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CompletedNCT03275389Updated May 7, 2021Results posted

A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

A Phase 1 interventional study of D-SUIV cH8/1N1+AS03 and D-SUIV cH5/1N1+AS03 in Influenza, Human, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-07.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

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Phase
Phase 1
Study type
Interventional
Enrollment
470
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 187 studies in Influenza, Human by GlaxoSmithKline — 3 open to participants now, 3 under way, 2 of them phase 3. Influenza, Human · GlaxoSmithKline.

Enrollment
65th of 165
470 · median 324
Started
2017
with 3 others
Phase 1
22 of 187
1 open now
Registered
171st of 187
by date

Among the 187 studies in Influenza, Human by GlaxoSmithKline, this one is the 65th largest by enrollment of the 165 interventional ones that give a count, is one of 4 that started in 2017, is one of 22 in phase 1, and was the 171st registered.

Influenza, Human

2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

Browse Influenza, Human studies →

Open to participants now

3 of the 187 studies in Influenza, Human by GlaxoSmithKline are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

United States3

All 3 open studies →

Who these studies take

Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.

This study: 18 Years to 39 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.

Read the detailed description

Current seasonal influenza vaccines show good efficacy when they are well-matched with the circulating virus strains.

However, influenza viruses constantly change their surface glycoproteins that are the targets of most immune responses, allowing them to escape pre-existing immunity, a process called antigenic drift. Therefore, seasonal influenza vaccines have to be reformulated and re-administered on an annual basis. In addition, novel viruses can appear at irregular intervals and cause influenza virus pandemics that can claim millions of lives.

GSK Biologicals is now developing a new influenza vaccine that contains modified inactivated influenza viruses. The purpose of this approach is to elicit an immune response that would protect against all current and future circulating influenza strains without having to administer the vaccine each year.

03

Conditions studied

  • Influenza, Human

Browse trials for

Keywords

  • Safety
  • Healthy adults
  • Immunogenicity
  • Supra-seasonal universal influenza vaccines - inactivated (SUIVs)
04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written obtained from the subject prior to performance of any study specific procedure.
  • A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
  • Healthy subjects without acute or chronic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
  • Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.

  • Female subjects of may be enrolled in the study, if the subject:

    • Has practiced adequate for 30 days prior to first vaccination, and
    • Has a negative pregnancy test on the day of vaccination, and
    • Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series (last vaccination at Month 14).

Exclusion criteria

Exclusion Criteria:

  • Use of any or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For , this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration any time during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
  • Previous vaccination against influenza within the 6 months preceding the first vaccination at Visit 1 or planned use of such vaccines during the study period.
  • History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09 vaccine or history of laboratory-confirmed influenza infection other than seasonal or H1N1pdm09 influenza.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current disease.
  • Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
  • History of Guillain-Barré syndrome.
  • History of any reaction or likely to be exacerbated by any component of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Hypersensitivity to latex.

  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    • For subjects with acute disease and/or fever at the time of enrolment, Visit 1 may be re-scheduled within the allowed time-window.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period.
  • Blood donation within 30 days before the first study blood sampling or planned blood donation within 30 days before and up to 30 days after any study blood sampling.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Female planning to become pregnant or planning to discontinue precautions.

Additional criterion applicable for Phase I subjects:

  • Hematological and/or biochemical parameters outside the laboratory normal ranges, unless the laboratory abnormalities are considered not by the investigator.
  • Liver enzymes ( [ALT] or aspartate aminotransferase [AST]) outside of the normal laboratory ranges.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
470 participants (actual)

Study arms

  • Experimental
    D-SUIV Adjuvanted Group 1

    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS03 · Biological: D-SUIV cH5/1N1+AS03 · Biological: Placebo

  • Experimental
    D-SUIV Adjuvanted Group 2

    Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS03 · Biological: D-SUIV cH5/1N1+AS03 · Biological: Placebo

  • Experimental
    D-SUIV Adjuvanted Group 3

    Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS03 · Biological: D-SUIV cH5/1N1+AS03 · Biological: D-SUIV cH11/1N1+AS03

  • Experimental
    D-SUIV Adjuvanted Group 4

    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS01 · Biological: D-SUIV cH5/1N1+AS01 · Biological: Placebo

  • Experimental
    D-SUIV Adjuvanted Group 5

    Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS01 · Biological: D-SUIV cH5/1N1+AS01 · Biological: Placebo

  • Experimental
    D-SUIV Adjuvanted Group 6

    Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1+AS01 · Biological: D-SUIV cH5/1N1+AS01 · Biological: D-SUIV cH11/1N1+AS01

  • Experimental
    D-SUIV Unadjuvanted Group 1

    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1 · Biological: D-SUIV cH5/1N1 · Biological: Placebo

  • Experimental
    D-SUIV Unadjuvanted Group 2

    Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1 · Biological: D-SUIV cH5/1N1 · Biological: Placebo

  • Experimental
    D-SUIV Unadjuvanted Group 3

    Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: D-SUIV cH8/1N1 · Biological: D-SUIV cH5/1N1 · Biological: D-SUIV cH11/1N1

  • Active comparator
    IIV4 Group

    Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

    Biological: Placebo · Biological: Fluarix Quadrivalent

Interventions

  • BiologicalD-SUIV cH8/1N1+AS03

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH5/1N1+AS03

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH11/1N1+AS03

    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH8/1N1+AS01

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH5/1N1+AS01

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH11/1N1+AS01

    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH8/1N1

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH5/1N1

    1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

  • BiologicalD-SUIV cH11/1N1

    1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.

  • BiologicalPlacebo

    1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.

  • BiologicalFluarix Quadrivalent

    1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.

06

What researchers measure

Primary outcomes

  1. Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration

    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.

    Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose

  2. Number of Subjects With Solicited Local AEs After Second Dose Administration

    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.

    Time frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose

  3. Number of Subjects With Solicited Local AEs After Booster Dose Administration

    Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.

    Time frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose

  4. Number of Subjects With Solicited General AEs After First Dose Administration

    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade

    Time frame: During the 7-day (Days 1-7) follow-up period after first vaccine dose

  5. Number of Subjects With Solicited General AEs After Second Dose Administration

    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade

    Time frame: During the 7-day (Days 1-7) follow-up period after second vaccine dose

  6. Number of Subjects With Solicited General AEs After Booster Dose Administration

    Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

    Time frame: During the 7-day (Days 1-7) follow-up period after booster vaccine dose

  7. Number of Subjects With Any Unsolicited AEs Post-vaccination Period

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination

    Time frame: During the 28-day (Days 1-28) follow-up period accross doses

  8. Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading

    Hematological parameters assessed are: Eosinophils increase \[EOSi\], hemoglobin decrease \[HEMd\] , lymphocytes decrease \[LYMd\], Neutrophils decrease \[NEUd\], platelets decrease \[PLTCd\], white blood cells decrease \[WBCd\], WBC increase \[WBCi\]. Biochemical parameters assessed are: alanine aminotransferase increase \[ALTi\], aspartate aminotransferase increase \[ASTi\], blood urea nitrogen \[BUN\], creatinine \[CRE\].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".

    Time frame: At Day 8

  9. Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading

    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

    Time frame: From Day 8 to Day 29

  10. Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading

    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

    Time frame: From Day 8 to Day 85

  11. Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading

    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

    Time frame: From Day 8 to Month 14 + 28 days

  12. Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading

    Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

    Time frame: From Day 8 to Month 26

  13. Number of Subjects With Any Medically-attended Adverse Events (MAEs)

    MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

    Time frame: During the entire study period (from Day 1 up to Month 26)

  14. Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)

    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

    Time frame: During the entire study period (from Day 1 up to Month 26)

  15. Number of Subjects With Serious Adverse Events (SAEs).

    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Time frame: During the entire study period (from Day 1 up to Month 26)

  16. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1

    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).

    Time frame: At Day 1

  17. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29

    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

    Time frame: At Day 29

  18. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85

    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

    Time frame: At Day 85

  19. Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1

    Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

    Time frame: At Day 1

  20. Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29

    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

    Time frame: At Day 29

  21. Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85

    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

    Time frame: At Day 85

  22. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1

    Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

    Time frame: At Day 1

  23. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29

    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

    Time frame: At Day 29

  24. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85

    Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

    Time frame: At Day 85

  25. Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1

    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

    Time frame: At Day 1

  26. Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29

    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

    Time frame: At Day 29

  27. Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85

    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

    Time frame: At Day 85

  28. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

    Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  29. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Day 85, compared to pre-vaccination at Day 1

  30. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  31. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 85, compared to pre-vaccination at Day 1

  32. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  33. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Day 85, compared to pre-vaccination at Day 1

  34. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  35. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 85, compared to pre-vaccination at Day 1

  36. Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  37. MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

    Time frame: At Day 85, compared to pre-vaccination at Day 1

  38. MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29

    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

    Time frame: At Day 29, compared to pre-vaccination at Day 1

  39. MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85

    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

    Time frame: At Day 85, compared to pre-vaccination at Day 1

Secondary outcomes

  1. Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA

    The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.

    Time frame: 28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groups

  2. Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

    Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.

  3. Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

    Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

    Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.

  4. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.

    Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  5. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.

    Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

    Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  6. MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26

    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

    Time frame: At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  7. Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA

    Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).

    Time frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26

  8. Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA

    Anti-H2 and anti-H18 immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).

    Time frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26

  9. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA

    Percentage of subjects with a ≥ 4-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .

    Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  10. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA

    Percentage of subjects with a ≥ 10-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .

    Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  11. MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA

    MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1.

    Time frame: At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1

  12. Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay

    Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL

    Time frame: At Days 1, 29 and 85

  13. Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay

    Anti-H1N1 swine influenza and anti-IIV4-H1N1 immune response measured by MN assay. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: cut-off = 20 1/DIL.

    Time frame: At Days 1, 29 and 85

  14. Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay

    Percentage of subjects with a ≥ 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 29 and Day 85, compared to Day 1

  15. Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay

    Percentage of subjects with a ≥ 10-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.

    Time frame: At Day 29 and Day 85, compared to Day 1

  16. MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay

    MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1.

    Time frame: At Day 29 and at Day 85, compared to Day 1

07

Results

Posted May 7, 2021

Participant flow

Participant flow — Overall Study
MilestoneD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Started45464747484747484647
Completed34302425322922303129
Not completed11162322161825181518
Withdrew: Lost to follow-up10101912111221151214
Withdrew: Serious adverse event and/or pimd0000010001
Withdrew: Consent withdrawal not due to adv. event1005333322
Withdrew: Migrated / moved from the study area0203001000
Withdrew: Not willing to participate this visit0010000001
Withdrew: Other0432220010

Outcome measures

PrimaryNumber of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration

Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.

Time frame:
During the 7-day (Days 1-7) follow-up period after first vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Erythema1322131010
Pain34423739404216131535
Swelling4224320010
PrimaryNumber of Subjects With Solicited Local AEs After Second Dose Administration

Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.

Time frame:
During the 7-day (Days 1-7) follow-up period after second vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited Local AEs After Second Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Erythema0010000000
Pain52292832451210
Swelling0040020000
PrimaryNumber of Subjects With Solicited Local AEs After Booster Dose Administration

Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.

Time frame:
During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited Local AEs After Booster Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Erythema1100110000
Pain2731262928254101321
Swelling2201110000
PrimaryNumber of Subjects With Solicited General AEs After First Dose Administration

Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade

Time frame:
During the 7-day (Days 1-7) follow-up period after first vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited General AEs After First Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Arthralgia4692386525
Fatigue17182218211817191212
Gastrointestinal symptoms671068868108
Headache18181923162616191514
Myalgia16131917192099611
Shivering631010892223
Temperature1102211100
PrimaryNumber of Subjects With Solicited General AEs After Second Dose Administration

Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade

Time frame:
During the 7-day (Days 1-7) follow-up period after second vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited General AEs After Second Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Arthralgia3440440022
Fatigue771067855105
Gastrointestinal symptoms3443361422
Headache81213791251287
Myalgia561214163263
Shivering2440351021
Temperature1200120000
PrimaryNumber of Subjects With Solicited General AEs After Booster Dose Administration

Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as oral temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Time frame:
During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Reported as:
Count of participants · Participants
Number of Subjects With Solicited General AEs After Booster Dose Administration
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Arthralgia6844941121
Fatigue151917162092663
Gastrointestinal symptoms3885651240
Headache913141516153764
Myalgia1517151513100453
Shivering513661490121
Temperature2314210000
PrimaryNumber of Subjects With Any Unsolicited AEs Post-vaccination Period

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination

Time frame:
During the 28-day (Days 1-28) follow-up period accross doses
Reported as:
Count of participants · Participants
Number of Subjects With Any Unsolicited AEs Post-vaccination Period
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Subjects With Any Unsolicited AEs Post-vaccination Period27232324241722232221
PrimaryNumber of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading

Hematological parameters assessed are: Eosinophils increase \[EOSi\], hemoglobin decrease \[HEMd\] , lymphocytes decrease \[LYMd\], Neutrophils decrease \[NEUd\], platelets decrease \[PLTCd\], white blood cells decrease \[WBCd\], WBC increase \[WBCi\]. Biochemical parameters assessed are: alanine aminotransferase increase \[ALTi\], aspartate aminotransferase increase \[ASTi\], blood urea nitrogen \[BUN\], creatinine \[CRE\].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".

Time frame:
At Day 8
Reported as:
Count of participants · Participants
Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
ALTi, UNKNOWN, GRADE 00000000010
ALTi, UNKNOWN, GRADE 10000001000
ALTi, GRADE 0, UNKNOWN0003001001
ALTi, GRADE 0, GRADE 040454241454543444144
ALTi, GRADE 0, GRADE 10110000021
ALTi, GRADE 0, GRADE 30001000000
ALTi, GRADE 1, GRADE 03011100220
ALTi, GRADE 1, GRADE 11010010100
ASTi, UNKNOWN, GRADE 00000001010
ASTi, GRADE 0, UNKNOWN0003001001
ASTi, GRADE 0, GRADE 044464442464542444444
ASTi, GRADE 0, GRADE 10010000200
ASTi, GRADE 0, GRADE 20000000011
ASTi, GRADE 0, GRADE 40001000000
ASTi, GRADE 1, GRADE 00000011000
ASTi, GRADE 2, GRADE 00000000100
BUN, UNKNOWN, GRADE 00000001010
BUN, GRADE 0, UNKNOWN0003001001
BUN, GRADE 0, GRADE 043464543464643474345
BUN, GRADE 1, GRADE 01000000010
BUN, GRADE 2, GRADE 00000000010
CRE, UNKNOWN, GRADE 00000001010
CRE, GRADE 0, UNKNOWN0003001001
CRE, GRADE 0, GRADE 044464543464643474545
EOSi, UNKNOWN, GRADE 01131111252
EOSi, GRADE 0, UNKNOWN2021002212
EOSi, GRADE 0, GRADE 041433843454440433841
EOSi, GRADE 0, GRADE 10110012010
EOSi, GRADE 1, GRADE 00111000000
EOSi, GRADE 1, GRADE 10000000011
HEMd, UNKNOWN, GRADE 00100001001
HEMd, GRADE 0, UNKNOWN1011001112
HEMd, GRADE 0, GRADE 037374039434037404040
HEMd, GRADE 0, GRADE 11411131121
HEMd, GRADE 0, GRADE 20001000000
HEMd, GRADE 1, UNKNOWN0000001000
HEMd, GRADE 1, GRADE 00000001201
HEMd, GRADE 1, GRADE 13124012000
HEMd, GRADE 1, GRADE 20200010011
HEMd, GRADE 2, GRADE 10000001000
HEMd, GRADE 2, GRADE 22010210020
HEMd, GRADE 2, GRADE 30000000200
HEMd, GRADE 3, UNKNOWN0000000100
HEMd, GRADE 3, GRADE 30100000000
LYMd, UNKNOWN, GRADE 01131111252
LYMd, GRADE 0, UNKNOWN2021002212
LYMd, GRADE 0, GRADE 039453744434542423841
LYMd, GRADE 0, GRADE 12000100101
LYMd, GRADE 1, GRADE 00020000020
LYMd, GRADE 1, GRADE 20010000000
LYMd, GRADE 2, GRADE 00000100000
NEUd, UNKNOWN, GRADE 01131111221
NEUd, UNKNOWN, GRADE 10000000021
NEUd, UNKNOWN, GRADE 20000000010
NEUd, GRADE 0, UNKNOWN2021002212
NEUd, GRADE 0, GRADE 037403941414339383737
NEUd, GRADE 0, GRADE 12101001102
NEUd, GRADE 0, GRADE 20001011010
NEUd, GRADE 1, GRADE 01400010011
NEUd, GRADE 1, GRADE 11000201200
NEUd, GRADE 1, GRADE 20001000000
NEUd, GRADE 2, GRADE 00010100212
NEUd, GRADE 3, GRADE 00000100000
PLTCd, UNKNOWN, GRADE 00100001011
PLTCd, GRADE 0, UNKNOWN1021002212
PLTCd, GRADE 0, GRADE 043454243464542444343
PLTCd, GRADE 0, GRADE 10000010000
PLTCd, GRADE 0, GRADE 20010000000
PLTCd, GRADE 1, GRADE 00001000100
PLTCd, GRADE 1, GRADE 10001000000
PLTCd, GRADE 2, GRADE 10000000010
WBCd, UNKNOWN, GRADE 00100001021
WBCd, GRADE 0, UNKNOWN1021002212
WBCd, GRADE 0, GRADE 041454244444641424143
WBCd, GRADE 0, GRADE 11001001000
WBCd, GRADE 1, GRADE 01010100320
WBCd, GRADE 2, GRADE 00000100000
WBCi, UNKNOWN, GRADE 00100001021
WBCi, GRADE 0, UNKNOWN1021002212
WBCi, GRADE 0, GRADE 041434242454539393839
WBCi, GRADE 0, GRADE 10001011313
WBCi, GRADE 1, GRADE 01201101120
WBCi, GRADE 1, GRADE 11011001211
WBCi, GRADE 2, GRADE 10000000010
PrimaryNumber of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

Time frame:
From Day 8 to Day 29
Reported as:
Count of participants · Participants
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
ALTi, UNKNOWN, GRADE 00000000010
ALTi, UNKNOWN, GRADE 10000001000
ALTi, GRADE 0, UNKNOWN0000001000
ALTi, GRADE 0, GRADE 040454144454441434044
ALTi, GRADE 0, GRADE 10120012032
ALTi, GRADE 0, GRADE 20000000100
ALTi, GRADE 0, GRADE 30001000000
ALTi, GRADE 1, GRADE 03011100220
ALTi, GRADE 1, GRADE 11010010100
ASTi, UNKNOWN, GRADE 00000001010
ASTi, GRADE 0, UNKNOWN0000001000
ASTi, GRADE 0, GRADE 044464445464442434245
ASTi, GRADE 0, GRADE 10010010320
ASTi, GRADE 0, GRADE 20000000011
ASTi, GRADE 0, GRADE 40001000000
ASTi, GRADE 1, GRADE 00000001000
ASTi, GRADE 1, GRADE 10000010000
ASTi, GRADE 2, GRADE 00000000100
BUN, UNKNOWN, GRADE 00000001010
BUN, GRADE 0, UNKNOWN0000001000
BUN, GRADE 0, GRADE 043454546464643474346
BUN, GRADE 0, GRADE 10100000000
BUN, GRADE 1, GRADE 01000000010
BUN, GRADE 2, GRADE 00000000010
CRE, UNKNOWN, GRADE 00000001010
CRE, GRADE 0, UNKNOWN0000001000
CRE, GRADE 0, GRADE 044464546464643474546
EOSi, UNKNOWN, GRADE 01131110252
EOSi, UNKNOWN, GRADE 10000001000
EOSi, GRADE 0, UNKNOWN0000001000
EOSi, GRADE 0, GRADE 043434044454440453943
EOSi, GRADE 0, GRADE 10110013010
EOSi, GRADE 1, GRADE 00011000000
EOSi, GRADE 1, GRADE 10100000011
HEMd, UNKNOWN, GRADE 00100001001
HEMd, GRADE 0, GRADE 037374138434037393942
HEMd, GRADE 0, GRADE 12413132341
HEMd, GRADE 0, GRADE 20001000000
HEMd, GRADE 1, UNKNOWN0000001000
HEMd, GRADE 1, GRADE 00000001201
HEMd, GRADE 1, GRADE 13124012000
HEMd, GRADE 1, GRADE 20200010011
HEMd, GRADE 2, GRADE 22010211020
HEMd, GRADE 2, GRADE 30000000200
HEMd, GRADE 3, GRADE 30100000100
LYMd, UNKNOWN, GRADE 00131111252
LYMd, UNKNOWN, GRADE 11000000000
LYMd, GRADE 0, UNKNOWN0000001000
LYMd, GRADE 0, GRADE 041453945424543433941
LYMd, GRADE 0, GRADE 12000100203
LYMd, GRADE 0, GRADE 20000100000
LYMd, GRADE 1, GRADE 00010000000
LYMd, GRADE 1, GRADE 10010000020
LYMd, GRADE 1, GRADE 20010000000
LYMd, GRADE 2, GRADE 00000100000
NEUd, UNKNOWN, GRADE 00131111221
NEUd, UNKNOWN, GRADE 11000000020
NEUd, UNKNOWN, GRADE 20000000011
NEUd, GRADE 0, UNKNOWN0000001000
NEUd, GRADE 0, GRADE 038394040404237383838
NEUd, GRADE 0, GRADE 13212112302
NEUd, GRADE 0, GRADE 20001013011
NEUd, GRADE 0, GRADE 30001000000
NEUd, GRADE 1, GRADE 01300010000
NEUd, GRADE 1, GRADE 11100101111
NEUd, GRADE 1, GRADE 20001100100
NEUd, GRADE 2, GRADE 00010000111
NEUd, GRADE 2, GRADE 10000100100
NEUd, GRADE 2, GRADE 20000000001
NEUd, GRADE 3, GRADE 00000100000
PLTCd, UNKNOWN, GRADE 00100001011
PLTCd, GRADE 0, UNKNOWN0000001000
PLTCd, GRADE 0, GRADE 043454444464543464445
PLTCd, GRADE 0, GRADE 11000010000
PLTCd, GRADE 0, GRADE 20010000000
PLTCd, GRADE 1, GRADE 00001000100
PLTCd, GRADE 1, GRADE 20001000000
PLTCd, GRADE 2, GRADE 10000000010
WBCd, UNKNOWN, GRADE 00100001010
WBCd, UNKNOWN, GRADE 10000000011
WBCd, GRADE 0, UNKNOWN0000001000
WBCd, GRADE 0, GRADE 041444443434642444142
WBCd, GRADE 0, GRADE 12103101013
WBCd, GRADE 1, GRADE 01010100320
WBCd, GRADE 2, GRADE 00000100000
WBCi, UNKNOWN, GRADE 00100001021
WBCi, GRADE 0, UNKNOWN0000001000
WBCi, GRADE 0, GRADE 042404342454538393941
WBCi, GRADE 0, GRADE 10312013513
WBCi, GRADE 1, GRADE 00001101120
WBCi, GRADE 1, GRADE 11211001211
WBCi, GRADE 1, GRADE 21000000000
WBCi, GRADE 2, GRADE 10000000010
PrimaryNumber of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

Time frame:
From Day 8 to Day 85
Reported as:
Count of participants · Participants
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 85 Versus Baseline by Toxicity Grading
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
ALTi, UNKNOWN, GRADE 00000000010
ALTi, UNKNOWN, GRADE 10000001000
ALTi, GRADE 0, UNKNOWN0000001000
ALTi, GRADE 0, GRADE 039423942444239393543
ALTi, GRADE 0, GRADE 10442034483
ALTi, GRADE 0, GRADE 20000100100
ALTi, GRADE 0, GRADE 31001000000
ALTi, GRADE 1, GRADE 03011100220
ALTi, GRADE 1, GRADE 11010010100
ASTi, UNKNOWN, GRADE 00000001010
ASTi, GRADE 0, UNKNOWN0000001000
ASTi, GRADE 0, GRADE 043444345434339434045
ASTi, GRADE 0, GRADE 10220223340
ASTi, GRADE 0, GRADE 20000100011
ASTi, GRADE 0, GRADE 41001000000
ASTi, GRADE 1, GRADE 10000011000
ASTi, GRADE 2, GRADE 00000000100
BUN, UNKNOWN, GRADE 00000001010
BUN, GRADE 0, UNKNOWN0000001000
BUN, GRADE 0, GRADE 042454544454543464245
BUN, GRADE 0, GRADE 11101110111
BUN, GRADE 0, GRADE 20001000000
BUN, GRADE 1, GRADE 01000000010
BUN, GRADE 2, GRADE 00000000010
CRE, UNKNOWN, GRADE 00000001010
CRE, GRADE 0, UNKNOWN0000001000
CRE, GRADE 0, GRADE 044464546464643474546
EOSi, UNKNOWN, GRADE 01131110252
EOSi, UNKNOWN, GRADE 10000001000
EOSi, GRADE 0, UNKNOWN0000001000
EOSi, GRADE 0, GRADE 043403944454440433643
EOSi, GRADE 0, GRADE 10420013240
EOSi, GRADE 1, GRADE 00011000000
EOSi, GRADE 1, GRADE 10100000011
HEMd, UNKNOWN, GRADE 00100001001
HEMd, GRADE 0, GRADE 037344135423737393940
HEMd, GRADE 0, GRADE 12716262343
HEMd, GRADE 0, GRADE 20001000000
HEMd, GRADE 1, UNKNOWN0000001000
HEMd, GRADE 1, GRADE 00000000201
HEMd, GRADE 1, GRADE 12113012000
HEMd, GRADE 1, GRADE 21211011011
HEMd, GRADE 2, GRADE 21010211010
HEMd, GRADE 2, GRADE 31000000210
HEMd, GRADE 3, GRADE 30100000100
LYMd, UNKNOWN, GRADE 00131111252
LYMd, UNKNOWN, GRADE 11000000000
LYMd, GRADE 0, UNKNOWN0000001000
LYMd, GRADE 0, GRADE 041413944404443413840
LYMd, GRADE 0, GRADE 12101310414
LYMd, GRADE 0, GRADE 20200100000
LYMd, GRADE 0, GRADE 30100000000
LYMd, GRADE 1, GRADE 00010000000
LYMd, GRADE 1, GRADE 10010000020
LYMd, GRADE 1, GRADE 20010000000
LYMd, GRADE 2, GRADE 00000100000
NEUd, UNKNOWN, GRADE 00120101121
NEUd, UNKNOWN, GRADE 11011010010
NEUd, UNKNOWN, GRADE 20000000111
NEUd, UNKNOWN, GRADE 30000000010
NEUd, GRADE 0, UNKNOWN0000001000
NEUd, GRADE 0, GRADE 037354036373937353637
NEUd, GRADE 0, GRADE 14414242423
NEUd, GRADE 0, GRADE 20102113111
NEUd, GRADE 0, GRADE 30102100100
NEUd, GRADE 1, GRADE 01200010000
NEUd, GRADE 1, GRADE 11200100111
NEUd, GRADE 1, GRADE 20001101100
NEUd, GRADE 2, GRADE 00010000001
NEUd, GRADE 2, GRADE 10000000200
NEUd, GRADE 2, GRADE 20000100011
NEUd, GRADE 3, GRADE 10000100000
PLTCd, UNKNOWN, GRADE 00100001011
PLTCd, GRADE 0, UNKNOWN0000001000
PLTCd, GRADE 0, GRADE 042454443464543454445
PLTCd, GRADE 0, GRADE 12000010100
PLTCd, GRADE 0, GRADE 20011000000
PLTCd, GRADE 1, GRADE 00001000100
PLTCd, GRADE 1, GRADE 30001000000
PLTCd, GRADE 2, GRADE 10000000010
WBCd, UNKNOWN, GRADE 00100001010
WBCd, UNKNOWN, GRADE 10000000011
WBCd, GRADE 0, UNKNOWN0000001000
WBCd, GRADE 0, GRADE 041434441414642424041
WBCd, GRADE 0, GRADE 12205201224
WBCd, GRADE 0, GRADE 20000100000
WBCd, GRADE 1, GRADE 01010100220
WBCd, GRADE 1, GRADE 10000000100
WBCd, GRADE 2, GRADE 10000100000
WBCi, UNKNOWN, GRADE 00100001021
WBCi, GRADE 0, UNKNOWN0000001000
WBCi, GRADE 0, GRADE 041394239454436393839
WBCi, GRADE 0, GRADE 11425025515
WBCi, GRADE 0, GRADE 30000000010
WBCi, GRADE 1, GRADE 00001100110
WBCi, GRADE 1, GRADE 11211002221
WBCi, GRADE 1, GRADE 21000000000
WBCi, GRADE 2, GRADE 10000000010
PrimaryNumber of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

Time frame:
From Day 8 to Month 14 + 28 days
Reported as:
Count of participants · Participants
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 14+28 Days Versus Baseline by Toxicity Grading
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
ALTi, UNKNOWN, GRADE 00000000010
ALTi, UNKNOWN, GRADE 10000001000
ALTi, GRADE 0, UNKNOWN0000001000
ALTi, GRADE 0, GRADE 038383942404138393040
ALTi, GRADE 0, GRADE 118324354136
ALTi, GRADE 0, GRADE 20010110100
ALTi, GRADE 0, GRADE 31001000000
ALTi, GRADE 1, GRADE 03011100220
ALTi, GRADE 1, GRADE 11010010100
ASTi, UNKNOWN, GRADE 00000000010
ASTi, UNKNOWN, GRADE 10000001000
ASTi, GRADE 0, UNKNOWN0000001000
ASTi, GRADE 0, GRADE 042434144424337423743
ASTi, GRADE 0, GRADE 11331325472
ASTi, GRADE 0, GRADE 20010100011
ASTi, GRADE 0, GRADE 41001000000
ASTi, GRADE 1, GRADE 10000011000
ASTi, GRADE 2, GRADE 00000000100
BUN, UNKNOWN, GRADE 00000001010
BUN, GRADE 0, UNKNOWN0000001000
BUN, GRADE 0, GRADE 041454544454542464145
BUN, GRADE 0, GRADE 11100111121
BUN, GRADE 0, GRADE 21001000000
BUN, GRADE 0, GRADE 30001000000
BUN, GRADE 1, GRADE 01000000010
BUN, GRADE 2, GRADE 00000000010
CRE, UNKNOWN, GRADE 00000001010
CRE, GRADE 0, UNKNOWN0000001000
CRE, GRADE 0, GRADE 044464546464643474546
EOSi, UNKNOWN, GRADE 01131110252
EOSi, UNKNOWN, GRADE 10000001000
EOSi, GRADE 0, UNKNOWN0000001000
EOSi, GRADE 0, GRADE 042403943454439423443
EOSi, GRADE 0, GRADE 11421014360
EOSi, GRADE 1, GRADE 00011000000
EOSi, GRADE 1, GRADE 10100000011
HEMd, UNKNOWN, GRADE 00100001001
HEMd, GRADE 0, GRADE 035333933393735363939
HEMd, GRADE 0, GRADE 14838553644
HEMd, GRADE 0, GRADE 20001011000
HEMd, GRADE 1, UNKNOWN0000001000
HEMd, GRADE 1, GRADE 00000000201
HEMd, GRADE 1, GRADE 12113012000
HEMd, GRADE 1, GRADE 20211011011
HEMd, GRADE 1, GRADE 31000000000
HEMd, GRADE 2, GRADE 21010111010
HEMd, GRADE 2, GRADE 30000100210
HEMd, GRADE 2, GRADE 41000000000
HEMd, GRADE 3, GRADE 30100000100
LYMd, UNKNOWN, GRADE 00031111242
LYMd, UNKNOWN, GRADE 11100000010
LYMd, GRADE 0, UNKNOWN0000001000
LYMd, GRADE 0, GRADE 040413944404443383840
LYMd, GRADE 0, GRADE 13101310714
LYMd, GRADE 0, GRADE 20200100000
LYMd, GRADE 0, GRADE 30100000000
LYMd, GRADE 1, GRADE 00010000000
LYMd, GRADE 1, GRADE 10010000020
LYMd, GRADE 1, GRADE 20010000000
LYMd, GRADE 2, GRADE 10000100000
NEUd, UNKNOWN, GRADE 00120101121
NEUd, UNKNOWN, GRADE 11011010010
NEUd, UNKNOWN, GRADE 20000000111
NEUd, UNKNOWN, GRADE 30000000010
NEUd, GRADE 0, UNKNOWN0000001000
NEUd, GRADE 0, GRADE 036343735363834353434
NEUd, GRADE 0, GRADE 15425355446
NEUd, GRADE 0, GRADE 20222113111
NEUd, GRADE 0, GRADE 30102100100
NEUd, GRADE 1, GRADE 01200010000
NEUd, GRADE 1, GRADE 10200100101
NEUd, GRADE 1, GRADE 21001101110
NEUd, GRADE 2, GRADE 00010000001
NEUd, GRADE 2, GRADE 10000000200
NEUd, GRADE 2, GRADE 20000100011
NEUd, GRADE 3, GRADE 10000100000
PLTCd, UNKNOWN, GRADE 00100001011
PLTCd, GRADE 0, UNKNOWN0000001000
PLTCd, GRADE 0, GRADE 042454443464543454445
PLTCd, GRADE 0, GRADE 12000010100
PLTCd, GRADE 0, GRADE 20011000000
PLTCd, GRADE 1, GRADE 00001000100
PLTCd, GRADE 1, GRADE 30001000000
PLTCd, GRADE 2, GRADE 20000000010
WBCd, UNKNOWN, GRADE 00100001010
WBCd, UNKNOWN, GRADE 10000000011
WBCd, GRADE 0, UNKNOWN0000001000
WBCd, GRADE 0, GRADE 041424140414642413841
WBCd, GRADE 0, GRADE 12336201344
WBCd, GRADE 0, GRADE 20000100000
WBCd, GRADE 1, GRADE 00010100220
WBCd, GRADE 1, GRADE 11000000100
WBCd, GRADE 2, GRADE 10000100000
WBCi, UNKNOWN, GRADE 00100001021
WBCi, GRADE 0, UNKNOWN0000001000
WBCi, GRADE 0, GRADE 039394037434335373636
WBCi, GRADE 0, GRADE 13446235637
WBCi, GRADE 0, GRADE 20001001101
WBCi, GRADE 0, GRADE 30000000010
WBCi, GRADE 1, GRADE 00001100110
WBCi, GRADE 1, GRADE 11211002211
WBCi, GRADE 1, GRADE 21000000010
WBCi, GRADE 2, GRADE 10000000010
PrimaryNumber of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

Time frame:
From Day 8 to Month 26
Reported as:
Count of participants · Participants
Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Month 26 Versus Baseline by Toxicity Grading
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
ALTi, UNKNOWN, GRADE 00000000010
ALTi, UNKNOWN, GRADE 10000001000
ALTi, GRADE 0, UNKNOWN0000001000
ALTi, GRADE 0, GRADE 038383942403937382940
ALTi, GRADE 0, GRADE 118324565146
ALTi, GRADE 0, GRADE 20010110100
ALTi, GRADE 0, GRADE 31001000000
ALTi, GRADE 1, GRADE 02011100210
ALTi, GRADE 1, GRADE 12010010110
ASTi, UNKNOWN, GRADE 00000000010
ASTi, UNKNOWN, GRADE 10000001000
ASTi, GRADE 0, UNKNOWN0000001000
ASTi, GRADE 0, GRADE 042424144424236423743
ASTi, GRADE 0, GRADE 11431316472
ASTi, GRADE 0, GRADE 20010120011
ASTi, GRADE 0, GRADE 41001000000
ASTi, GRADE 1, GRADE 10000011000
ASTi, GRADE 2, GRADE 00000000100
BUN, UNKNOWN, GRADE 00000001010
BUN, GRADE 0, UNKNOWN0000001000
BUN, GRADE 0, GRADE 040454544454542464145
BUN, GRADE 0, GRADE 12100111121
BUN, GRADE 0, GRADE 21001000000
BUN, GRADE 0, GRADE 30001000000
BUN, GRADE 1, GRADE 01000000000
BUN, GRADE 1, GRADE 10000000010
BUN, GRADE 2, GRADE 00000000010
CRE, UNKNOWN, GRADE 00000001010
CRE, GRADE 0, UNKNOWN0000001000
CRE, GRADE 0, GRADE 044464546464643474546
EOSi, UNKNOWN, GRADE 01131110252
EOSi, UNKNOWN, GRADE 10000001000
EOSi, GRADE 0, UNKNOWN0000001000
EOSi, GRADE 0, GRADE 042403943454438413442
EOSi, GRADE 0, GRADE 11421015461
EOSi, GRADE 1, GRADE 00011000000
EOSi, GRADE 1, GRADE 10100000011
HEMd, UNKNOWN, GRADE 00100001001
HEMd, GRADE 0, GRADE 033323731383635353739
HEMd, GRADE 0, GRADE 15957663654
HEMd, GRADE 0, GRADE 21004011100
HEMd, GRADE 0, GRADE 30000000010
HEMd, GRADE 1, UNKNOWN0000001000
HEMd, GRADE 1, GRADE 00000000201
HEMd, GRADE 1, GRADE 12113012000
HEMd, GRADE 1, GRADE 20211011011
HEMd, GRADE 1, GRADE 31000000000
HEMd, GRADE 2, GRADE 21010111010
HEMd, GRADE 2, GRADE 30000100210
HEMd, GRADE 2, GRADE 41000000000
HEMd, GRADE 3, GRADE 30100000100
LYMd, UNKNOWN, GRADE 00031111242
LYMd, UNKNOWN, GRADE 11100000010
LYMd, GRADE 0, UNKNOWN0000001000
LYMd, GRADE 0, GRADE 039403944404443373840
LYMd, GRADE 0, GRADE 14101310814
LYMd, GRADE 0, GRADE 20300100000
LYMd, GRADE 0, GRADE 30100000000
LYMd, GRADE 1, GRADE 00010000000
LYMd, GRADE 1, GRADE 10010000020
LYMd, GRADE 1, GRADE 20010000000
LYMd, GRADE 2, GRADE 10000100000
NEUd, UNKNOWN, GRADE 00120101121
NEUd, UNKNOWN, GRADE 11011010010
NEUd, UNKNOWN, GRADE 20000000111
NEUd, UNKNOWN, GRADE 30000000010
NEUd, GRADE 0, UNKNOWN0000001000
NEUd, GRADE 0, GRADE 035343735363634353434
NEUd, GRADE 0, GRADE 15425365446
NEUd, GRADE 0, GRADE 21222123111
NEUd, GRADE 0, GRADE 30102100100
NEUd, GRADE 1, GRADE 01200010000
NEUd, GRADE 1, GRADE 10200100101
NEUd, GRADE 1, GRADE 21001101110
NEUd, GRADE 2, GRADE 00010000001
NEUd, GRADE 2, GRADE 10000000200
NEUd, GRADE 2, GRADE 20000100011
NEUd, GRADE 3, GRADE 10000100000
PLTCd, UNKNOWN, GRADE 00100001011
PLTCd, GRADE 0, UNKNOWN0000001000
PLTCd, GRADE 0, GRADE 042454443464443454445
PLTCd, GRADE 0, GRADE 12000010100
PLTCd, GRADE 0, GRADE 20011010000
PLTCd, GRADE 1, GRADE 00001000100
PLTCd, GRADE 1, GRADE 30001000000
PLTCd, GRADE 2, GRADE 20000000010
WBCd, UNKNOWN, GRADE 00100001010
WBCd, UNKNOWN, GRADE 10000000011
WBCd, GRADE 0, UNKNOWN0000001000
WBCd, GRADE 0, GRADE 039424140414642413841
WBCd, GRADE 0, GRADE 14336201344
WBCd, GRADE 0, GRADE 20000100000
WBCd, GRADE 1, GRADE 00010100210
WBCd, GRADE 1, GRADE 11000000110
WBCd, GRADE 2, GRADE 10000100000
WBCi, UNKNOWN, GRADE 00100001021
WBCi, GRADE 0, UNKNOWN0000001000
WBCi, GRADE 0, GRADE 037384037434335373636
WBCi, GRADE 0, GRADE 15546235637
WBCi, GRADE 0, GRADE 20001001101
WBCi, GRADE 0, GRADE 30000000010
WBCi, GRADE 1, GRADE 00001100110
WBCi, GRADE 1, GRADE 11211002211
WBCi, GRADE 1, GRADE 21000000010
WBCi, GRADE 2, GRADE 10000000010
PrimaryNumber of Subjects With Any Medically-attended Adverse Events (MAEs)

MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Time frame:
During the entire study period (from Day 1 up to Month 26)
Reported as:
Count of participants · Participants
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Subjects With Any Medically-attended Adverse Events (MAEs)21162023211419182320
PrimaryNumber of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Time frame:
During the entire study period (from Day 1 up to Month 26)
Reported as:
Count of participants · Participants
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)0000001000
PrimaryNumber of Subjects With Serious Adverse Events (SAEs).

SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame:
During the entire study period (from Day 1 up to Month 26)
Reported as:
Count of participants · Participants
Number of Subjects With Serious Adverse Events (SAEs).
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Subjects With Serious Adverse Events (SAEs).2112220223
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).

Time frame:
At Day 1
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 1
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)- Day 145464747484747464445
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

Time frame:
At Day 29
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 29
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 2943404140424237413940
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

Time frame:
At Day 85
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 85
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Day 8539363435393534343538
PrimaryConcentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1

Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

Time frame:
At Day 1
Reported as:
Geometric mean · EL.U/mL
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 1
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 18887.9 (7004.9 to 11277.1)8719.3 (6547.0 to 11612.3)9691 (7593.7 to 12367.7)9121 (7180.0 to 11586.6)9948.6 (8106.2 to 12209.8)8555.5 (6980.1 to 10486.4)9019.6 (7263.5 to 11200.2)9278.2 (7430.7 to 11585.1)9039.3 (6930.7 to 11789.5)9160 (7225.7 to 11612.2)
PrimaryConcentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

Time frame:
At Day 29
Reported as:
Geometric mean · EL.U/mL
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 29112973.2 (90888.2 to 140424.5)45645 (35289.4 to 59039.5)116596.8 (93869.6 to 144826.6)61634.2 (49810.3 to 76264.7)46596.2 (38306.7 to 56679.5)67114.6 (54649.7 to 82422.6)35580.2 (24654.2 to 51348.2)20398.6 (16362.4 to 25430.5)36426.2 (29124.8 to 45558.0)21938.1 (18037.8 to 26681.8)
PrimaryConcentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

Time frame:
At Day 85
Reported as:
Geometric mean · EL.U/mL
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 85
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Day 8545351.6 (36766.7 to 55941.1)28437.5 (21623.4 to 37398.9)74639.7 (59986.3 to 92872.6)30419.3 (23619.9 to 39176.0)25718.6 (20748.8 to 31878.8)48775.9 (40697.7 to 58457.7)28617.8 (19448.1 to 42110.9)15105.9 (12007.7 to 19003.6)37911.4 (30149.4 to 47671.7)16749.9 (13471.8 to 20825.8)
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1

Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

Time frame:
At Day 1
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 1
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by Microneutralization (MN) Assay - Day 132343536334037343133
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29

Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

Time frame:
At Day 29
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 29
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 2943404040414136413740
PrimaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85

Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

Time frame:
At Day 85
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 85
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by MN Assay - Day 8536353431383530323537
PrimaryTiters for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

Time frame:
At Day 1
Reported as:
Geometric mean · Titer
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 1
TiterD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 140.6 (29.4 to 56.1)45.4 (33.4 to 61.6)45.9 (34.2 to 61.8)45.8 (34.5 to 60.8)41.9 (30.7 to 57.3)45.1 (35.0 to 58.2)44.6 (34.4 to 57.7)43.4 (32.4 to 58.0)42.7 (31.2 to 58.6)38 (28.8 to 50.2)
PrimaryTiters for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

Time frame:
At Day 29
Reported as:
Geometric mean · Titer
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29
TiterD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 29100.3 (88.1 to 114.1)109.3 (94.0 to 127.0)113.1 (96.5 to 132.6)105.6 (91.0 to 122.5)96.4 (83.2 to 111.6)89.8 (73.0 to 110.5)86.2 (69.9 to 106.3)80 (66.6 to 96.1)74.5 (59.6 to 93.2)87.2 (75.6 to 100.7)
PrimaryTiters for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

Time frame:
At Day 85
Reported as:
Geometric mean · Titer
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 85
TiterD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Titers for Serum H1 Stalk Antibodies Measured by MN Assay - Day 8573 (58.3 to 91.5)98.9 (81.5 to 119.9)122.7 (108.9 to 138.3)59.6 (45.9 to 77.4)87.4 (71.1 to 107.6)109.8 (93.0 to 129.8)55.4 (41.3 to 74.3)75.3 (56.4 to 100.4)88.3 (74.2 to 105.2)86.1 (70.2 to 105.5)
PrimaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 2988.4 (74.9 to 96.1)60 (43.3 to 75.1)87.8 (73.8 to 95.9)70 (53.5 to 83.4)52.4 (36.4 to 68.0)83.3 (68.6 to 93.0)35.1 (20.2 to 52.5)24.4 (12.4 to 40.3)38.5 (23.4 to 55.4)15 (5.7 to 29.8)
PrimaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 8551.3 (34.8 to 67.6)44.4 (27.9 to 61.9)79.4 (62.1 to 91.3)37.1 (21.5 to 55.1)20.5 (9.3 to 36.5)80 (63.1 to 91.6)29.4 (15.1 to 47.5)8.8 (1.9 to 23.7)37.1 (21.5 to 55.1)7.9 (1.7 to 21.4)
PrimaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 2940.5 (25.6 to 56.7)39.5 (24.0 to 56.6)31.6 (17.5 to 48.7)41 (25.6 to 57.9)36.8 (21.8 to 54.0)31.7 (18.1 to 48.1)34.3 (19.1 to 52.2)26.3 (13.4 to 43.1)29.7 (15.9 to 47.0)36.1 (20.8 to 53.8)
PrimaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 8529.7 (15.9 to 47.0)38.2 (22.2 to 56.4)34.4 (18.6 to 53.2)15.2 (5.1 to 31.9)31.4 (16.9 to 49.3)41.2 (24.6 to 59.3)21.2 (9.0 to 38.9)18.8 (7.2 to 36.4)33.3 (18.0 to 51.8)41.2 (24.6 to 59.3)
PrimaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 2958.1 (42.1 to 73.0)35 (20.6 to 51.7)61 (44.5 to 75.8)30 (16.6 to 46.5)21.4 (10.3 to 36.8)42.9 (27.7 to 59.0)13.5 (4.5 to 28.8)2.4 (0.1 to 12.9)15.4 (5.9 to 30.5)2.5 (0.1 to 13.2)
PrimaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 8512.8 (4.3 to 27.4)5.6 (0.7 to 18.7)47.1 (29.8 to 64.9)17.1 (6.6 to 33.6)5.1 (0.6 to 17.3)25.7 (12.5 to 43.3)17.6 (6.8 to 34.5)2.9 (0.1 to 15.3)14.3 (4.8 to 30.3)5.3 (0.6 to 17.7)
PrimaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 29
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 297.1 (1.5 to 19.5)7.9 (1.7 to 21.4)10.5 (2.9 to 24.8)5.1 (0.6 to 17.3)7.9 (1.7 to 21.4)4.9 (0.6 to 16.5)8.6 (1.8 to 23.1)2.6 (0.1 to 13.8)2.7 (0.1 to 14.2)2.8 (0.1 to 14.5)
PrimaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 85
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Titer Measured by MN Assay - Day 852.7 (0.1 to 14.2)8.8 (1.9 to 23.7)15.6 (5.3 to 32.8)3 (0.1 to 15.8)8.6 (1.8 to 23.1)8.8 (1.9 to 23.7)0 (0.0 to 10.6)6.3 (0.8 to 20.8)3 (0.1 to 15.8)2.9 (0.1 to 15.3)
PrimaryMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Geometric mean · Ratio
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 29
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 2912.4 (9.2 to 16.7)5.9 (4.4 to 8.0)12.6 (9.2 to 17.1)6.8 (4.9 to 9.5)4.7 (3.6 to 6.2)8.1 (6.2 to 10.5)4.2 (2.9 to 6.2)2.3 (1.8 to 3.0)3.9 (2.8 to 5.4)2.4 (1.9 to 2.9)
PrimaryMGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 85
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
MGI for Anti-H1 Stalk Antibody Concentration Measured by ELISA - Day 855 (3.9 to 6.5)3.4 (2.6 to 4.5)8.1 (6.1 to 10.8)3.4 (2.4 to 4.9)2.6 (2.1 to 3.2)6.3 (5.0 to 7.9)3.4 (2.3 to 5.0)1.7 (1.4 to 2.1)3.8 (2.7 to 5.5)1.8 (1.5 to 2.3)
PrimaryMGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29

MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

Time frame:
At Day 29, compared to pre-vaccination at Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 29
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 292.4 (1.7 to 3.3)2.6 (1.9 to 3.6)2.4 (1.8 to 3.3)2.3 (1.7 to 3.2)2.3 (1.7 to 3.2)2 (1.5 to 2.7)2.3 (1.7 to 3.2)1.9 (1.4 to 2.5)1.7 (1.2 to 2.4)2.2 (1.6 to 3.1)
PrimaryMGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85

MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

Time frame:
At Day 85, compared to pre-vaccination at Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 85
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
MGI for Anti-H1 Stalk Antibody Titer Measured by MN Assay - Day 851.6 (1.2 to 2.2)2.2 (1.5 to 3.2)2.5 (1.7 to 3.7)1.1 (0.8 to 1.6)2 (1.5 to 2.8)2.5 (1.7 to 3.5)1.2 (0.9 to 1.7)1.6 (1.1 to 2.2)2 (1.4 to 2.8)2.4 (1.7 to 3.3)
SecondaryAdjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA

The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.

Time frame:
28 days post priming dose(s) i.e. at Day 29 for 1 priming dose groups and at Day 85 for 2 priming doses groups
Reported as:
Geometric mean · EL.U/mL
Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Adjusted GMCs for Anti-H1 HA Stalk Antibody Measured by ELISA112206.4 (91362.2 to 137806.3)47432.6 (38317.4 to 58716.2)73945.6 (58686.6 to 93172.2)61356.7 (49582.3 to 75927)45346.6 (36827 to 55837.2)50602.8 (40283.4 to 63565.8)36159.3 (28972.3 to 45129)20403.5 (16531.4 to 25182.7)36826.9 (29320 to 46255.8)21675.2 (17515.2 to 26823.1)
Statistical analysis
  • D-SUIV Adjuvanted Group 1 vs D-SUIV Unadjuvanted Group 1 · Dunnett's t test · Gmc ratio: 2.47 · 94.46% CI 2.06 to 2.95Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,
  • D-SUIV Adjuvanted Group 4 vs D-SUIV Unadjuvanted Group 1 · Dunnett's t test · Gmc ratio: 1.75 · 94.46% CI 1.46 to 2.1Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,
SecondaryConcentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

Time frame:
At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Reported as:
Geometric mean · EL.U/mL
Concentrations of Serum H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
M827068.3 (21884.3 to 33480.4)17155.9 (13158.7 to 22367.4)41759.7 (32814.0 to 53144.1)18915.3 (15026.4 to 23810.7)15092.4 (12226.1 to 18630.8)25279.1 (20711.4 to 30854.2)19028.4 (13706.8 to 26416.0)11024.8 (8751.5 to 13888.6)22359.8 (18089.1 to 27638.8)13142.1 (10306.0 to 16758.7)
M1422687.1 (18078.5 to 28470.4)17662.4 (14339.6 to 21755.1)37282.2 (29437.7 to 47216.9)20146.8 (15305.9 to 26518.8)16645.4 (12389.7 to 22362.8)24615 (19677.5 to 30791.4)16969.8 (11848.5 to 24304.6)10820.3 (8524.9 to 13733.9)22791.5 (17767.3 to 29236.4)12458.4 (9721.6 to 15965.7)
M14+28 days49594 (39888.4 to 61661.1)92885.6 (73985.7 to 116613.7)73078 (62288.9 to 85736.0)36709.7 (30186.1 to 44643.2)75155.7 (56729.2 to 99567.4)52026.4 (42254.7 to 64057.8)22653.6 (16071.5 to 31931.4)29508.2 (21062.2 to 41341.1)38364 (30403.9 to 48408.1)17593.3 (13932.1 to 22216.6)
M2027648.6 (22712.3 to 33657.7)36133.6 (29063.7 to 44923.2)38120.3 (30433.7 to 47748.2)21916.1 (17219.1 to 27894.4)31396.4 (24953.9 to 39502.2)29988.8 (24033.9 to 37419.1)18408.1 (12608.3 to 26875.7)16632.9 (12484.8 to 22159.2)23145.3 (18447.2 to 29039.9)12635.2 (9489.2 to 16824.1)
M2622850.2 (18790.0 to 27787.8)29027.2 (23343.2 to 36095.3)32635.4 (26013.9 to 40942.3)18266 (14093.9 to 23673.1)27491.3 (20448.3 to 36960.2)25059.4 (19893.4 to 31567.0)18220.9 (12067.9 to 27511.0)14269 (10104.9 to 20149.0)21673.7 (17482.9 to 26869.2)12050.6 (8943.4 to 16237.5)
SecondaryNumber of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

Time frame:
At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26.
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1 Stalk Antibodies Measured by ELISA- Month 8 to 26
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
M839343027363330343334
M1435322626313125303031
M14+28 days28312325292922262729
M2029302424312720272725
M2629292221252520252523
SecondaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
M823.1 (11.1 to 39.3)23.5 (10.7 to 41.2)53.3 (34.3 to 71.7)14.8 (4.2 to 33.7)5.6 (0.7 to 18.7)39.4 (22.9 to 57.9)23.3 (9.9 to 42.3)8.8 (1.9 to 23.7)21.2 (9.0 to 38.9)0 (0.0 to 10.3)
M1420 (8.4 to 36.9)25 (11.5 to 43.4)50 (29.9 to 70.1)30.8 (14.3 to 51.8)9.7 (2.0 to 25.8)38.7 (21.8 to 57.8)12 (2.5 to 31.2)3.3 (0.1 to 17.2)13.3 (3.8 to 30.7)0 (0.0 to 11.2)
M14+28 days46.4 (27.5 to 66.1)83.9 (66.3 to 94.5)82.6 (61.2 to 95.0)44 (24.4 to 65.1)69 (49.2 to 84.7)75.9 (56.5 to 89.7)22.7 (7.8 to 45.4)38.5 (20.2 to 59.4)33.3 (16.5 to 54.0)10.3 (2.2 to 27.4)
M2027.6 (12.7 to 47.2)60 (40.6 to 77.3)50 (29.1 to 70.9)33.3 (15.6 to 55.3)38.7 (21.8 to 57.8)48.1 (28.7 to 68.1)20 (5.7 to 43.7)11.1 (2.4 to 29.2)25.9 (11.1 to 46.3)0 (0.0 to 13.7)
M2620.7 (8.0 to 39.7)41.4 (23.5 to 61.1)36.4 (17.2 to 59.3)28.6 (11.3 to 52.2)32 (14.9 to 53.5)36 (18.0 to 57.5)15 (3.2 to 37.9)8 (1.0 to 26.0)24 (9.4 to 45.1)0 (0.0 to 14.8)
SecondaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

Time frame:
At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1 Stalk Antibody Concentration, Measured by ELISA - Month 8 to 26.
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
M87.7 (1.6 to 20.9)0 (0.0 to 10.3)23.3 (9.9 to 42.3)7.4 (0.9 to 24.3)0 (0.0 to 9.7)9.1 (1.9 to 24.3)10 (2.1 to 26.5)0 (0.0 to 10.3)9.1 (1.9 to 24.3)0 (0.0 to 10.3)
M145.7 (0.7 to 19.2)3.1 (0.1 to 16.2)30.8 (14.3 to 51.8)3.8 (0.1 to 19.6)3.2 (0.1 to 16.7)3.2 (0.1 to 16.7)4 (0.1 to 20.4)0 (0.0 to 11.6)10 (2.1 to 26.5)0 (0.0 to 11.2)
M14+28 days17.9 (6.1 to 36.9)58.1 (39.1 to 75.5)52.2 (30.6 to 73.2)24 (9.4 to 45.1)37.9 (20.7 to 57.7)34.5 (17.9 to 54.3)4.5 (0.1 to 22.8)11.5 (2.4 to 30.2)18.5 (6.3 to 38.1)0 (0.0 to 11.9)
M2010.3 (2.2 to 27.4)26.7 (12.3 to 45.9)16.7 (4.7 to 37.4)8.3 (1.0 to 27.0)9.7 (2.0 to 25.8)11.1 (2.4 to 29.2)5 (0.1 to 24.9)3.7 (0.1 to 19.0)11.1 (2.4 to 29.2)0 (0.0 to 13.7)
M263.4 (0.1 to 17.8)13.8 (3.9 to 31.7)4.5 (0.1 to 22.8)4.8 (0.1 to 23.8)4 (0.1 to 20.4)12 (2.5 to 31.2)10 (1.2 to 31.7)4 (0.1 to 20.4)12 (2.5 to 31.2)0 (0.0 to 14.8)
SecondaryMGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

Time frame:
At Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H1 Stalk Antibody Measured by ELISA - Month 8 to 26
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
M82.9 (2.2 to 3.7)2.3 (1.8 to 2.9)4.7 (3.5 to 6.3)2 (1.4 to 2.8)1.4 (1.2 to 1.8)3.3 (2.6 to 4.3)2.2 (1.5 to 3.1)1.3 (1.1 to 1.7)2.4 (1.7 to 3.3)1.3 (1.1 to 1.5)
M142.5 (2.0 to 3.2)2.4 (1.8 to 3.2)4.7 (3.2 to 6.8)2.3 (1.7 to 3.2)1.6 (1.2 to 2.1)3.2 (2.5 to 4.2)2 (1.4 to 2.8)1.2 (1.0 to 1.5)2.1 (1.4 to 3.1)1.2 (1.0 to 1.4)
M14+28 days5.3 (3.7 to 7.7)12.6 (8.7 to 18.2)9.5 (6.6 to 13.6)4.3 (3.0 to 6.4)7.3 (5.0 to 10.7)7.1 (5.3 to 9.5)2.7 (2.0 to 3.8)3.4 (2.3 to 5.0)4.1 (2.6 to 6.3)1.7 (1.3 to 2.2)
M203 (2.3 to 3.8)4.9 (3.5 to 6.8)4.6 (3.3 to 6.3)2.6 (1.8 to 3.8)3.1 (2.3 to 4.1)4 (3.0 to 5.3)2.2 (1.5 to 3.2)1.8 (1.4 to 2.3)2.5 (1.7 to 3.6)1.3 (1.1 to 1.6)
M262.7 (2.0 to 3.5)3.7 (2.7 to 5.2)3.7 (2.7 to 5.2)2.3 (1.5 to 3.6)2.6 (1.9 to 3.7)3.3 (2.4 to 4.4)2.1 (1.4 to 3.3)1.5 (1.1 to 2.1)2.2 (1.5 to 3.3)1.3 (1.1 to 1.6)
SecondaryConcentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).

Time frame:
At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Reported as:
Geometric mean · EL.U/mL
Concentrations of Anti-H2 and Anti-H18 Antibodies Measured by ELISA
EL.U/mLD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Anti-H2, Day 15848.2 (4577.0 to 7472.5)5975.5 (4615.6 to 7736.1)6882.1 (5488.8 to 8629.2)5968.7 (4723.0 to 7542.9)6704 (5329.0 to 8433.8)5513.6 (4551.7 to 6678.7)6042.3 (4790.1 to 7622.0)5917.2 (4681.7 to 7478.9)6320.1 (4858.6 to 8221.2)5512.2 (4373.1 to 6948.0)
Anti-H2, Day 29111973.1 (90350.2 to 138770.8)28538 (22181.5 to 36716.0)115020.5 (93922.9 to 140857.1)59190.1 (46420.7 to 75472.2)30980 (25025.9 to 38350.8)64182.7 (50875.4 to 80970.8)30976.4 (20643.7 to 46481.0)12700 (10182.5 to 15839.8)33198.1 (25465.3 to 43279.1)10941.3 (8962.2 to 13357.5)
Anti-H2, Day 8542295.4 (34505.4 to 51844.2)18172.7 (13948.3 to 23676.6)60609.1 (47899.9 to 76690.5)26581.4 (19839.5 to 35614.4)16519.5 (13127.6 to 20787.9)39576.4 (31245.9 to 50128.0)23576.8 (15654.3 to 35508.7)9640.8 (7382.5 to 12590.1)29437.8 (22555.8 to 38419.7)8939.2 (7063.2 to 11313.4)
Anti-H2, M829904.9 (24015.3 to 37238.9)12923.2 (9816.8 to 17012.6)38258.4 (29536.3 to 49556.3)18259.9 (13789.8 to 24179.0)12402.4 (9535.4 to 16131.4)24555.6 (19235.1 to 31347.7)19264.5 (13044.6 to 28450.1)8229 (6456.6 to 10488.1)22379.6 (17763.5 to 28195.2)9409 (7202.0 to 12292.4)
Anti-H2, M1421754.4 (17375.9 to 27236.2)11417.4 (8969.1 to 14534.0)30670.3 (23748.7 to 39609.2)17100.4 (12454.3 to 23479.8)10899.7 (8122.1 to 14627.2)19573.6 (14935.3 to 25652.3)15050.2 (9969.1 to 22721.0)7717.7 (5839.8 to 10199.6)21978.5 (17171.0 to 28132.1)8582.5 (6443.9 to 11430.8)
Anti-H2, M14+28 days36459.1 (29419.5 to 45183.3)91778 (73053.9 to 115301.3)76909.5 (63594.4 to 93012.4)27256.3 (20573.9 to 36109.3)81616.2 (64374.2 to 103476.4)58542.1 (47219.6 to 72579.5)19172.9 (12543.2 to 29306.6)29940.3 (20765.3 to 43169.3)41953 (34398.2 to 51167.0)11753.1 (9023.9 to 15307.8)
Anti-H2, M2024198.7 (19291.6 to 30353.9)34266 (26622.0 to 44104.8)36950 (29306.1 to 46587.6)19456.7 (14167.4 to 26720.7)32287.4 (25257.3 to 41274.2)28818 (22130.7 to 37525.9)14269 (9295.0 to 21905.0)15780.8 (11287.6 to 22062.7)25006.7 (19478.3 to 32104.2)7961.8 (5712.7 to 11096.2)
Anti-H2, M2620136.5 (16257.6 to 24940.8)27000.7 (21059.5 to 34617.9)29403.8 (22530.7 to 38373.5)15358.6 (11070.7 to 21307.3)27477.2 (20295.7 to 37199.7)22917.6 (17205.8 to 30525.6)14906.4 (9433.3 to 23554.9)13186.7 (9162.6 to 18978.2)23570.6 (18496.4 to 30036.9)7708.3 (5593.3 to 10623.1)
Anti-H18, Day 14936.1 (3878.3 to 6282.3)4845.1 (3641.3 to 6446.9)5936.9 (4557.4 to 7734.1)5299.3 (4197.0 to 6691.1)5368.1 (4259.0 to 6766.0)4651.7 (3734.8 to 5793.7)4991.2 (4039.5 to 6167.0)5543.3 (4394.6 to 6992.4)5399.2 (4075.9 to 7152.3)5681.1 (4327.4 to 7458.4)
Anti-H18, Day 2926663.7 (21555.9 to 32981.8)19762.5 (15199.9 to 25694.6)30387.7 (25266.3 to 36547.2)19951 (16410.4 to 24255.6)21416.3 (17539.0 to 26150.8)19348 (16009.2 to 23383.0)13383.5 (9734.9 to 18399.5)10899.9 (8829.7 to 13455.5)14152.1 (11530.1 to 17370.3)11675.5 (9209.8 to 14801.4)
Anti-H18, Day 8513071 (10618.2 to 16090.3)13472.1 (10474.3 to 17327.9)27305.6 (22369.5 to 33330.8)10270.7 (8541.1 to 12350.5)12017.1 (9474.7 to 15241.8)17205.7 (14796.1 to 20007.7)10062.6 (7439.9 to 13610.1)8762.3 (6910.2 to 11110.9)15219.4 (12301.2 to 18829.9)9136.2 (6966.1 to 11982.3)
Anti-H18, M811992.9 (9665.8 to 14880.2)10240.6 (7932.7 to 13220.0)18529.9 (15273.7 to 22480.4)10260.8 (8094.5 to 13006.8)9973.8 (7709.1 to 12903.9)12753.8 (10434.4 to 15588.8)9988.8 (7297.7 to 13672.3)8182.1 (6517.6 to 10271.7)12617.3 (10198.5 to 15609.8)9590.3 (7160.5 to 12844.6)
Anti-H18, M149039.6 (7212.3 to 11329.9)8610.3 (6938.0 to 10685.6)14078.6 (11455.9 to 17301.7)8820.4 (6959.4 to 11179.1)8370.2 (6213.2 to 11276.0)10216.5 (8035.8 to 12989.1)8526.2 (6047.8 to 12020.2)6955.8 (5553.1 to 8713.0)11876.7 (9622.1 to 14659.6)8178.4 (6007.8 to 11133.2)
Anti-H18, M14+28 days19763.3 (15225.3 to 25653.9)26567.6 (21331.9 to 33088.4)20291 (17142.5 to 24017.8)15768 (12672.2 to 19620.0)24020.6 (19157.0 to 30118.9)15872.3 (12888.2 to 19547.3)11742.6 (8553.4 to 16120.9)12543.5 (9593.4 to 16400.7)14564 (12163.0 to 17439.0)10758.1 (8190.4 to 14130.7)
Anti-H18, M2012192 (9446.1 to 15736.1)14228.2 (11276.5 to 17952.5)13068.8 (10894.9 to 15676.5)10503.1 (8169.3 to 13503.6)12541.2 (9836.1 to 15990.2)10695.2 (8464.7 to 13513.5)9695.4 (6545.1 to 14362.2)8934.7 (6832.5 to 11683.6)12302.2 (9853.6 to 15359.2)7764.5 (5518.3 to 10925.1)
Anti-H18, M2610832.8 (8488.3 to 13825.0)11823.4 (9575.2 to 14599.4)12186.4 (9948.2 to 14928.2)9767.9 (7407.6 to 12880.1)11445.8 (8371.9 to 15648.3)9308.8 (7285.1 to 11894.6)10283.6 (6627.6 to 15956.4)7937 (5903.9 to 10670.1)11617.9 (8948.6 to 15083.3)7646.4 (5326.5 to 10976.9)
SecondaryNumber of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA

Anti-H2 and anti-H18 immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 22 EL.U/mL (H2) and 43 EL.U/mL (H18).

Time frame:
At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H2 and Anti-H18 Antibodies Measured by ELISA
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Anti-H2, Day 145464747484747464445
Anti-H2, Day 2943404140424237413940
Anti-H2, Day 8539363435393534343538
Anti-H2, M839343027363330343334
Anti-H2, M1435322626313125303031
Anti-H2, M14+28 days28312325292922262729
Anti-H2, M2029302424312720272725
Anti-H2, M2629292221252520252523
Anti-H18, Day 145464647484747464445
Anti-H18, Day 2943404140424237413940
Anti-H18, Day 8539363435393534343538
Anti-H18, M839343027363330343334
Anti-H18, M1435322626313125303031
Anti-H18, M14+28 days28312325292922262729
Anti-H18, M2029302424312720272725
Anti-H18, M2629292221252520252523
SecondaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA

Percentage of subjects with a ≥ 4-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .

Time frame:
At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Anti-H2, Day 2995.3 (84.2 to 99.4)62.5 (45.8 to 77.3)92.7 (80.1 to 98.5)82.5 (67.2 to 92.7)57.1 (41.0 to 72.3)90.5 (77.4 to 97.3)62.2 (44.8 to 77.5)26.8 (14.2 to 42.9)48.7 (32.4 to 65.2)12.5 (4.2 to 26.8)
Anti-H2, Day 8566.7 (49.8 to 80.9)36.1 (20.8 to 53.8)79.4 (62.1 to 91.3)45.7 (28.8 to 63.4)17.9 (7.5 to 33.5)77.1 (59.9 to 89.6)35.3 (19.7 to 53.5)2.9 (0.1 to 15.3)42.9 (26.3 to 60.6)5.3 (0.6 to 17.7)
Anti-H2, M851.3 (34.8 to 67.6)23.5 (10.7 to 41.2)73.3 (54.1 to 87.7)29.6 (13.8 to 50.2)8.3 (1.8 to 22.5)69.7 (51.3 to 84.4)26.7 (12.3 to 45.9)5.9 (0.7 to 19.7)33.3 (18.0 to 51.8)0 (0.0 to 10.3)
Anti-H2, M1434.3 (19.1 to 52.2)15.6 (5.3 to 32.8)61.5 (40.6 to 79.8)30.8 (14.3 to 51.8)6.5 (0.8 to 21.4)58.1 (39.1 to 75.5)16 (4.5 to 36.1)3.3 (0.1 to 17.2)23.3 (9.9 to 42.3)0 (0.0 to 11.2)
Anti-H2, M14+28 days57.1 (37.2 to 75.5)100 (88.8 to 100.0)100 (85.2 to 100.0)52 (31.3 to 72.2)82.8 (64.2 to 94.2)96.6 (82.2 to 99.9)36.4 (17.2 to 59.3)50 (29.9 to 70.1)63 (42.4 to 80.6)6.9 (0.8 to 22.8)
Anti-H2, M2041.4 (23.5 to 61.1)70 (50.6 to 85.3)75 (53.3 to 90.2)41.7 (22.1 to 63.4)54.8 (36.0 to 72.7)74.1 (53.7 to 88.9)20 (5.7 to 43.7)18.5 (6.3 to 38.1)37 (19.4 to 57.6)4 (0.1 to 20.4)
Anti-H2, M2641.4 (23.5 to 61.1)62.1 (42.3 to 79.3)54.5 (32.2 to 75.6)38.1 (18.1 to 61.6)48 (27.8 to 68.7)56 (34.9 to 75.6)20 (5.7 to 43.7)16 (4.5 to 36.1)32 (14.9 to 53.5)4.3 (0.1 to 21.9)
Anti-H18, Day 2955.8 (39.9 to 70.9)52.5 (36.1 to 68.5)50 (33.8 to 66.2)40 (24.9 to 56.7)45.2 (29.8 to 61.3)52.4 (36.4 to 68.0)21.6 (9.8 to 38.2)19.5 (8.8 to 34.9)20.5 (9.3 to 36.5)15 (5.7 to 29.8)
Anti-H18, Day 8517.9 (7.5 to 33.5)33.3 (18.6 to 51.0)48.5 (30.8 to 66.5)14.3 (4.8 to 30.3)20.5 (9.3 to 36.5)48.6 (31.4 to 66.0)14.7 (5.0 to 31.1)5.9 (0.7 to 19.7)25.7 (12.5 to 43.3)5.3 (0.6 to 17.7)
Anti-H18, M812.8 (4.3 to 27.4)20.6 (8.7 to 37.9)44.8 (26.4 to 64.3)11.1 (2.4 to 29.2)11.1 (3.1 to 26.1)39.4 (22.9 to 57.9)16.7 (5.6 to 34.7)11.8 (3.3 to 27.5)24.2 (11.1 to 42.3)0 (0.0 to 10.3)
Anti-H18, M148.6 (1.8 to 23.1)21.9 (9.3 to 40.0)36 (18.0 to 57.5)11.5 (2.4 to 30.2)6.5 (0.8 to 21.4)29 (14.2 to 48.0)8 (1.0 to 26.0)3.3 (0.1 to 17.2)13.3 (3.8 to 30.7)0 (0.0 to 11.2)
Anti-H18, M14+28 days35.7 (18.6 to 55.9)71 (52.0 to 85.8)54.5 (32.2 to 75.6)36 (18.0 to 57.5)55.2 (35.7 to 73.6)55.2 (35.7 to 73.6)18.2 (5.2 to 40.3)15.4 (4.4 to 34.9)25.9 (11.1 to 46.3)6.9 (0.8 to 22.8)
Anti-H18, M2020.7 (8.0 to 39.7)40 (22.7 to 59.4)30.4 (13.2 to 52.9)20.8 (7.1 to 42.2)19.4 (7.5 to 37.5)29.6 (13.8 to 50.2)5 (0.1 to 24.9)7.4 (0.9 to 24.3)11.1 (2.4 to 29.2)4 (0.1 to 20.4)
Anti-H18, M2624.1 (10.3 to 43.5)31 (15.3 to 50.8)28.6 (11.3 to 52.2)23.8 (8.2 to 47.2)20 (6.8 to 40.7)12 (2.5 to 31.2)10 (1.2 to 31.7)8 (1.0 to 26.0)12 (2.5 to 31.2)0 (0.0 to 14.8)
SecondaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA

Percentage of subjects with a ≥ 10-fold increase of anti-H2 and anti-H18 antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA .

Time frame:
At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H2 and Anti-H18 Antibody Concentration Measured by ELISA
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Anti-H2, Day 2967.4 (51.5 to 80.9)15 (5.7 to 29.8)68.3 (51.9 to 81.9)42.5 (27.0 to 59.1)16.7 (7.0 to 31.4)61.9 (45.6 to 76.4)18.9 (8.0 to 35.2)2.4 (0.1 to 12.9)20.5 (9.3 to 36.5)2.5 (0.1 to 13.2)
Anti-H2, Day 8525.6 (13.0 to 42.1)5.6 (0.7 to 18.7)55.9 (37.9 to 72.8)22.9 (10.4 to 40.1)2.6 (0.1 to 13.5)48.6 (31.4 to 66.0)20.6 (8.7 to 37.9)2.9 (0.1 to 15.3)17.1 (6.6 to 33.6)5.3 (0.6 to 17.7)
Anti-H2, M815.4 (5.9 to 30.5)0 (0.0 to 10.3)26.7 (12.3 to 45.9)11.1 (2.4 to 29.2)0 (0.0 to 9.7)12.1 (3.4 to 28.2)16.7 (5.6 to 34.7)0 (0.0 to 10.3)15.2 (5.1 to 31.9)0 (0.0 to 10.3)
Anti-H2, M1414.3 (4.8 to 30.3)0 (0.0 to 10.9)23.1 (9.0 to 43.6)11.5 (2.4 to 30.2)0 (0.0 to 11.2)6.5 (0.8 to 21.4)8 (1.0 to 26.0)0 (0.0 to 11.6)10 (2.1 to 26.5)0 (0.0 to 11.2)
Anti-H2, M14+28 days25 (10.7 to 44.9)71 (52.0 to 85.8)65.2 (42.7 to 83.6)24 (9.4 to 45.1)48.3 (29.4 to 67.5)65.5 (45.7 to 82.1)9.1 (1.1 to 29.2)15.4 (4.4 to 34.9)22.2 (8.6 to 42.3)3.4 (0.1 to 17.8)
Anti-H2, M2013.8 (3.9 to 31.7)23.3 (9.9 to 42.3)25 (9.8 to 46.7)20.8 (7.1 to 42.2)25.8 (11.9 to 44.6)22.2 (8.6 to 42.3)5 (0.1 to 24.9)7.4 (0.9 to 24.3)11.1 (2.4 to 29.2)0 (0.0 to 13.7)
Anti-H2, M2613.8 (3.9 to 31.7)13.8 (3.9 to 31.7)18.2 (5.2 to 40.3)9.5 (1.2 to 30.4)24 (9.4 to 45.1)12 (2.5 to 31.2)10 (1.2 to 31.7)8 (1.0 to 26.0)12 (2.5 to 31.2)0 (0.0 to 14.8)
Anti-H18, Day 2923.3 (11.8 to 38.6)15 (5.7 to 29.8)25 (12.7 to 41.2)12.5 (4.2 to 26.8)16.7 (7.0 to 31.4)16.7 (7.0 to 31.4)8.1 (1.7 to 21.9)2.4 (0.1 to 12.9)7.7 (1.6 to 20.9)2.5 (0.1 to 13.2)
Anti-H18, Day 857.7 (1.6 to 20.9)2.8 (0.1 to 14.5)24.2 (11.1 to 42.3)5.7 (0.7 to 19.2)2.6 (0.1 to 13.5)5.7 (0.7 to 19.2)2.9 (0.1 to 15.3)2.9 (0.1 to 15.3)11.4 (3.2 to 26.7)5.3 (0.6 to 17.7)
Anti-H18, M82.6 (0.1 to 13.5)0 (0.0 to 10.3)6.9 (0.8 to 22.8)3.7 (0.1 to 19.0)0 (0.0 to 9.7)3 (0.1 to 15.8)6.7 (0.8 to 22.1)2.9 (0.1 to 15.3)9.1 (1.9 to 24.3)0 (0.0 to 10.3)
Anti-H18, M140 (0.0 to 10.0)0 (0.0 to 10.9)12 (2.5 to 31.2)3.8 (0.1 to 19.6)0 (0.0 to 11.2)0 (0.0 to 11.2)4 (0.1 to 20.4)0 (0.0 to 11.6)10 (2.1 to 26.5)0 (0.0 to 11.2)
Anti-H18, M14+28 days17.9 (6.1 to 36.9)25.8 (11.9 to 44.6)18.2 (5.2 to 40.3)12 (2.5 to 31.2)17.2 (5.8 to 35.8)3.4 (0.1 to 17.8)4.5 (0.1 to 22.8)7.7 (0.9 to 25.1)11.1 (2.4 to 29.2)0 (0.0 to 11.9)
Anti-H18, M206.9 (0.8 to 22.8)13.3 (3.8 to 30.7)4.3 (0.1 to 21.9)4.2 (0.1 to 21.1)6.5 (0.8 to 21.4)0 (0.0 to 12.8)5 (0.1 to 24.9)3.7 (0.1 to 19.0)11.1 (2.4 to 29.2)0 (0.0 to 13.7)
Anti-H18, M266.9 (0.8 to 22.8)10.3 (2.2 to 27.4)4.8 (0.1 to 23.8)4.8 (0.1 to 23.8)8 (1.0 to 26.0)0 (0.0 to 13.7)10 (1.2 to 31.7)0 (0.0 to 13.7)8 (1.0 to 26.0)0 (0.0 to 14.8)
SecondaryMGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1.

Time frame:
At Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26, compared to Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H2 and Anti-H18 Antibodies Concentrations Measured by ELISA
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Anti-H2, Day 2918.4 (13.6 to 24.9)5.3 (4.0 to 7.0)17.3 (12.9 to 23.1)9.9 (7.0 to 14.0)4.7 (3.7 to 6.0)12.3 (9.2 to 16.3)5.6 (3.8 to 8.1)2.3 (1.8 to 2.9)5 (3.5 to 7.0)1.9 (1.6 to 2.3)
Anti-H2, Day 857 (5.2 to 9.2)3.2 (2.5 to 4.2)9.5 (7.2 to 12.5)4.4 (3.0 to 6.5)2.4 (2.0 to 2.9)8.2 (6.3 to 10.7)4.1 (2.8 to 5.8)1.7 (1.4 to 2.0)4.2 (2.9 to 6.1)1.6 (1.3 to 1.9)
Anti-H2, M84.8 (3.7 to 6.2)2.4 (1.9 to 2.9)6.2 (4.6 to 8.4)3.1 (2.1 to 4.4)1.8 (1.5 to 2.1)5.2 (4.0 to 6.6)3.3 (2.2 to 4.9)1.5 (1.3 to 1.8)3.3 (2.3 to 4.7)1.5 (1.3 to 1.7)
Anti-H2, M143.6 (2.8 to 4.7)2.2 (1.8 to 2.6)5.6 (3.9 to 8.1)3.1 (2.1 to 4.5)1.6 (1.4 to 2.0)4.1 (3.3 to 5.3)2.5 (1.8 to 3.6)1.4 (1.2 to 1.7)2.8 (2.0 to 4.0)1.4 (1.2 to 1.6)
Anti-H2, M14+28 days6.1 (4.3 to 8.7)17.2 (12.5 to 23.8)14.7 (10.4 to 20.8)5.1 (3.4 to 7.7)12.1 (8.0 to 18.3)12.6 (9.7 to 16.2)3.3 (2.3 to 4.8)5.6 (3.7 to 8.4)6.1 (4.2 to 8.9)1.9 (1.5 to 2.3)
Anti-H2, M203.9 (3.0 to 5.1)6.4 (4.8 to 8.7)6.5 (4.6 to 9.0)3.6 (2.4 to 5.3)4.8 (3.4 to 6.9)6.2 (4.8 to 8.0)2.5 (1.7 to 3.6)2.7 (1.9 to 3.9)3.7 (2.6 to 5.2)1.3 (1.1 to 1.6)
Anti-H2, M263.5 (2.7 to 4.6)5 (3.7 to 6.7)5 (3.5 to 7.1)3 (2.0 to 4.7)4.2 (2.8 to 6.1)4.9 (3.7 to 6.5)2.6 (1.7 to 3.9)2.3 (1.6 to 3.4)3.2 (2.2 to 4.6)1.4 (1.2 to 1.6)
Anti-H18, Day 295.2 (3.9 to 6.9)4.6 (3.5 to 6.0)5.3 (3.8 to 7.3)3.7 (2.8 to 4.9)4.1 (3.2 to 5.3)4.3 (3.3 to 5.6)2.7 (2.0 to 3.7)2.1 (1.7 to 2.7)2.5 (1.9 to 3.3)2 (1.7 to 2.4)
Anti-H18, Day 852.6 (2.1 to 3.3)2.9 (2.2 to 3.7)4.9 (3.7 to 6.5)2 (1.5 to 2.7)2.2 (1.8 to 2.7)4.3 (3.4 to 5.3)2 (1.5 to 2.7)1.6 (1.4 to 2.0)2.6 (1.9 to 3.6)1.6 (1.3 to 1.9)
Anti-H18, M82.4 (1.9 to 2.9)2.4 (1.9 to 3.0)3.5 (2.6 to 4.6)1.8 (1.4 to 2.4)1.8 (1.5 to 2.2)3.2 (2.6 to 3.9)2 (1.5 to 2.7)1.6 (1.3 to 2.0)2.3 (1.7 to 3.2)1.5 (1.3 to 1.7)
Anti-H18, M141.9 (1.5 to 2.2)2.1 (1.7 to 2.6)3.1 (2.3 to 4.4)1.8 (1.3 to 2.4)1.6 (1.3 to 2.0)2.6 (2.1 to 3.3)1.7 (1.2 to 2.3)1.3 (1.1 to 1.5)1.9 (1.4 to 2.5)1.3 (1.1 to 1.5)
Anti-H18, M14+28 days4.1 (2.9 to 5.7)6.4 (4.6 to 9.0)4.6 (3.1 to 6.6)3.3 (2.3 to 4.7)4.4 (3.3 to 5.9)4.3 (3.4 to 5.3)2.4 (1.8 to 3.3)2.4 (1.8 to 3.2)2.6 (1.8 to 3.6)1.7 (1.3 to 2.1)
Anti-H18, M202.5 (1.9 to 3.1)3.5 (2.6 to 4.8)2.7 (2.0 to 3.8)2.2 (1.6 to 3.1)2.4 (1.9 to 3.1)2.8 (2.3 to 3.5)2 (1.4 to 2.8)1.6 (1.3 to 2.0)2.1 (1.6 to 2.9)1.3 (1.1 to 1.6)
Anti-H18, M262.4 (1.8 to 3.0)2.9 (2.1 to 3.9)2.4 (1.7 to 3.4)2.1 (1.5 to 3.1)2.2 (1.6 to 3.0)2.5 (2.0 to 3.1)2.1 (1.4 to 3.2)1.4 (1.1 to 1.8)1.9 (1.3 to 2.8)1.4 (1.2 to 1.6)
SecondaryTiters for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL

Time frame:
At Days 1, 29 and 85
Reported as:
Geometric mean · Titer
Titers for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Anti-bodies Measured by MN Assay
TiterD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Day 158.8 (45.6 to 75.7)61 (47.8 to 77.8)62.9 (50.8 to 77.8)51.7 (39.5 to 67.6)53.7 (42.6 to 67.7)56.2 (44.5 to 70.8)56.2 (45.6 to 69.1)70.9 (57.3 to 87.8)56.6 (45.2 to 70.8)60.6 (48.9 to 75.2)
Day 2984 (68.8 to 102.5)93.5 (76.7 to 113.9)87.2 (77.0 to 98.8)84.3 (74.2 to 95.7)93.1 (82.2 to 105.5)80 (67.8 to 94.4)71.5 (59.4 to 86.0)78.7 (64.9 to 95.4)69.4 (54.1 to 88.9)103.7 (88.0 to 122.3)
Day 8565.8 (49.6 to 87.2)89.8 (73.7 to 109.5)96.1 (83.8 to 110.2)56 (45.3 to 69.2)81.5 (68.1 to 97.5)86.6 (73.7 to 101.7)63.9 (51.7 to 79.1)68 (52.8 to 87.5)84.9 (72.6 to 99.3)99.6 (78.5 to 126.3)
SecondaryNumber of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay

Anti-H1N1 swine influenza and anti-IIV4-H1N1 immune response measured by MN assay. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: cut-off = 20 1/DIL.

Time frame:
At Days 1, 29 and 85
Reported as:
Count of participants · Participants
Number of Seropositive Subjects for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Measured by MN Assay
ParticipantsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Day 140414338424244434243
Day 2942394040414237403640
Day 8536353434383534323537
SecondaryPercentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay

Percentage of subjects with a ≥ 4-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 29 and Day 85, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 4-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Day 299.3 (2.6 to 22.1)22.5 (10.8 to 38.5)7.7 (1.6 to 20.9)23.1 (11.1 to 39.3)24.4 (12.4 to 40.3)9.5 (2.7 to 22.6)10.8 (3.0 to 25.4)2.4 (0.1 to 12.9)7.7 (1.6 to 20.9)15 (5.7 to 29.8)
Day 855.1 (0.6 to 17.3)16.7 (6.4 to 32.8)18.2 (7.0 to 35.5)5.9 (0.7 to 19.7)21.1 (9.6 to 37.3)14.3 (4.8 to 30.3)5.9 (0.7 to 19.7)0 (0.0 to 10.3)8.6 (1.8 to 23.1)15.8 (6.0 to 31.3)
SecondaryPercentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay

Percentage of subjects with a ≥ 10-fold increase of anti-H1N1 swine influenza and anti-IIV4-H1N1 antibody titers, from Day 1, is calculated with exact 95% CI by MN assay.

Time frame:
At Day 29 and Day 85, compared to Day 1
Reported as:
Number · Percentage of subjects
Percentage of Subjects With a ≥ 10-fold Increase of Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibody Titers Measured by MN Assay
Percentage of subjectsD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Day 292.3 (0.1 to 12.3)2.5 (0.1 to 13.2)0 (0.0 to 9.0)0 (0.0 to 9.0)0 (0.0 to 8.6)0 (0.0 to 8.4)0 (0.0 to 9.5)0 (0.0 to 8.6)0 (0.0 to 9.0)0 (0.0 to 8.8)
Day 850 (0.0 to 9.0)2.8 (0.1 to 14.5)3 (0.1 to 15.8)0 (0.0 to 10.3)0 (0.0 to 9.3)2.9 (0.1 to 14.9)0 (0.0 to 10.3)0 (0.0 to 10.3)0 (0.0 to 10.0)0 (0.0 to 9.3)
SecondaryMGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay

MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1.

Time frame:
At Day 29 and at Day 85, compared to Day 1
Reported as:
Geometric mean · Ratio
MGI for Anti-H1N1 Swine Influenza and Anti-IIV4-H1N1 Antibodies Titers Measured by MN Assay
RatioD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Day 291.4 (1.1 to 1.7)1.7 (1.3 to 2.1)1.4 (1.2 to 1.6)1.7 (1.3 to 2.2)1.7 (1.4 to 2.2)1.4 (1.2 to 1.7)1.3 (1.0 to 1.5)1.1 (0.9 to 1.3)1.2 (1.0 to 1.5)1.7 (1.4 to 2.0)
Day 851.1 (0.9 to 1.3)1.5 (1.1 to 2.0)1.6 (1.2 to 2.1)1 (0.9 to 1.3)1.5 (1.2 to 1.9)1.5 (1.2 to 1.9)1.1 (0.9 to 1.3)0.9 (0.8 to 1.1)1.3 (1.1 to 1.6)1.5 (1.3 to 1.9)

Adverse events

Collected over Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 28-day follow-up period after any vaccination. SAEs were collected during the entire study period (from Day 1 up to Month 26).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
D-SUIV Adjuvanted Group 10/45 (0%)2/45 (4.4%)40/45 (88.9%)
D-SUIV Adjuvanted Group 20/46 (0%)1/46 (2.2%)43/46 (93.5%)
D-SUIV Adjuvanted Group 30/47 (0%)1/47 (2.1%)44/47 (93.6%)
D-SUIV Adjuvanted Group 40/47 (0%)2/47 (4.3%)44/47 (93.6%)
D-SUIV Adjuvanted Group 50/48 (0%)2/48 (4.2%)45/48 (93.8%)
D-SUIV Adjuvanted Group 61/47 (2.1%)2/47 (4.3%)44/47 (93.6%)
D-SUIV Unadjuvanted Group 10/47 (0%)0/47 (0%)34/47 (72.3%)
D-SUIV Unadjuvanted Group 20/48 (0%)2/48 (4.2%)38/48 (79.2%)
D-SUIV Unadjuvanted Group 30/46 (0%)2/46 (4.3%)42/46 (91.3%)
IIV4 Group0/47 (0%)3/47 (6.4%)44/47 (93.6%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Drug hypersensitivityImmune system disorders1/450/460/470/470/480/470/470/480/460/47
Wound infectionInfections and infestations1/450/460/470/470/480/470/470/480/460/47
Ectopic pregnancyPregnancy, puerperium and perinatal conditions1/450/460/470/470/480/470/470/480/460/47
Meningitis viralInfections and infestations0/450/460/470/470/480/470/470/481/460/47
Malignant melanoma stage IINeoplasms benign, malignant and unspecified (incl cysts and polyps)0/450/460/470/470/480/470/470/481/460/47
MenometrorrhagiaReproductive system and breast disorders0/451/460/470/470/480/470/470/480/460/47
Ankyloglossia congenitalCongenital, familial and genetic disorders0/450/460/470/470/480/470/470/480/461/47
CholecystitisHepatobiliary disorders0/450/460/470/470/480/470/470/480/461/47
CholelithiasisHepatobiliary disorders0/450/460/470/470/480/470/470/480/461/47
InfluenzaInfections and infestations0/450/460/471/470/480/470/470/480/460/47
Most frequent other events
Showing 10 of 158
Most frequent other events
EventD-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 Group
Injection site painGeneral disorders37/4542/4641/4743/4742/4844/4718/4722/4823/4639/47
HeadacheNervous system disorders25/4529/4630/4731/4725/4834/4720/4725/4820/4623/47
MyalgiaMusculoskeletal and connective tissue disorders24/4523/4630/4727/4726/4828/4710/4714/4815/4612/47
FatigueGeneral disorders25/4528/4628/4725/4725/4826/4718/4724/4818/4615/47
ChillsGeneral disorders9/4516/4615/4713/4720/4817/473/474/485/463/47
Gastrointestinal disorderGastrointestinal disorders10/4515/4614/4711/4712/4815/478/4710/4812/469/47
ArthralgiaMusculoskeletal and connective tissue disorders12/4513/4613/476/4713/4813/477/476/485/465/47
PyrexiaGeneral disorders7/4511/468/479/476/489/475/474/486/466/47
Upper respiratory tract infectionInfections and infestations2/457/465/474/473/484/475/479/487/464/47
Oropharyngeal painRespiratory, thoracic and mediastinal disorders3/456/461/475/475/481/475/474/486/461/47

Baseline characteristics

Age, Continuous
Age, Continuous(Years)D-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 GroupTotal
Mean29.0 ± 6.629.3 ± 5.728.6 ± 6.028.7 ± 6.429.1 ± 6.228.8 ± 6.129.6 ± 5.828.5 ± 5.928.8 ± 5.929.3 ± 5.829.0 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)D-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 GroupTotal
Female26272828272727262527268
Male19191919212020222120200
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)D-SUIV Adjuvanted Group 1D-SUIV Adjuvanted Group 2D-SUIV Adjuvanted Group 3D-SUIV Adjuvanted Group 4D-SUIV Adjuvanted Group 5D-SUIV Adjuvanted Group 6D-SUIV Unadjuvanted Group 1D-SUIV Unadjuvanted Group 2D-SUIV Unadjuvanted Group 3IIV4 GroupTotal
American indian or alaska native00001000001
Asian - central / south asian heritage00000000101
Asian - east asian heritage01000000001
Asian - south east asian heritage01010000002
Black or african american1191085710136988
Native hawaiian or other pacific islander00000010001
Other, Not specified000221112110
White - arabic / north african heritage01000101025
White - caucasian / european heritage34343736403835333735359
08

Study locations

6 sites
  • GSK Investigational Site
    South Miami, Florida 33143, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Rochester, New York 14609, United States
  • GSK Investigational Site
    Austin, Texas 78705, United States
  • GSK Investigational Site
    Norfolk, Virginia 23502, United States
  • GSK Investigational Site
    Wilrijk, 2610, Belgium
09

References and documents

Publications

  • Folschweiller N, Vanden Abeele C, Chu L, Van Damme P, Garcia-Sastre A, Krammer F, Nachbagauer R, Palese P, Solorzano A, Bi D, David MP, Friel D, Innis BL, Koch J, Mallett CP, Rouxel RN, Salaun B, Vantomme V, Verheust C, Struyf F. Reactogenicity, safety, and immunogenicity of chimeric haemagglutinin influenza split-virion vaccines, adjuvanted with AS01 or AS03 or non-adjuvanted: a phase 1-2 randomised controlled trial. Lancet Infect Dis. 2022 Jul;22(7):1062-1075. doi: 10.1016/S1473-3099(22)00024-X. Epub 2022 Apr 21. Erratum In: Lancet Infect Dis. 2022 Jun;22(6):e159. doi: 10.1016/S1473-3099(22)00281-X. PubMed 35461522 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Mar 2020, 30 months.

Results were first posted in May 2021, 1 year 1 month after primary completion.

Of 94 industry-sponsored phase 1 interventional studies under Influenza, Human, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 30 months is above that.

Counting every sponsor, half of 148 studies reached it within 11 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 7, 2017
StartActual
Sep 8, 2017
Primary completionActual
Mar 26, 2020
CompletionActual
Mar 26, 2020
Results first posted
May 7, 2021
Last update
May 7, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03275389
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Sep 8, 2017
Primary completion
Mar 26, 2020
Completion
Mar 26, 2020
Results posted
May 7, 2021
Last update
May 7, 2021

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
Yes
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 Apr 2021. You cannot join it, but the record below documents what was studied.

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