0/410/370/400/420/371/43
Most frequent other events
Showing 10 of 23
Most frequent other events
EventFluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55
Vaccination site pain (tenderness)General disorders29/4135/3738/4030/4230/3741/43
Vaccination site painGeneral disorders12/4122/3726/407/4221/3727/43
HeadacheNervous system disorders11/4121/3710/4013/4211/3710/43
FatigueGeneral disorders13/4116/3714/4013/4214/3715/43
MyalgiaMusculoskeletal and connective tissue disorders11/4115/3712/406/429/3711/43
Vaccination site erythemaGeneral disorders8/419/3716/406/427/3712/43
Vaccination site indurationGeneral disorders12/414/3713/406/426/3713/43
MalaiseGeneral disorders9/4111/378/406/428/375/43
PyrexiaGeneral disorders3/414/376/405/425/374/43
White blood cell count decreasedInvestigations6/413/373/402/423/370/43

Baseline characteristics

The baseline analysis population includes all participants that were enrolled.

Age, Categorical
Age, Categorical(Participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
<=18 years0000000
Between 18 and 65 years413740413943241
>=65 years0000000
Age, Continuous
Age, Continuous(years)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
Mean30.7 ± 7.229.6 ± 6.228.2 ± 7.030.2 ± 7.629.7 ± 6.828.7 ± 6.529.5 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
Female222628272326152
Male19111214161789
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
Hispanic or Latino14375323
Not Hispanic or Latino403336343440217
Unknown or Not Reported0010001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
American Indian or Alaska Native0001001
Asian12455522
Native Hawaiian or Other Pacific Islander0000000
Black or African American74278230
White332832262434177
More than one race0221229
Unknown or Not Reported0101002
Region of Enrollment
Region of Enrollment(participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
United States413740413943241
BMI
BMI(kg/m^2)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
Mean26.73 ± 5.3726.87 ± 6.2924.82 ± 4.6426.91 ± 6.5526.25 ± 6.8125.79 ± 5.6726.22 ± 5.91
Prior Seasonal Influenza Vaccination
Prior Seasonal Influenza Vaccination(Participants)FluzoneFluzone + AF03Fluzone + CpG55FlublokFlublok + AF03Flublok + CpG55Total
Either 2017-2018 or 2018-2019362932323036195
Neither 2017-2018 or 2018-201957889744
Unknown0101002
08

Study locations

8 sites
  • Emory University School of Medicine
    Atlanta, Georgia 30322-1014, United States
  • University of Iowa - Vaccine Research and Education Unit
    Iowa City, Iowa 52242-2600, United States
  • University of Maryland Baltimore - School of Medicine - Medicine
    Baltimore, Maryland 21201-1509, United States
  • Saint Louis University Center for Vaccine Development
    St Louis, Missouri 63104-1015, United States
  • Duke Vaccine and Trials Unit
    Durham, North Carolina 27704, United States
  • Cincinnati Children's Hospital Medical Center Vaccine Research Center
    Cincinnati, Ohio 45229-3039, United States
  • Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
    Nashville, Tennessee 37232-2573, United States
  • Baylor College of Medicine
    Houston, Texas 77030-3411, United States
09

References and documents

Publications

  • Hegmann TE, Walter EB, Smith MJ, Campbell J, El Sahly HM, Whitaker JA, Creech CB, Ustyugova IV, Goncalvez AP, Pandey A, Alefantis T, Sridhar S, Honda-Okubo Y, Petrovsky N, Frey SE, Abate G, Paulsen G, Anderson EJ, Rostad CA, Rouphael N, Makhene M, Roberts PC, Tuyishimire B, Bryant C, Winokur P. A phase I study of the safety, reactogenicity and immunogenicity of two quadrivalent seasonal influenza vaccines (Fluzone(R) or Flublok(R)) with or without one of two adjuvants (AF03 or Advax-CpG55.2) in healthy adults 18-45 years of age. Vaccine. 2025 Apr 30;54:126991. doi: 10.1016/j.vaccine.2025.126991. Epub 2025 Mar 18. PubMed 40107003 ↗

Study documents

  • Study protocol · Feb 1, 2021
  • Statistical analysis plan · May 4, 2021
  • Informed consent form · Jun 4, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03945825
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
May 10, 2019
Start date
Jun 10, 2019
Primary completion
Sep 18, 2020
Completion
Sep 18, 2020
Results posted
Jan 3, 2022
Last update
Oct 14, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Start the discussion