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CompletedNCT02921997Updated Oct 9, 2024Results posted

H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses

A Phase 2 interventional study of AS03 and Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 in Avian Influenza, H1N1 Influenza and Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine. The primary objectives are (1) assessing the serum anti-HA hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments performed prior to each study vaccination (Days -7, 1, and 29).

Read the detailed description

This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an intramuscular monovalent inactivated influenza A/H7N9 virus vaccine manufactured by Sanofi Pasteur given with and without AS03 adjuvant manufactured by GlaxoSmithKline, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v virus vaccine manufactured by Sanofi Pasteur. The primary objectives are (1) assessing the serum anti-HA hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments performed prior to each study vaccination (Days -7, 1, and 29). The secondary objectives are: (1) compare plasma cytokine and chemokine profiles at specific time points and between treatment arms at post vaccination points, (2) assess the neutralizing antibody responses to influenza A/H7N9 antigen (with and without adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9 vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one month after the study vaccination with A/H3N2v vaccine), and (3) identify differentially expressed genes in human immune cells on Days 2, 4, and 8 following one intramuscular dose of influenza A/H3N2v vaccine compared to baseline assessments performed prior to study vaccination (Day -7 and Day 1).

02

Conditions studied

  • Avian Influenza
  • H1N1 Influenza
  • Influenza

Keywords

  • A/H5N1
  • A/H7N9
  • ASO3 Adjuvant
  • influenza
  • monovalent
  • pH1N1
  • vaccines
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 30 is below 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 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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. Are males or non-pregnant females, 18 to 49 years old, inclusive.

  4. Are in good health*.

    *As determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, that 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. This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition 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. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, 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 principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.

  5. Oral temperature is less than 100.4 degrees F.
  6. Pulse is 50 to 115 bpm, inclusive.
  7. Systolic blood pressure is 85 to 150 mm Hg, inclusive.
  8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
  9. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour.

  10. Women of childbearing potential* must use an acceptable contraception method** from 30 days before first study vaccination until 60 days after last study vaccination.

    *Not sterilized via tubal ligation, bilateral oophorectomy, 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 of the last menses if menopausal.

    **Includes, but is not limited to, non-male sexual relationships abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").

  11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion criteria

Exclusion Criteria:

  1. Have an acute illness*, as determined by the site principal investigator 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 principal investigator 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 principal investigator or appropriate sub-investigator, is a contraindication to study participation*.

    *Including acute or chronic medical disease or condition, defined as persisting for at least 90 days 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 study.

  3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  4. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy.
  5. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
  6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccines.
  7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines.
  8. Have a personal or family history of narcolepsy.
  9. Have a history of Guillain-Barré syndrome.
  10. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  11. Have a history of a potentially immune-mediated medical condition.
  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.
  14. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 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 >840 mcg/day of beclomethasone dipropionate CFC or equivalent.
  17. Received licensed live vaccine within 30 days prior to the first study vaccination, or plans to receive licensed live vaccine within 30 days before or after each study vaccination.
  18. Received licensed inactivated vaccine within 14 days prior to the first study vaccination, or plans to receive licensed inactivated vaccine within 14 days before or after each study vaccination.
  19. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.

  20. Received an experimental agent* within 30 days prior to the first study vaccination, or expects to receive an experimental agent** during the 13-month study-reporting period.

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

    **Other than from participation in this study.

  21. Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the 13-month study-reporting period.

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

  22. Prior participation in a clinical trial of influenza A/H7 vaccine* or have a history of influenza A/H7 virus actual or potential exposure or infection prior to the first study vaccination.

    *And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients.

  23. Prior participation in a clinical trial of influenza A/H3N2v vaccine* or have a history of influenza A/H3N2v virus actual or potential exposure or infection prior to the first study vaccination.

    *And assigned to a group receiving influenza A/H3N2v vaccine, does not apply to documented placebo recipients.

  24. Occupational exposure to or substantial direct physical contact* with birds in the past year or during the 28 days after each study vaccination.

    *Casual contact with birds at petting zoos or county or state fairs or having pet birds does not exclude subjects from study participation.

  25. Occupational exposure to or substantial direct physical contact* with pigs in the past year or during the 28 days after each study vaccination.

    *Casual contact with pigs at petting zoos or county or state fairs does not exclude subjects from study participation.

  26. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination.
  27. Plan to travel outside the US (continental US, Hawaii, and Alaska) within 28 days after each study vaccination.
  28. Blood donation or planned blood donation within 30 days before enrollment until 30 days after the last blood draw for this study.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Arm 1

    10 Subjects: one dose of 15 µg of A/H3N2v, at Day 1

    Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203

  • Experimental
    Arm 2

    10 Subjects: two doses of 3.75 µg of AH7N9 AS03,at Day 1 and at Day 29

    Drug: AS03 · Biological: Monovalent influenza A/H7N9 virus vaccine

  • Experimental
    Arm 3

    10 Subjects: two doses of 3.75 µg of A/H7N9, at Day 1 and Day 29

    Biological: Monovalent influenza A/H7N9 virus vaccine

Interventions

  • DrugAS03

    AS03 oil-in-water emulsion adjuvant.

  • BiologicalInfluenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203

    Inactivated monovalent subvirion H3N2v vaccine containing hemagglutinin (HA) of A/Minnesota/11/2010 NYMC X-203 virus.

  • BiologicalMonovalent influenza A/H7N9 virus vaccine

    Monovalent influenza A/H7N9 virus vaccine.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)

    Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

    Time frame: Day 29 Post-Vaccination 2 (Day 57)

  2. Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)

    Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.

    Time frame: Day 29 Post-Vaccination 1 (Day 29)

  3. Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)

    RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes , dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints and Day 29 read counts for post-vaccination 2 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).

    Time frame: Days 2, 4, and 29 Post-Vaccination 1 (Day 2, 4, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

Secondary outcomes

  1. Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)

    RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes, dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).

    Time frame: Days 2, 4, and 8 Post-Vaccination 1 (Day 2, 4, and 8, respectively)

  2. Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1

    Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 11 of the total 24 cytokines and chemokines were measured: Fractalkine, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Interferon-Gamma-Induced Protein-10(IP-10), Interferon-Alpha (IFNa), Interferon-Beta (IFNb), Interferon-Gamma (IFNy), Interferon-inducible T Cell Alpha Chemoattractant (ITAC), Interleukin 1 Beta (IL-1b), Interleukin 10 (IL-10), Interleukin 13 (IL-13), and Interleukin 2 (IL-2). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

    Time frame: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

  3. Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2

    Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 9 of the total 24 cytokines and chemokines were measured: Interleukin 21 (IL-21), Interleukin 23 (IL-23), Interleukin 4 (IL-4), Interleukin 5 (IL-5), Interleukin 6 (IL-6), Interleukin 7 (IL-7), Interleukin 8 (IL-8), Interleukin 12, p70 (IL-12p70), and Interleukin 17A (IL-17A). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

    Time frame: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

  4. Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3

    Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 4 of the total 24 cytokines and chemokines were measured: Macrophage Inflammatory Protein-1 Alpha (MIP1a), Macrophage Inflammatory Protein-1 Beta (MIP1b), Macrophage Inflammatory Protein-3 Alpha (MIP3a), and Tumor Necrosis Factor Alpha (TNF-a). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

    Time frame: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

  5. Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1

    Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 7 of the total 24 cytokines and chemokines were measured: Fractalkine, GM-CSF, IP-10, IFNa, IFNb, IFNy, and ITAC. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

    Time frame: Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

  6. Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2

    Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 17 of the total 24 cytokines and chemokines were measured: IL-1b, IL-10, IL-13, IL-2, IL-21, IL-23, IL-4, IL-5, IL-6, IL-7, IL-8, IL-12p70, IL-17A, MIP1a, MIP1b, MIP3a, and TNF-a. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

    Time frame: Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)

  7. Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H7N9 Vaccine, With and Without Adjuvant)

    Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

    Time frame: Day 29 Post-Vaccination 2 (Day 57)

  8. Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H3N2v Vaccine)

    Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.

    Time frame: Day 29 Post-Vaccination 1 (Day 29)

  9. Geometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)

    Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

    Time frame: Day 1 Pre-Vaccination 1, Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)

  10. Geometric Mean Titers of Serum HAI Antibody (A/H3N2v Vaccine)

    Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.

    Time frame: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)

  11. Geometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)

    Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

    Time frame: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)

  12. Geometric Mean Titers of Serum Neut Antibody (A/H3N2v Vaccine)

    Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.

    Time frame: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)

07

Results

Posted Jan 26, 2022

Participant flow

Participants were healthy males and non-pregnant females aged 18 to 49 years old, inclusively. They were recruited from the community at large around the clinic site. Participants were enrolled between 07NOV2016 and 31JAN2017.

Participant flow — Overall Study
MilestoneA/H3N2vA/H7N9 + AS03A/H7N9
Started101010
Completed101010
Not completed000

Outcome measures

PrimaryPercentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)

Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

Time frame:
Day 29 Post-Vaccination 2 (Day 57)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)
percentage of participantsA/H7N9 + AS03A/H7N9
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)80.0 (44.4 to 97.5)0 (0.0 to 30.8)
PrimaryPercentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)

Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.

Time frame:
Day 29 Post-Vaccination 1 (Day 29)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)
percentage of participantsA/H3N2v
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)50 (18.7 to 81.3)
PrimaryNumber of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)

RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes , dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints and Day 29 read counts for post-vaccination 2 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).

Time frame:
Days 2, 4, and 29 Post-Vaccination 1 (Day 2, 4, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Number · Number of DE genes
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Number of DE genesA/H7N9 + AS03A/H7N9
Monocytes : Day 2 Post Vaccination 16180
Monocytes : Day 4 Post Vaccination 1360
Monocytes : Day 29 Post Vaccination 100
Monocytes : Day 2 Post Vaccination 214180
Monocytes : Day 4 Post Vaccination 2260
Monocytes : Day 8 Post Vaccination 240
Dendritic cells : Day 2 Post Vaccination 110910
Dendritic cells : Day 4 Post Vaccination 180
Dendritic cells : Day 29 Post Vaccination 110
Dendritic cells : Day 2 Post Vaccination 219530
Dendritic cells : Day 4 Post Vaccination 2250
Dendritic cells : Day 8 Post Vaccination 21700
Neutrophils : Day 2 Post Vaccination 111160
Neutrophils : Day 4 Post Vaccination 1410
Neutrophils : Day 29 Post Vaccination 100
Neutrophils : Day 2 Post Vaccination 220440
Neutrophils : Day 4 Post Vaccination 21810
Neutrophils : Day 8 Post Vaccination 200
NK cells : Day 2 Post Vaccination 1600
NK cells : Day 4 Post Vaccination 1660
NK cells : Day 29 Post Vaccination 180
NK cells : Day 2 Post Vaccination 23032
NK cells : Day 4 Post Vaccination 23960
NK cells : Day 8 Post Vaccination 21660
B cells : Day 2 Post Vaccination 1510
B cells : Day 4 Post Vaccination 111
B cells : Day 29 Post Vaccination 110
B cells : Day 2 Post Vaccination 23450
B cells : Day 4 Post Vaccination 2990
B cells : Day 8 Post Vaccination 2670
T cells : Day 2 Post Vaccination 1880
T cells : Day 4 Post Vaccination 101
T cells : Day 29 Post Vaccination 110
T cells : Day 2 Post Vaccination 23010
T cells : Day 4 Post Vaccination 230
T cells : Day 8 Post Vaccination 230
SecondaryNumber of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)

RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes, dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).

Time frame:
Days 2, 4, and 8 Post-Vaccination 1 (Day 2, 4, and 8, respectively)
Reported as:
Number · Number of DE genes
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Number of DE genesA/H3N2v
Monocytes : Day 2 Post Vaccination 10
Monocytes : Day 4 Post Vaccination 10
Monocytes : Day 8 Post Vaccination 11
Dendritic cells : Day 2 Post Vaccination 10
Dendritic cells : Day 4 Post Vaccination 10
Dendritic cells : Day 8 Post Vaccination 12
Neutrophils : Day 2 Post Vaccination 10
Neutrophils : Day 4 Post Vaccination 10
Neutrophils : Day 8 Post Vaccination 141
NK cells : Day 2 Post Vaccination 10
NK cells : Day 4 Post Vaccination 10
NK cells : Day 8 Post Vaccination 11
B cells : Day 2 Post Vaccination 10
B cells : Day 4 Post Vaccination 10
B cells : Day 8 Post Vaccination 13
T cells : Day 2 Post Vaccination 10
T cells : Day 4 Post Vaccination 10
T cells : Day 8 Post Vaccination 10
SecondaryCytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1

Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 11 of the total 24 cytokines and chemokines were measured: Fractalkine, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Interferon-Gamma-Induced Protein-10(IP-10), Interferon-Alpha (IFNa), Interferon-Beta (IFNb), Interferon-Gamma (IFNy), Interferon-inducible T Cell Alpha Chemoattractant (ITAC), Interleukin 1 Beta (IL-1b), Interleukin 10 (IL-10), Interleukin 13 (IL-13), and Interleukin 2 (IL-2). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

Time frame:
Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Median · ng/L
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ng/LA/H3N2vA/H7N9 + AS03A/H7N9
Fractalkine : Day 1 Pre-Vaccination310.9 (184.35 to 624.88)288.58 (177.74 to 489.88)356.19 (247.36 to 435.40)
Fractalkine : Day 2 Post-Vaccination 1312.26 (201.01 to 590.01)224.58 (181.26 to 530.97)315.31 (218.69 to 514.56)
Fractalkine : Day 4 Post-Vaccination 1345.14 (218.03 to 567.98)378.46 (172.26 to 543.87)309.48 (212.57 to 494.90)
Fractalkine : Day 8 Post-Vaccination 1370.77 (204.33 to 783.22)——
Fractalkine : Day 29 Post-Vaccination 1—353.48 (210.90 to 492.30)333.38 (265.87 to 450.44)
Fractalkine : Day 2 Post-Vaccination 2—282.53 (178.94 to 566.01)305.83 (235.42 to 476.17)
Fractalkine : Day 4 Post-Vaccination 2—311.15 (223.31 to 466.89)316.25 (235.51 to 461.43)
Fractalkine : Day 8 Post-Vaccination 2—318.38 (178.94 to 486.64)306.53 (209.59 to 449.82)
GM-CSF : Day 1 Pre-Vaccination511.59 (322.67 to 819.37)290.44 (188.18 to 447.68)478.50 (320.57 to 837.17)
GM-CSF : Day 2 Post-Vaccination 1557.77 (354.92 to 783.59)301.31 (195.59 to 423.36)478.66 (327.51 to 713.41)
GM-CSF : Day 4 Post-Vaccination 1561.63 (311.31 to 787.86)286.35 (171.87 to 477.21)448.62 (329.53 to 722.50)
GM-CSF : Day 8 Post-Vaccination 1494.07 (238.89 to 778.82)——
GM-CSF : Day 29 Post-Vaccination 1—324.61 (192.61 to 392.17)476.40 (315.83 to 832.99)
GM-CSF : Day 2 Post-Vaccination 2—313.25 (225.34 to 442.63)497.90 (301.38 to 809.71)
GM-CSF : Day 4 Post-Vaccination 2—259.34 (210.99 to 385.57)468.16 (344.33 to 920.82)
GM-CSF : Day 8 Post-Vaccination 2—276.04 (195.20 to 452.95)468.95 (330.08 to 612.07)
IP-10 : Day 1 Pre-Vaccination249.16 (209.78 to 360.45)288.09 (194.27 to 444.35)238.80 (157.18 to 324.89)
IP-10 : Day 2 Post-Vaccination 1261.78 (229.52 to 621.71)535.80 (372.78 to 709.82)273.48 (137.01 to 362.69)
IP-10 : Day 4 Post-Vaccination 1242.77 (198.72 to 376.06)417.82 (263.11 to 560.03)219.79 (161.22 to 381.36)
IP-10 : Day 8 Post-Vaccination 1236.95 (175.75 to 315.67)——
IP-10 : Day 29 Post-Vaccination 1—284.62 (200.09 to 367.84)212.26 (144.78 to 259.60)
IP-10 : Day 2 Post-Vaccination 2—1264.00 (586.12 to 2541.12)234.75 (134.66 to 311.02)
IP-10 : Day 4 Post-Vaccination 2—512.16 (339.91 to 567.27)224.40 (154.65 to 322.71)
IP-10 : Day 8 Post-Vaccination 2—307.23 (227.78 to 373.61)220.60 (127.68 to 280.31)
IFNa : Day 1 Pre-Vaccination116.80 (58.27 to 149.96)142.43 (91.50 to 213.19)104.81 (64.58 to 152.56)
IFNa : Day 2 Post-Vaccination 173.98 (62.82 to 155.25)132.03 (91.88 to 179.71)101.40 (38.58 to 232.97)
IFNa : Day 4 Post-Vaccination 166.93 (30.39 to 191.17)125.29 (87.21 to 251.48)86.82 (29.60 to 181.88)
IFNa : Day 8 Post-Vaccination 189.29 (51.11 to 153.41)——
IFNa : Day 29 Post-Vaccination 1—118.90 (79.39 to 218.86)111.00 (53.91 to 149.95)
IFNa : Day 2 Post-Vaccination 2—130.25 (97.22 to 213.06)89.99 (38.72 to 161.13)
IFNa : Day 4 Post-Vaccination 2—127.23 (93.43 to 231.92)113.26 (51.80 to 225.69)
IFNa : Day 8 Post-Vaccination 2—163.86 (102.50 to 219.70)89.00 (26.83 to 168.33)
IFNb : Day 1 Pre-Vaccination1073.70 (856.91 to 1843.25)1211.25 (743.26 to 1686.50)989.57 (760.70 to 1818.92)
IFNb : Day 2 Post-Vaccination 11023.11 (732.33 to 1286.00)1068.38 (708.26 to 1620.50)1106.50 (657.21 to 1516.84)
IFNb : Day 4 Post-Vaccination 1878.76 (735.36 to 1534.50)1074.52 (739.07 to 1730.00)1045.50 (867.77 to 1768.00)
IFNb : Day 8 Post-Vaccination 11104.00 (718.50 to 1564.00)——
IFNb : Day 29 Post-Vaccination 1—1185.00 (598.46 to 1407.50)1109.00 (684.26 to 2134.00)
IFNb : Day 2 Post-Vaccination 2—1188.50 (734.74 to 1757.00)1241.50 (624.16 to 1883.74)
IFNb : Day 4 Post-Vaccination 2—1027.74 (649.67 to 1760.00)980.99 (776.21 to 1564.00)
IFNb : Day 8 Post-Vaccination 2—992.82 (647.85 to 1671.50)1326.50 (776.40 to 1521.25)
IFNy : Day 1 Pre-Vaccination28.71 (13.21 to 46.65)17.86 (11.28 to 43.92)33.82 (22.85 to 45.92)
IFNy : Day 2 Post-Vaccination 126.47 (12.49 to 54.72)21.22 (13.01 to 47.81)33.17 (22.11 to 46.45)
IFNy : Day 4 Post-Vaccination 126.38 (14.20 to 50.92)19.01 (9.02 to 47.74)33.74 (22.81 to 41.58)
IFNy : Day 8 Post-Vaccination 130.98 (13.45 to 48.70)——
IFNy : Day 29 Post-Vaccination 1—23.07 (11.57 to 49.17)32.43 (25.74 to 39.04)
IFNy : Day 2 Post-Vaccination 2—37.22 (23.07 to 59.78)30.79 (25.01 to 36.40)
IFNy : Day 4 Post-Vaccination 2—19.99 (10.90 to 41.65)29.70 (22.16 to 39.11)
IFNy : Day 8 Post-Vaccination 2—18.00 (11.37 to 46.89)28.94 (21.79 to 36.99)
ITAC : Day 1 Pre-Vaccination58.19 (27.49 to 140.69)44.19 (30.64 to 76.83)52.62 (26.89 to 89.05)
ITAC : Day 2 Post-Vaccination 156.31 (27.66 to 152.10)52.46 (35.90 to 90.02)49.22 (30.06 to 75.22)
ITAC : Day 4 Post-Vaccination 151.68 (23.65 to 188.54)47.38 (36.63 to 84.94)52.83 (24.25 to 69.46)
ITAC : Day 8 Post-Vaccination 149.21 (20.12 to 205.30)——
ITAC : Day 29 Post-Vaccination 1—60.62 (23.95 to 86.14)49.58 (24.37 to 68.83)
ITAC : Day 2 Post-Vaccination 2—77.16 (48.46 to 191.11)45.04 (23.91 to 68.24)
ITAC : Day 4 Post-Vaccination 2—58.32 (31.86 to 83.67)34.97 (24.36 to 59.44)
ITAC : Day 8 Post-Vaccination 2—50.94 (36.37 to 84.45)47.67 (28.41 to 76.88)
IL-1b : Day 1 Pre-Vaccination2.84 (1.75 to 4.74)2.83 (1.43 to 5.08)3.33 (2.10 to 6.93)
IL-1b : Day 2 Post-Vaccination 12.62 (1.68 to 4.57)2.33 (1.30 to 5.28)3.46 (2.22 to 7.00)
IL-1b : Day 4 Post-Vaccination 12.78 (1.81 to 4.46)3.46 (1.34 to 5.80)3.39 (2.08 to 5.58)
IL-1b : Day 8 Post-Vaccination 12.82 (1.78 to 5.41)——
IL-1b : Day 29 Post-Vaccination 1—3.25 (1.67 to 5.49)3.70 (2.25 to 5.03)
IL-1b : Day 2 Post-Vaccination 2—2.99 (1.37 to 7.12)3.88 (2.12 to 5.63)
IL-1b : Day 4 Post-Vaccination 2—2.81 (1.49 to 4.93)3.16 (2.25 to 6.93)
IL-1b : Day 8 Post-Vaccination 2—2.52 (1.59 to 7.03)3.03 (2.15 to 5.20)
IL-10 : Day 1 Pre-Vaccination21.92 (9.32 to 59.45)18.28 (10.29 to 37.48)27.67 (19.96 to 40.21)
IL-10 : Day 2 Post-Vaccination 122.26 (10.43 to 65.61)17.16 (13.04 to 38.18)26.04 (21.00 to 36.63)
IL-10 : Day 4 Post-Vaccination 122.29 (15.03 to 72.99)17.64 (12.84 to 39.04)29.53 (20.68 to 41.65)
IL-10 : Day 8 Post-Vaccination 119.52 (12.57 to 105.24)——
IL-10 : Day 29 Post-Vaccination 1—19.93 (12.35 to 38.28)26.71 (21.28 to 36.63)
IL-10 : Day 2 Post-Vaccination 2—23.79 (11.07 to 44.81)24.57 (17.44 to 35.06)
IL-10 : Day 4 Post-Vaccination 2—19.29 (14.95 to 36.55)26.39 (17.73 to 38.52)
IL-10 : Day 8 Post-Vaccination 2—21.75 (12.06 to 35.99)23.29 (19.25 to 31.83)
IL-13 : Day 1 Pre-Vaccination11.24 (6.18 to 33.79)18.39 (8.41 to 28.27)12.46 (8.35 to 21.16)
IL-13 : Day 2 Post-Vaccination 110.98 (6.97 to 39.49)20.66 (8.93 to 25.85)11.72 (8.01 to 23.73)
IL-13 : Day 4 Post-Vaccination 113.86 (6.33 to 39.49)21.10 (9.03 to 25.98)11.51 (7.94 to 22.80)
IL-13 : Day 8 Post-Vaccination 111.02 (5.48 to 61.06)——
IL-13 : Day 29 Post-Vaccination 1—19.35 (10.85 to 33.12)10.80 (5.79 to 21.52)
IL-13 : Day 2 Post-Vaccination 2—18.99 (9.84 to 36.55)10.79 (6.40 to 20.43)
IL-13 : Day 4 Post-Vaccination 2—17.56 (11.01 to 35.15)10.08 (6.55 to 20.46)
IL-13 : Day 8 Post-Vaccination 2—21.50 (8.16 to 39.16)10.36 (7.25 to 21.45)
IL-2 : Day 1 Pre-Vaccination3.30 (2.02 to 6.67)2.49 (1.33 to 6.58)4.48 (2.73 to 8.18)
IL-2 : Day 2 Post-Vaccination 14.13 (1.94 to 6.52)2.52 (1.20 to 6.57)4.32 (2.77 to 8.76)
IL-2 : Day 4 Post-Vaccination 13.43 (2.03 to 6.49)2.28 (1.74 to 7.00)3.82 (2.98 to 7.79)
IL-2 : Day 8 Post-Vaccination 12.99 (2.62 to 7.74)——
IL-2 : Day 29 Post-Vaccination 1—2.29 (1.77 to 7.40)4.68 (3.08 to 6.97)
IL-2 : Day 2 Post-Vaccination 2—2.39 (1.17 to 8.47)4.05 (2.64 to 8.21)
IL-2 : Day 4 Post-Vaccination 2—2.71 (1.46 to 6.85)3.74 (2.69 to 9.81)
IL-2 : Day 8 Post-Vaccination 2—3.14 (1.70 to 6.84)3.97 (2.69 to 6.22)
SecondaryCytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2

Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 9 of the total 24 cytokines and chemokines were measured: Interleukin 21 (IL-21), Interleukin 23 (IL-23), Interleukin 4 (IL-4), Interleukin 5 (IL-5), Interleukin 6 (IL-6), Interleukin 7 (IL-7), Interleukin 8 (IL-8), Interleukin 12, p70 (IL-12p70), and Interleukin 17A (IL-17A). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

Time frame:
Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Median · ng/L
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
ng/LA/H3N2vA/H7N9 + AS03A/H7N9
IL-21 : Day 1 Pre-Vaccination3.54 (1.39 to 9.12)3.25 (1.64 to 4.33)2.43 (1.66 to 10.32)
IL-21 : Day 2 Post-Vaccination 13.83 (1.56 to 10.25)3.00 (1.76 to 5.34)2.63 (1.76 to 9.32)
IL-21 : Day 4 Post-Vaccination 14.47 (1.92 to 11.57)2.76 (1.90 to 5.22)2.64 (1.76 to 9.26)
IL-21 : Day 8 Post-Vaccination 12.76 (1.12 to 15.81)——
IL-21 : Day 29 Post-Vaccination 1—4.76 (1.90 to 5.77)2.53 (1.73 to 9.57)
IL-21 : Day 2 Post-Vaccination 2—4.29 (2.13 to 6.54)2.09 (1.38 to 9.30)
IL-21 : Day 4 Post-Vaccination 2—3.96 (1.96 to 5.91)2.01 (1.59 to 10.27)
IL-21 : Day 8 Post-Vaccination 2—2.85 (1.84 to 6.78)1.93 (1.71 to 7.32)
IL-23 : Day 1 Pre-Vaccination367.05 (245.03 to 565.32)368.23 (280.19 to 527.92)550.19 (340.63 to 750.07)
IL-23 : Day 2 Post-Vaccination 1304.56 (213.42 to 482.68)362.33 (199.20 to 495.74)490.16 (336.64 to 807.72)
IL-23 : Day 4 Post-Vaccination 1419.28 (222.30 to 569.42)468.30 (246.74 to 605.22)583.59 (328.03 to 786.52)
IL-23 : Day 8 Post-Vaccination 1339.06 (256.69 to 555.18)——
IL-23 : Day 29 Post-Vaccination 1—418.57 (311.36 to 548.07)496.08 (317.22 to 918.63)
IL-23 : Day 2 Post-Vaccination 2—487.09 (312.55 to 758.84)536.87 (345.26 to 768.30)
IL-23 : Day 4 Post-Vaccination 2—409.82 (319.81 to 524.89)514.30 (310.06 to 768.41)
IL-23 : Day 8 Post-Vaccination 2—421.69 (326.56 to 622.45)444.43 (341.61 to 916.35)
IL-4 : Day 1 Pre-Vaccination61.67 (48.37 to 103.08)49.85 (39.70 to 119.83)59.30 (46.83 to 154.39)
IL-4 : Day 2 Post-Vaccination 169.57 (43.44 to 105.29)53.00 (36.30 to 123.64)63.35 (45.19 to 188.85)
IL-4 : Day 4 Post-Vaccination 168.54 (50.44 to 91.18)53.75 (37.06 to 128.56)58.21 (41.52 to 150.14)
IL-4 : Day 8 Post-Vaccination 163.89 (41.87 to 106.36)——
IL-4 : Day 29 Post-Vaccination 1—59.46 (42.24 to 132.19)59.83 (41.62 to 158.67)
IL-4 : Day 2 Post-Vaccination 2—66.66 (33.95 to 135.48)61.47 (38.94 to 136.29)
IL-4 : Day 4 Post-Vaccination 2—67.74 (35.01 to 121.38)59.86 (40.82 to 167.25)
IL-4 : Day 8 Post-Vaccination 2—54.44 (39.43 to 159.90)63.96 (37.41 to 122.34)
IL-5 : Day 1 Pre-Vaccination3.22 (1.54 to 6.26)3.92 (2.46 to 5.98)2.82 (2.16 to 7.27)
IL-5 : Day 2 Post-Vaccination 13.04 (1.55 to 7.85)4.54 (2.46 to 5.53)2.84 (2.12 to 6.93)
IL-5 : Day 4 Post-Vaccination 12.96 (1.45 to 7.93)4.73 (2.90 to 6.04)3.03 (1.79 to 8.55)
IL-5 : Day 8 Post-Vaccination 12.50 (1.66 to 9.71)——
IL-5 : Day 29 Post-Vaccination 1—4.56 (2.35 to 7.50)3.33 (2.08 to 6.96)
IL-5 : Day 2 Post-Vaccination 2—4.83 (2.75 to 9.01)3.03 (1.88 to 6.98)
IL-5 : Day 4 Post-Vaccination 2—4.15 (2.56 to 7.36)3.04 (2.17 to 7.92)
IL-5 : Day 8 Post-Vaccination 2—4.78 (2.63 to 7.19)3.25 (1.77 to 6.43)
IL-6 : Day 1 Pre-Vaccination2.02 (1.19 to 4.09)1.26 (0.86 to 5.33)3.39 (2.15 to 5.62)
IL-6 : Day 2 Post-Vaccination 12.03 (1.30 to 5.00)2.54 (1.73 to 6.08)3.23 (2.17 to 6.54)
IL-6 : Day 4 Post-Vaccination 12.09 (1.21 to 5.42)1.48 (0.72 to 4.23)3.39 (2.25 to 6.85)
IL-6 : Day 8 Post-Vaccination 12.28 (0.75 to 4.52)——
IL-6 : Day 29 Post-Vaccination 1—1.75 (0.98 to 3.60)3.52 (2.33 to 4.60)
IL-6 : Day 2 Post-Vaccination 2—2.95 (2.20 to 4.60)3.09 (2.22 to 4.95)
IL-6 : Day 4 Post-Vaccination 2—1.48 (0.99 to 3.31)3.06 (2.21 to 4.92)
IL-6 : Day 8 Post-Vaccination 2—1.07 (0.71 to 3.33)3.11 (1.80 to 4.28)
IL-7 : Day 1 Pre-Vaccination4.02 (2.50 to 8.88)4.58 (2.27 to 10.37)5.22 (3.62 to 10.88)
IL-7 : Day 2 Post-Vaccination 13.90 (2.72 to 9.67)4.05 (1.75 to 11.04)5.12 (4.00 to 10.56)
IL-7 : Day 4 Post-Vaccination 13.71 (2.35 to 6.81)4.93 (1.75 to 11.18)4.97 (3.37 to 12.30)
IL-7 : Day 8 Post-Vaccination 13.89 (3.00 to 14.78)——
IL-7 : Day 29 Post-Vaccination 1—5.85 (2.19 to 10.39)4.99 (4.06 to 9.92)
IL-7 : Day 2 Post-Vaccination 2—6.20 (2.27 to 11.20)4.41 (3.44 to 9.50)
IL-7 : Day 4 Post-Vaccination 2—5.56 (1.76 to 9.02)4.83 (3.04 to 9.12)
IL-7 : Day 8 Post-Vaccination 2—5.46 (2.66 to 12.88)4.03 (3.13 to 9.96)
IL-8 : Day 1 Pre-Vaccination4.37 (3.27 to 28.92)6.97 (3.31 to 9.79)5.53 (3.26 to 10.62)
IL-8 : Day 2 Post-Vaccination 15.04 (4.03 to 16.04)6.76 (3.32 to 9.22)5.04 (3.14 to 10.18)
IL-8 : Day 4 Post-Vaccination 14.86 (3.80 to 16.79)7.47 (3.11 to 10.11)5.33 (3.58 to 9.75)
IL-8 : Day 8 Post-Vaccination 14.35 (3.50 to 24.83)——
IL-8 : Day 29 Post-Vaccination 1—7.42 (2.90 to 9.27)4.53 (3.29 to 9.51)
IL-8 : Day 2 Post-Vaccination 2—8.41 (2.73 to 12.62)4.84 (3.16 to 8.89)
IL-8 : Day 4 Post-Vaccination 2—7.03 (2.11 to 10.18)4.70 (2.93 to 8.43)
IL-8 : Day 8 Post-Vaccination 2—5.64 (2.98 to 11.70)4.44 (3.06 to 9.07)
IL-12p70 : Day 1 Pre-Vaccination3.96 (1.67 to 7.55)2.53 (1.36 to 6.09)5.33 (1.82 to 9.53)
IL-12p70 : Day 2 Post-Vaccination 13.93 (2.04 to 7.59)2.50 (1.40 to 6.32)4.18 (1.48 to 11.06)
IL-12p70 : Day 4 Post-Vaccination 13.95 (1.88 to 7.66)2.68 (1.70 to 6.27)4.90 (2.05 to 9.85)
IL-12p70 : Day 8 Post-Vaccination 14.63 (1.81 to 8.22)——
IL-12p70 : Day 29 Post-Vaccination 1—3.65 (1.46 to 6.80)5.63 (1.64 to 7.53)
IL-12p70 : Day 2 Post-Vaccination 2—3.83 (1.34 to 8.87)5.01 (1.84 to 7.65)
IL-12p70 : Day 4 Post-Vaccination 2—3.69 (1.74 to 5.58)4.44 (2.33 to 8.64)
IL-12p70 : Day 8 Post-Vaccination 2—2.18 (1.66 to 7.71)5.08 (1.67 to 8.29)
IL-17A: Day 1 Pre-Vaccination19.44 (11.52 to 26.02)14.04 (9.60 to 33.02)24.34 (18.45 to 39.84)
IL-17A : Day 2 Post-Vaccination 118.06 (11.27 to 29.38)15.12 (8.00 to 36.45)20.96 (16.61 to 38.07)
IL-17A : Day 4 Post-Vaccination 120.03 (11.40 to 34.12)14.86 (9.26 to 35.99)22.84 (16.82 to 34.56)
IL-17A : Day 8 Post-Vaccination 122.21 (11.47 to 33.23)——
IL-17A : Day 29 Post-Vaccination 1—17.44 (9.81 to 37.00)23.83 (20.33 to 30.67)
IL-17A : Day 2 Post-Vaccination 2—18.69 (8.98 to 35.80)23.50 (18.52 to 30.20)
IL-17A : Day 4 Post-Vaccination 2—16.66 (9.39 to 32.65)21.67 (18.70 to 34.83)
IL-17A : Day 8 Post-Vaccination 2—13.24 (10.13 to 27.27)21.34 (16.22 to 30.88)
SecondaryCytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3

Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 4 of the total 24 cytokines and chemokines were measured: Macrophage Inflammatory Protein-1 Alpha (MIP1a), Macrophage Inflammatory Protein-1 Beta (MIP1b), Macrophage Inflammatory Protein-3 Alpha (MIP3a), and Tumor Necrosis Factor Alpha (TNF-a). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

Time frame:
Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Median · ng/L
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
ng/LA/H3N2vA/H7N9 + AS03A/H7N9
MIP1a : Day 1 Pre-Vaccination25.49 (15.16 to 42.51)24.86 (17.98 to 38.64)22.98 (18.00 to 41.08)
MIP1a : Day 2 Post-Vaccination 124.56 (14.79 to 43.50)24.96 (17.78 to 40.41)23.13 (16.62 to 45.80)
MIP1a : Day 4 Post-Vaccination 123.86 (15.07 to 50.72)24.44 (19.50 to 37.41)22.34 (18.16 to 46.99)
MIP1a : Day 8 Post-Vaccination 127.64 (16.04 to 54.73)——
MIP1a : Day 29 Post-Vaccination 1—26.08 (18.52 to 36.89)23.09 (17.91 to 43.35)
MIP1a : Day 2 Post-Vaccination 2—29.90 (22.66 to 39.17)21.25 (18.28 to 43.92)
MIP1a : Day 4 Post-Vaccination 2—24.08 (17.70 to 38.31)23.44 (17.45 to 44.09)
MIP1a : Day 8 Post-Vaccination 2—33.32 (15.40 to 41.68)22.54 (15.73 to 42.55)
MIP1b : Day 1 Pre-Vaccination18.63 (15.69 to 31.89)12.99 (10.99 to 27.31)20.33 (14.53 to 36.98)
MIP1b : Day 2 Post-Vaccination 120.43 (17.90 to 31.63)16.90 (12.06 to 33.56)19.84 (13.91 to 34.72)
MIP1b : Day 4 Post-Vaccination 120.47 (16.69 to 27.61)14.76 (10.77 to 33.98)19.16 (15.58 to 40.36)
MIP1b : Day 8 Post-Vaccination 123.67 (16.79 to 37.81)——
MIP1b : Day 29 Post-Vaccination 1—16.05 (9.66 to 28.29)18.35 (12.76 to 35.12)
MIP1b : Day 2 Post-Vaccination 2—29.05 (18.38 to 40.59)16.78 (13.36 to 32.55)
MIP1b : Day 4 Post-Vaccination 2—14.42 (10.92 to 23.29)17.56 (14.29 to 36.42)
MIP1b : Day 8 Post-Vaccination 2—16.18 (10.86 to 28.51)16.18 (14.61 to 32.97)
MIP3a : Day 1 Pre-Vaccination16.77 (11.10 to 32.16)15.34 (9.87 to 29.55)16.60 (12.26 to 33.44)
MIP3a : Day 2 Post-Vaccination 119.59 (11.39 to 24.35)13.90 (8.92 to 25.28)15.44 (13.38 to 32.35)
MIP3a : Day 4 Post-Vaccination 118.58 (10.93 to 27.55)16.49 (8.94 to 24.60)15.74 (14.29 to 29.96)
MIP3a : Day 8 Post-Vaccination 118.62 (13.23 to 34.32)——
MIP3a : Day 29 Post-Vaccination 1—15.72 (11.19 to 27.29)16.05 (12.70 to 34.47)
MIP3a : Day 2 Post-Vaccination 2—16.24 (11.39 to 25.25)14.27 (11.30 to 31.88)
MIP3a : Day 4 Post-Vaccination 2—16.24 (10.71 to 22.28)15.31 (12.46 to 40.70)
MIP3a : Day 8 Post-Vaccination 2—19.01 (10.22 to 28.61)14.53 (12.18 to 50.55)
TNF-a : Day 1 Pre-Vaccination4.32 (3.64 to 8.29)4.18 (2.66 to 7.11)5.36 (3.85 to 9.95)
TNF-a : Day 2 Post-Vaccination 15.13 (3.75 to 8.30)4.26 (3.18 to 8.59)5.40 (3.32 to 10.16)
TNF-a : Day 4 Post-Vaccination 15.16 (4.02 to 7.83)4.78 (3.21 to 9.07)5.24 (4.09 to 12.87)
TNF-a : Day 8 Post-Vaccination 14.48 (3.52 to 9.02)——
TNF-a : Day 29 Post-Vaccination 1—4.88 (2.95 to 8.00)4.93 (3.20 to 10.11)
TNF-a : Day 2 Post-Vaccination 2—8.13 (5.61 to 11.90)4.78 (3.19 to 9.54)
TNF-a : Day 4 Post-Vaccination 2—5.28 (3.34 to 7.34)5.26 (3.03 to 11.05)
TNF-a : Day 8 Post-Vaccination 2—4.56 (3.85 to 7.69)4.54 (3.23 to 9.62)
SecondaryFold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1

Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 7 of the total 24 cytokines and chemokines were measured: Fractalkine, GM-CSF, IP-10, IFNa, IFNb, IFNy, and ITAC. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

Time frame:
Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Median · fold change
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
fold changeA/H3N2vA/H7N9 + AS03A/H7N9
Fractalkine : Day 2 Post-Vaccination 10.944 (0.850 to 1.170)1.015 (0.830 to 1.080)1.003 (0.870 to 1.070)
Fractalkine : Day 4 Post-Vaccination 11.024 (0.910 to 1.350)1.092 (0.890 to 1.470)0.946 (.840 to 1.140)
Fractalkine : Day 8 Post-Vaccination 10.983 (0.920 to 1.160)——
Fractalkine : Day 29 Post-Vaccination 1—0.999 (0.900 to 1.240)1.063 (0.860 to 1.080)
Fractalkine : Day 2 Post-Vaccination 2—1.010 (0.860 to 1.300)1.053 (0.880 to 1.100)
Fractalkine : Day 4 Post-Vaccination 2—1.022 (0.800 to 1.130)1.010 (0.840 to 1.290)
Fractalkine : Day 8 Post-Vaccination 2—0.931 (.770 to 1.250)0.985 (0.880 to 1.100)
GM-CSF : Day 2 Post-Vaccination 11.117 (1.00 to 1.220)1.020 (0.890 to 1.070)0.971 (0.920 to 1.090)
GM-CSF : Day 4 Post-Vaccination 11.096 (0.960 to 1.200)0.932 (0.850 to 1.170)0.971 (0.860 to 1.100)
GM-CSF : Day 8 Post-Vaccination 11.043 (0.970 to 1.200)——
GM-CSF : Day 29 Post-Vaccination 1—1.053 (0.860 to 1.280)1.018 (0.960 to 1.070)
GM-CSF : Day 2 Post-Vaccination 2—1.107 (0.940 to 1.210)0.994 (0.900 to 1.060)
GM-CSF : Day 4 Post-Vaccination 2—0.832 (0.770 to 1.040)1.004 (0.900 to 1.170)
GM-CSF : Day 8 Post-Vaccination 2—1.053 (0.770 to 1.210)0.969 (0.900 to 1.010)
IP-10 : Day 2 Post-Vaccination 10.988 (0.870 to 1.250)1.867 (0.990 to 2.740)1.065 (0.910 to 1.190)
IP-10 : Day 4 Post-Vaccination 10.983 (0.760 to 1.090)1.445 (0.750 to 1.810)0.977 (0.850 to 1.150)
IP-10 : Day 8 Post-Vaccination 10.889 (0.650 to 0.960)——
IP-10 : Day 29 Post-Vaccination 1—0.869 (0.720 to 1.140)0.868 (0.780 to 0.930)
IP-10 : Day 2 Post-Vaccination 2—4.461 (2.190 to 8.260)1.097 (1.030 to 1.340)
IP-10 : Day 4 Post-Vaccination 2—1.450 (1.160 to 1.930)1.111 (0.970 to 1.340)
IP-10 : Day 8 Post-Vaccination 2—1.002 (0.850 to 1.060)1.022 (0.910 to 1.250)
IFNa : Day 2 Post-Vaccination 10.830 (0.620 to 1.090)0.959 (0.790 to 1.130)1.207 (0.600 to 2.040)
IFNa : Day 4 Post-Vaccination 10.807 (0.380 to 1.250)1.023 (0.840 to 1.270)1.121 (0.470 to 1.270)
IFNa : Day 8 Post-Vaccination 10.877 (0.550 to 1.300)——
IFNa : Day 29 Post-Vaccination 1—0.969 (0.640 to 1.260)0.924 (0.700 to 0.980)
IFNa : Day 2 Post-Vaccination 2—1.091 (0.870 to 1.730)0.964 (0.700 to 1.180)
IFNa : Day 4 Post-Vaccination 2—1.079 (0.780 to 1.480)1.252 (0.500 to 1.670)
IFNa : Day 8 Post-Vaccination 2—1.164 (0.930 to 1.520)0.906 (0.470 to 1.300)
IFNb : Day 2 Post-Vaccination 10.907 (0.700 to 1.170)0.929 (0.750 to 1.360)0.839 (0.760 to 1.110)
IFNb : Day 4 Post-Vaccination 10.941 (0.760 to 1.150)1.134 (0.850 to 1.450)1.092 (0.760 to 1.270)
IFNb : Day 8 Post-Vaccination 11.000 (0.830 to 1.220)——
IFNb : Day 29 Post-Vaccination 1—0.858 (0.670 to 1.060)0.968 (0.880 to 1.260)
IFNb : Day 2 Post-Vaccination 2—1.172 (1.050 to 1.740)0.989 (0.810 to 1.200)
IFNb : Day 4 Post-Vaccination 2—1.051 (1.000 to 1.200)1.033 (0.820 to 1.170)
IFNb : Day 8 Post-Vaccination 2—1.249 (1.000 to 1.530)1.074 (0.740 to 1.280)
IFNy : Day 2 Post-Vaccination 10.993 (0.940 to 1.160)1.118 (1.020 to 1.570)0.987 (0.910 to 1.030)
IFNy : Day 4 Post-Vaccination 11.049 (0.940 to 1.140)1.018 (0.870 to 1.110)0.991 (0.930 to 1.020)
IFNy : Day 8 Post-Vaccination 11.018 (0.940 to 1.090)——
IFNy : Day 29 Post-Vaccination 1—1.085 (0.930 to 1.190)0.958 (0.840 to 1.180)
IFNy : Day 2 Post-Vaccination 2—1.819 (1.070 to 2.500)0.968 (0.930 to 1.030)
IFNy : Day 4 Post-Vaccination 2—0.854 (0.770 to 0.960)0.927 (0.870 to 1.110)
IFNy : Day 8 Post-Vaccination 2—0.973 (0.800 to 1.070)0.927 (0.850 to 1.010)
ITAC : Day 2 Post-Vaccination 10.975 (0.870 to 1.220)1.149 (0.980 to 1.290)0.926 (0.800 to 1.270)
ITAC : Day 4 Post-Vaccination 11.020 (0.860 to 1.360)1.160 (0.990 to 1.260)0.953 (0.750 to 1.170)
ITAC : Day 8 Post-Vaccination 10.874 (0.610 to 1.460)——
ITAC : Day 29 Post-Vaccination 1—0.895 (0.810 to 1.070)0.913 (0.760 to 0.980)
ITAC : Day 2 Post-Vaccination 2—2.277 (1.350 to 3.660)0.916 (0.840 to 0.990)
ITAC : Day 4 Post-Vaccination 2—1.098 (0.900 to 1.260)0.852 (0.660 to 1.210)
ITAC : Day 8 Post-Vaccination 2—1.325 (0.800 to 2.190)1.041 (0.910 to 1.210)
SecondaryFold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2

Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 17 of the total 24 cytokines and chemokines were measured: IL-1b, IL-10, IL-13, IL-2, IL-21, IL-23, IL-4, IL-5, IL-6, IL-7, IL-8, IL-12p70, IL-17A, MIP1a, MIP1b, MIP3a, and TNF-a. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.

Time frame:
Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)
Reported as:
Median · fold change
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
fold changeA/H3N2vA/H7N9 + AS03A/H7N9
IL-1b : Day 2 Post-Vaccination 10.981 (0.840 to 1.150)0.933 (0.860 to 1.070)0.950 (0.880 to 1.160)
IL-1b : Day 4 Post-Vaccination 11.050 (0.900 to 1.210)1.004 (0.830 to 1.280)0.996 (0.800 to 1.120)
IL-1b : Day 8 Post-Vaccination 10.989 (0.850 to 1.080)——
IL-1b : Day 29 Post-Vaccination 1—1.022 (0.980 to 1.280)0.938 (0.800 to 1.120)
IL-1b : Day 2 Post-Vaccination 2—0.942 (0.810 to 1.340)0.940 (0.890 to 1.190)
IL-1b : Day 4 Post-Vaccination 2—0.890 (0.780 to 1.020)1.044 (0.860 to 1.220)
IL-1b : Day 8 Post-Vaccination 2—1.106 (0.780 to 1.280)0.957 (0.810 to 1.070)
IL-10 : Day 2 Post-Vaccination 11.106 (0.900 to 1.210)1.028 (0.870 to 1.190)0.975 (0.840 to 1.120)
IL-10 : Day 4 Post-Vaccination 11.043 (0.920 to 1.300)1.118 (0.950 to 1.250)1.003 (0.810 to 1.160)
IL-10 : Day 8 Post-Vaccination 10.979 (0.810 to 1.120)——
IL-10 : Day 29 Post-Vaccination 1—1.076 (0.960 to 1.500)1.032 (0.790 to 1.180)
IL-10 : Day 2 Post-Vaccination 2—1.099 (0.910 to 1.290)0.919 (0.850 to 0.980)
IL-10 : Day 4 Post-Vaccination 2—0.950 (0.840 to 1.130)0.962 (0.770 to 1.150)
IL-10 : Day 8 Post-Vaccination 2—0.979 (0.830 to 1.210)0.875 (0.760 to 1.010)
IL-13 : Day 2 Post-Vaccination 11.021 (0.940 to 1.090)1.024 (0.910 to 1.100)0.982 (0.830 to 1.170)
IL-13 : Day 4 Post-Vaccination 11.059 (0.970 to 1.180)0.988 (0.950 to 1.070)0.994 (0.870 to 1.050)
IL-13 : Day 8 Post-Vaccination 11.065 (0.880 to 1.110)——
IL-13 : Day 29 Post-Vaccination 1—1.074 (0.840 to 1.420)0.990 (0.890 to 1.190)
IL-13 : Day 2 Post-Vaccination 2—0.973 (0.900 to 1.050)0.988 (0.910 to 1.030)
IL-13 : Day 4 Post-Vaccination 2—0.979 (0.820 to 1.230)0.976 (0.900 to 1.010)
IL-13 : Day 8 Post-Vaccination 2—1.013 (0.770 to 1.130)0.975 (0.890 to 1.040)
IL-2 : Day 2 Post-Vaccination 11.055 (0.960 to 1.280)0.994 (0.960 to 1.030)0.964 (0.860 to 1.070)
IL-2 : Day 4 Post-Vaccination 11.020 (0.890 to 1.210)1.024 (0.910 to 1.240)0.908 (0.850 to 1.110)
IL-2 : Day 8 Post-Vaccination 11.080 (0.760 to 1.090)——
IL-2 : Day 29 Post-Vaccination 1—1.119 (0.860 to 1.850)0.997 (0.710 to 1.140)
IL-2 : Day 2 Post-Vaccination 2—1.059 (0.680 to 1.170)0.901 (0.830 to 1.030)
IL-2 : Day 4 Post-Vaccination 2—0.907 (0.690 to 1.090)1.023 (0.780 to 1.160)
IL-2 : Day 8 Post-Vaccination 2—1.031 (0.740 to 1.280)0.927 (0.840 to 0.970)
IL-21 : Day 2 Post-Vaccination 11.152 (0.930 to 1.420)0.992 (0.850 to 1.150)0.932 (0.850 to 1.210)
IL-21 : Day 4 Post-Vaccination 11.402 (0.920 to 1.550)0.959 (0.790 to 1.260)0.902 (0.840 to 1.070)
IL-21 : Day 8 Post-Vaccination 11.149 (0.750 to 1.330)——
IL-21 : Day 29 Post-Vaccination 1—1.213 (1.150 to 1.440)0.916 (0.860 to 1.080)
IL-21 : Day 2 Post-Vaccination 2—1.099 (0.950 to 1.280)1.040 (0.850 to 1.060)
IL-21 : Day 4 Post-Vaccination 2—0.932 (0.770 to 1.030)0.924 (0.790 to 1.210)
IL-21 : Day 8 Post-Vaccination 2—0.861 (0.620 to 1.180)0.880 (0.720 to 1.180)
IL-23 : Day 2 Post-Vaccination 10.907 (0.820 to 1.060)0.998 (0.890 to 1.120)0.929 (0.830 to 1.300)
IL-23 : Day 4 Post-Vaccination 11.014 (0.780 to 1.470)1.006 (0.810 to 1.270)0.949 (0.820 to 1.230)
IL-23 : Day 8 Post-Vaccination 10.930 (0.690 to 1.060)——
IL-23 : Day 29 Post-Vaccination 1—1.041 (0.910 to 1.280)0.993 (0.720 to 1.180)
IL-23 : Day 2 Post-Vaccination 2—1.046 (0.890 to 1.240)0.956 (0.880 to 1.190)
IL-23 : Day 4 Post-Vaccination 2—1.032 (0.800 to 1.210)0.982 (0.700 to 1.280)
IL-23 : Day 8 Post-Vaccination 2—0.954 (0.770 to 1.460)0.979 (0.790 to 1.070)
IL-4 : Day 2 Post-Vaccination 10.992 (0.850 to 1.180)1.038 (0.930 to 1.130)1.034 (0.910 to 1.240)
IL-4 : Day 4 Post-Vaccination 11.013 (0.830 to 1.270)1.028 (0.840 to 1.170)0.921 (0.840 to 1.130)
IL-4 : Day 8 Post-Vaccination 10.969 (0.870 to 1.160)——
IL-4 : Day 29 Post-Vaccination 1—1.038 (0.910 to 1.190)1.014 (0.870 to 1.170)
IL-4 : Day 2 Post-Vaccination 2—1.014 (0.830 to 1.150)0.969 (0.860 to 1.060)
IL-4 : Day 4 Post-Vaccination 2—0.983 (0.830 to 1.130)0.935 (0.740 to 1.130)
IL-4 : Day 8 Post-Vaccination 2—1.083 (0.890 to 1.160)0.910 (0.730 to 1.080)
IL-5 : Day 2 Post-Vaccination 11.062 (0.850 to 1.220)1.029 (0.920 to 1.170)0.978 (0.840 to 1.100)
IL-5 : Day 4 Post-Vaccination 10.986 (0.830 to 1.240)1.074 (0.940 to 1.420)1.037 (0.770 to 1.270)
IL-5 : Day 8 Post-Vaccination 11.009 (0.800 to 1.110)——
IL-5 : Day 29 Post-Vaccination 1—1.010 (0.850 to 1.330)1.040 (0.900 to 1.150)
IL-5 : Day 2 Post-Vaccination 2—1.122 (0.980 to 1.380)0.980 (0.810 to 1.050)
IL-5 : Day 4 Post-Vaccination 2—1.022 (0.940 to 1.190)0.960 (0.870 to 1.190)
IL-5 : Day 8 Post-Vaccination 2—1.123 (0.750 to 1.350)0.965 (0.770 to 1.030)
IL-6 : Day 2 Post-Vaccination 11.123 (1.000 to 1.590)1.601 (1.250 to 2.140)0.952 (0.920 to 1.140)
IL-6 : Day 4 Post-Vaccination 11.075 (0.900 to 1.550)0.990 (0.700 to 1.150)0.969 (0.890 to 1.180)
IL-6 : Day 8 Post-Vaccination 10.970 (0.630 to 1.130)——
IL-6 : Day 29 Post-Vaccination 1—0.921 (0.700 to 1.500)0.996 (0.790 to 1.100)
IL-6 : Day 2 Post-Vaccination 2—1.827 (1.190 to 2.680)0.942 (0.870 to 1.110)
IL-6 : Day 4 Post-Vaccination 2—0.907 (0.800 to 1.150)1.054 (0.750 to 1.210)
IL-6 : Day 8 Post-Vaccination 2—0.921 (0.610 to 1.140)0.961 (0.790 to 1.110)
IL-7 : Day 2 Post-Vaccination 11.080 (0.840 to 1.220)1.010 (0.900 to 1.220)0.982 (0.840 to 1.250)
IL-7 : Day 4 Post-Vaccination 10.952 (0.680 to 1.310)1.009 (0.880 to 1.270)0.934 (0.800 to 1.350)
IL-7 : Day 8 Post-Vaccination 11.000 (0.790 to 1.170)——
IL-7 : Day 29 Post-Vaccination 1—0.969 (0.880 to 1.010)0.976 (0.760 to 1.150)
IL-7 : Day 2 Post-Vaccination 2—0.953 (0.840 to 1.280)0.979 (0.860 to 1.070)
IL-7 : Day 4 Post-Vaccination 2—0.816 (0.710 to 1.130)0.966 (0.880 to 1.250)
IL-7 : Day 8 Post-Vaccination 2—1.262 (1.020 to 1.460)1.022 (0.780 to 1.110)
IL-8 : Day 2 Post-Vaccination 11.111 (0.930 to 1.340)1.045 (0.860 to 1.110)0.960 (0.890 to 1.070)
IL-8 : Day 4 Post-Vaccination 11.073 (0.870 to 1.310)0.943 (0.880 to 1.060)0.944 (0.810 to 1.070)
IL-8 : Day 8 Post-Vaccination 11.039 (0.900 to 1.070)——
IL-8 : Day 29 Post-Vaccination 1—0.970 (0.790 to 1.310)0.914 (0.780 to 1.010)
IL-8 : Day 2 Post-Vaccination 2—1.134 (0.940 to 1.280)0.988 (0.940 to 1.070)
IL-8 : Day 4 Post-Vaccination 2—0.834 (0.730 to 1.040)1.065 (0.890 to 1.180)
IL-8 : Day 8 Post-Vaccination 2—1.299 (0.750 to 1.520)0.966 (0.900 to 1.040)
IL-12p70 : Day 2 Post-Vaccination 11.048 (0.930 to 1.200)1.029 (0.840 to 1.150)0.869 (0.730 to 1.100)
IL-12p70 : Day 4 Post-Vaccination 11.057 (0.920 to 1.140)1.029 (0.940 to 1.260)0.916 (0.810 to 1.030)
IL-12p70 : Day 8 Post-Vaccination 11.012 (0.780 to 1.100)——
IL-12p70 : Day 29 Post-Vaccination 1—1.052 (0.950 to 1.600)1.059 (0.650 to 1.140)
IL-12p70 : Day 2 Post-Vaccination 2—1.026 (0.860 to 1.240)1.002 (0.810 to 1.150)
IL-12p70 : Day 4 Post-Vaccination 2—0.933 (0.890 to 1.030)1.041 (0.800 to 1.400)
IL-12p70 : Day 8 Post-Vaccination 2—0.901 (0.820 to 1.220)0.936 (0.750 to 1.150)
IL-17A : Day 2 Post-Vaccination 11.011 (0.950 to 1.160)1.074 (0.920 to 1.120)0.932 (0.850 to 1.040)
IL-17A : Day 4 Post-Vaccination 11.053 (0.860 to 1.200)1.019 (0.920 to 1.180)0.911 (0.880 to 1.010)
IL-17A : Day 8 Post-Vaccination 10.965 (0.940 to 1.120)——
IL-17A : Day 29 Post-Vaccination 1—1.153 (1.010 to 1.320)0.908 (0.790 to 1.170)
IL-17A : Day 2 Post-Vaccination 2—0.970 (0.920 to 1.060)0.988 (0.910 to 1.020)
IL-17A : Day 4 Post-Vaccination 2—0.913 (0.820 to 0.980)0.999 (0.840 to 1.1170)
IL-17A : Day 8 Post-Vaccination 2—0.891 (0.610 to 1.170)0.956 (0.750 to 1.030)
MIP1a : Day 2 Post-Vaccination 11.024 (0.950 to 1.110)1.035 (0.990 to 1.040)0.963 (0.930 to 1.120)
MIP1a : Day 4 Post-Vaccination 11.089 (0.930 to 1.170)1.037 (0.940 to 1.110)0.997 (0.920 to 1.080)
MIP1a : Day 8 Post-Vaccination 10.966 (0.910 to 1.060)——
MIP1a : Day 29 Post-Vaccination 1—1.049 (0.870 to 1.170)1.018 (0.850 to 1.080)
MIP1a : Day 2 Post-Vaccination 2—1.018 (0.960 to 1.140)1.008 (0.910 to 1.050)
MIP1a : Day 4 Post-Vaccination 2—0.961 (0.850 to 1.060)0.978 (0.920 to 1.110)
MIP1a : Day 8 Post-Vaccination 2—1.097 (0.960 to 1.230)0.970 (0.890 to 1.040)
MIP1b : Day 2 Post-Vaccination 11.192 (0.880 to 1.270)1.187 (0.940 to 1.330)0.955 (0.910 to 1.090)
MIP1b : Day 4 Post-Vaccination 11.027 (0.810 to 1.180)1.030 (0.990 to 1.200)1.023 (0.860 to 1.210)
MIP1b : Day 8 Post-Vaccination 11.038 (1.010 to 1.070)——
MIP1b : Day 29 Post-Vaccination 1—0.958 (0.810 to 1.190)0.942 (0.840 to 1.050)
MIP1b : Day 2 Post-Vaccination 2—1.576 (1.240 to 2.210)0.950 (0.900 to 1.130)
MIP1b : Day 4 Post-Vaccination 2—0.985 (0.840 to 1.070)1.111 (0.850 to 1.220)
MIP1b : Day 8 Post-Vaccination 2—1.194 (0.860 to 1.320)0.960 (0.870 to 1.100)
MIP3a : Day 2 Post-Vaccination 11.085 (0.820 to 1.250)0.979 (0.820 to 1.010)0.968 (0.800 to 1.090)
MIP3a : Day 4 Post-Vaccination 11.056 (0.910 to 1.150)0.990 (0.820 to 1.130)0.976 (0.850 to 1.060)
MIP3a : Day 8 Post-Vaccination 10.976 (0.930 to 1.190)——
MIP3a : Day 29 Post-Vaccination 1—0.945 (0.900 to 1.080)0.891 (0.720 to 1.110)
MIP3a : Day 2 Post-Vaccination 2—1.033 (0.900 to 1.160)0.943 (0.850 to 1.230)
MIP3a : Day 4 Post-Vaccination 2—1.036 (0.910 to 1.200)1.021 (0.930 to 1.250)
MIP3a : Day 8 Post-Vaccination 2—1.055 (0.910 to 1.570)1.076 (0.900 to 1.670)
TNF-a : Day 2 Post-Vaccination 11.022 (1.000 to 1.360)1.132 (0.940 to 1.200)0.929 (0.850 to 1.080)
TNF-a : Day 4 Post-Vaccination 10.965 (0.920 to 1.330)1.148 (0.990 to 1.290)1.070 (0.860 to 1.180)
TNF-a : Day 8 Post-Vaccination 10.998 (0.880 to 1.070)——
TNF-a : Day 29 Post-Vaccination 1—0.977 (0.820 to 1.240)0.869 (0.790 to 1.060)
TNF-a : Day 2 Post-Vaccination 2—1.634 (1.380 to 1.950)1.009 (0.880 to 1.180)
TNF-a : Day 4 Post-Vaccination 2—1.112 (0.890 to 1.220)1.047 (0.840 to 1.320)
TNF-a : Day 8 Post-Vaccination 2—1.199 (0.770 to 1.460)0.984 (0.890 to 1.160)
SecondaryPercentage of Participants Achieving Seroconversion Based on Neut Titer (A/H7N9 Vaccine, With and Without Adjuvant)

Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

Time frame:
Day 29 Post-Vaccination 2 (Day 57)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H7N9 Vaccine, With and Without Adjuvant)
percentage of participantsA/H7N9 + AS03A/H7N9
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H7N9 Vaccine, With and Without Adjuvant)100 (69.2 to 100.0)0 (0.0 to 30.8)
SecondaryPercentage of Participants Achieving Seroconversion Based on Neut Titer (A/H3N2v Vaccine)

Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.

Time frame:
Day 29 Post-Vaccination 1 (Day 29)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H3N2v Vaccine)
percentage of participantsA/H3N2v
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H3N2v Vaccine)40 (12.2 to 73.8)
SecondaryGeometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)

Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

Time frame:
Day 1 Pre-Vaccination 1, Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)
Reported as:
Geometric mean · titer
Geometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
titerA/H7N9 + AS03A/H7N9
Day 1 (Pre-Vaccination 1)5.2 (4.8 to 5.6)5.0 (NA to NA)
Day 29 (Post-Vaccination 1)7.3 (4.2 to 12.9)5.2 (4.8 to 5.6)
Day 29 (Post-Vaccination 2)85.7 (26.7 to 275.6)5.0 (NA to NA)
SecondaryGeometric Mean Titers of Serum HAI Antibody (A/H3N2v Vaccine)

Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.

Time frame:
Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)
Reported as:
Geometric mean · titer
Geometric Mean Titers of Serum HAI Antibody (A/H3N2v Vaccine)
titerA/H3N2v
Day 1 Pre-Vaccination 137.3 (16.4 to 85.1)
Day 29 Post-Vaccination 1144.2 (44.8 to 464.2)
SecondaryGeometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)

Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.

Time frame:
Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)
Reported as:
Geometric mean · titer
Geometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
titerA/H7N9 + AS03A/H7N9
Day 1 (Pre-Vaccination 1)5.0 (NA to NA)5.0 (NA to NA)
Day 29 (Post-Vaccination 1)17.4 (11.6 to 26.2)5.4 (4.6 to 6.3)
Day 29 (Post-Vaccination 2)190.3 (112.5 to 321.9)5.9 (4.5 to 7.8)
SecondaryGeometric Mean Titers of Serum Neut Antibody (A/H3N2v Vaccine)

Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.

Time frame:
Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)
Reported as:
Geometric mean · titer
Geometric Mean Titers of Serum Neut Antibody (A/H3N2v Vaccine)
titerA/H3N2v
Day 1 Pre-Vaccination 1171.5 (86.1 to 341.7)
Day 29 Post-Vaccination 1485.0 (229.9 to 1023.2)

Adverse events

Collected over For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
A/H3N2v0/10 (0%)0/10 (0%)8/10 (80%)
A/H7N9 + AS030/10 (0%)0/10 (0%)10/10 (100%)
A/H7N9 + PBS0/10 (0%)1/10 (10%)7/10 (70%)
Most frequent serious events
Most frequent serious events
EventA/H3N2vA/H7N9 + AS03A/H7N9 + PBS
IntussusceptionGastrointestinal disorders0/100/101/10
Most frequent other events
Showing 10 of 23
Most frequent other events
EventA/H3N2vA/H7N9 + AS03A/H7N9 + PBS
Injection Site Pain (Tenderness)General disorders6/1010/102/10
Injection Site PainGeneral disorders0/108/100/10
FatigueGeneral disorders2/107/103/10
Injection Site ErythemaGeneral disorders2/107/101/10
MalaiseGeneral disorders1/106/103/10
Upper Respiratory Tract InfectionInfections and infestations1/101/105/10
Feeling HotGeneral disorders0/104/103/10
MyalgiaMusculoskeletal and connective tissue disorders1/104/101/10
HeadacheNervous system disorders4/104/103/10
Injection Site HaemorrhageGeneral disorders0/103/100/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)A/H3N2vA/H7N9 + AS03A/H7N9Total
<=18 years0000
Between 18 and 65 years10101030
>=65 years0000
Age, Continuous
Age, Continuous(years)A/H3N2vA/H7N9 + AS03A/H7N9Total
Mean31.0 ± 7.128.0 ± 6.233.7 ± 8.330.9 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)A/H3N2vA/H7N9 + AS03A/H7N9Total
Female77519
Male33511
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)A/H3N2vA/H7N9 + AS03A/H7N9Total
Hispanic or Latino0000
Not Hispanic or Latino10101030
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)A/H3N2vA/H7N9 + AS03A/H7N9Total
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White10101030
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)A/H3N2vA/H7N9 + AS03A/H7N9Total
United States10101030
BMI
BMI(kg/m^2)A/H3N2vA/H7N9 + AS03A/H7N9Total
Mean24.125 ± 5.60921.885 ± 2.52028.453 ± 10.76824.821 ± 7.443
08

Study locations

1 site
  • Vanderbilt University Medical Center - Vanderbilt Institute for Clinical and Translational Research - Clinical Research Center (VICTR-CRC)
    Nashville, Tennessee 37232-0011, United States
09

References and documents

Study documents

  • Study protocol · Jul 17, 2019
  • Statistical analysis plan · Nov 21, 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 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02921997
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Oct 3, 2016
Start date
Nov 7, 2016
Primary completion
Mar 28, 2017
Completion
Feb 14, 2018
Results posted
Jan 26, 2022
Last update
Oct 9, 2024

Oversight

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

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