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CompletedNCT06560151Updated Oct 1, 2026Results posted

Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59

A Phase 2 interventional study of 3.75 µg H5N8 antigen plus full dose AS03A and 7.5 µg H5N8 antigen plus full dose AS03A in Influenza, sponsored by Biomedical Advanced Research and Development Authority. Completed at 20 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Biomedical Advanced Research and Development Authority · Phase 2, Interventional, and Other

Updated Oct 1, 2026Posted results revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
1,380
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.

Read the detailed description

This is a randomized, double-blind, phase 2 study to assess safety and immunogenicity of egg-based H5N8 and H5N1 influenza vaccines at different antigen dose levels (3.75, 7.5, and 15 μg) adjuvanted with AS03A full dose, AS03A half dose (H5N8 only), or MF59. AS03A is the adjuvant AS03®. Healthy adult male and female (non-pregnant) participants, aged 18 years and older, will be screened for baseline health status to ensure trial eligibility. Participants meeting all the inclusion and none of the exclusion criteria will be randomized to receive vaccine doses according to treatment groups defined by antigen (H5N1 or H5N8), antigen dose level (3.75, 7.5, and 15 μg), and adjuvant (AS03A full dose, AS03A half dose, or MF59). Two doses of adjuvanted vaccine separated by 21 days will be administered to approximately 1380 participants, including 780 participants 18 through 64 years old who will be randomized equally to 1 of 13 treatment groups (A, B, C, D, E, F, G, H, I, J, K, M, and N), and 600 participants ≥65 years old who will be randomized equally to 1 of 10 treatment groups (B, C, E, F, H, I, K, L, N, and O).

Safety assessments will be based on solicited Adverse Events (AEs) (local and systemic reactogenicity symptoms) with onset within 8 days following each vaccination, inclusive of the vaccination day (Day 1 through Day 8 and Day 22 through Day 29); unsolicited Treatment Emergent Adverse Events (TEAEs) with onset within 22 days following each vaccination, inclusive of the vaccination day (Day 1 through Day 22 and Day 22 through Day 43); and treatment-emergent Serious Adverse Events (SAEs), Potential Immune-Mediated Diseases (pIMDs), and Medically Attended Adverse Events (MAAEs) occurring during study participation (through Day 203). Immunogenicity assessments will include titer, seroprotection rate, and seroconversion rate based on serum Hemagglutination Inhibition (HAI) antibodies, and titer and seroconversion rate based on serum microneutralization (MN) antibodies. Study vaccines will be prepared and administered by unblinded personnel. All other trial assessments will be performed only by blinded personnel.

02

Conditions studied

  • Influenza

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Keywords

  • A/H5
  • H5
  • Inactivated
  • Monovalent
  • Influenza
  • Vaccines
  • AS03
  • MF59
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's enrollment of 1,380 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Biomedical Advanced Research and Development Authority is the lead sponsor of 10 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
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

  1. Male or non-pregnant female, 18 years of age or older at the time of screening and .
  2. Willing and able to provide written informed consent prior to initiation of study procedures.
  3. Agrees to have specimens collected during this trial specifically for the purpose of future research stored for future research use.

  4. In relatively stable health, as determined by medical history and physical examination.

    a. Any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during the study period, and in the opinion of the site investigator, will not impact the ability to assess safety and/or immunogenicity per the study design.

  5. If a female of who is sexually active, agrees to use an adequate method of from Screening through 4 weeks following the last study vaccination and has used an adequate birth control method for at least 2 months prior to Screening.

    a. Female of childbearing potential is defined as post onset menarche and pre-menopausal person capable of becoming pregnant. This does not include females who meet any of the following conditions:

    i. menopausal >2 years

    ii. tubal ligation >1 year

    iii. bilateral salpingo-oophorectomy

    iv. hysterectomy.

    b. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; the female participant has exclusively female sexual partners; male partner is sterile or otherwise unable to produce sperm (information on the person's sterility can come from the site personnel's review of the participant's medical records or interview with the participant regarding her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); or male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).

  6. Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Has an acute illness, as determined by the site investigator, within 72 hours prior to vaccination.

    a. An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.

  2. Has a history of severe reaction to any influenza vaccine.
  3. Has a known allergy to squalene-based adjuvants.
  4. Female of who has a positive urine pregnancy test or who is currently breastfeeding.
  5. Has a >35 kg/m2 .
  6. Has known , , or infection (based on medical history).
  7. Has a history of any pIMDs (list provided in Protocol Appendix 3), neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to Screening, or a family history of Guillain-Barré syndrome.
  8. Has narcolepsy or a first degree relative with narcolepsy.
  9. Has a history of alcohol or drug abuse within 5 years prior to Screening.
  10. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any other psychiatric diagnosis that may, in the opinion of the site investigator, interfere with participant compliance or safety evaluations.
  11. Is due to an underlying disease or medication, use of anticancer chemotherapy (cytotoxic), or radiation therapy.
  12. With the exception of basal or squamous cell skin cancer, has known active neoplastic disease, including hematologic .
  13. Has long-term use (≥14 consecutive days) of including oral or parenteral prednisone or prednisone equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to screening in this study. However, participants on low-dose inhaled steroids (≤800 µg/day of beclomethasone dipropionate or equivalent) or topical steroids are not excluded.
  14. Has received immunoglobulin or other blood product (with the exception of Rho[D] immune globulin) within the 90 days prior to screening in this study.
  15. Has received any (licensed or under Emergency Use Authorization [EUA]) within 4 weeks or inactivated, messenger RNA (mRNA), or recombinant protein vaccines within 2 weeks prior to screening, or plans to receive such vaccines (including seasonal influenza and COVID-19 vaccines) from screening through 22 days following the second dose of the study vaccine, inclusive of the vaccination day (Screening Visit through Day 43).
  16. Is participating or plans to participate in another interventional clinical trial (either active or follow-up phase) during the study period.
  17. Has participated in an A(H5) influenza vaccine study in the past or has a history of A(H5) influenza infection prior to vaccination in this study. This includes, but is not limited to, influenza sub-types A(H5N1), A(H5N8), and A(H5N6).

  18. Has any laboratory test result or clinical findings (including vital signs) that singly or in combination are likely to unfavorably alter the risks of participant participation or to confound study safety or immunogenicity results, in the opinion of the site investigator. Additionally, the following are exclusionary:

    1. (ALT) or aspartate aminotransferase (AST) >2 times the (ULN), or
    2. >1.5 times the ULN unless isolated Gilbert's syndrome.
  19. Has any disease or medical condition that, in the opinion of the site investigator, might confound interpretation of safety or immunogenicity.
Terms in these criteria, in plain language(14)

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.

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,380 participants (actual)

Study arms

  • Experimental
    Treatment Group A

    This treatment group of 60 participants (ages 18-64) in Treatment Group A will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) antigen adjuvanted with a full dose of AS03A.

    Biological: 3.75 µg H5N8 antigen plus full dose AS03A

  • Experimental
    Treatment Group B

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants ages ≥65) in Treatment Group B will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.

    Biological: 7.5 µg H5N8 antigen plus full dose AS03A

  • Experimental
    Treatment Group C

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a full dose of AS03A.

    Biological: 15 µg H5N8 antigen plus full dose AS03A

  • Experimental
    Treatment Group D

    This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

    Biological: 3.75 µg H5N8 antigen plus half dose AS03A

  • Experimental
    Treatment Group E

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

    Biological: 7.5 µg H5N8 antigen plus half dose AS03A

  • Experimental
    Treatment Group F

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65 will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with a half dose of AS03A.

    Biological: 15 µg H5N8 antigen plus half dose AS03A

  • Experimental
    Treatment Group G

    This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

    Biological: 3.75 µg H5N8 antigen plus MF59

  • Experimental
    Treatment Group H

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

    Biological: 7.5 µg H5N8 antigen plus MF59

  • Experimental
    Treatment Group I

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 15 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.

    Biological: 15 µg H5N8 antigen plus MF59

  • Experimental
    Treatment Group J

    This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

    Biological: 3.75 µg H5N1 antigen plus full dose AS03A

  • Experimental
    Treatment Group K

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

    Biological: 7.5 µg H5N1 antigen plus full dose AS03A

  • Experimental
    Treatment Group L

    This treatment group of 60 participants (ages ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with a full dose of AS03A.

    Biological: 15 µg H5N1 antigen plus full dose AS03A

  • Experimental
    Treatment Group M

    This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

    Biological: 3.75 µg H5N1 antigen plus MF59

  • Experimental
    Treatment Group N

    This treatment group of 120 participants (60 participants ages 18-64 and 60 participants age ≥65) will receive 7.5 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

    Biological: 7.5 µg H5N1 antigen plus MF59

  • Experimental
    Treatment Group O

    This treatment group of 60 participants (age ≥65) will receive 15 µg of Egg-A/bar-headed goose/Qinghai Lake/1A/2005 (H5N1) adjuvanted with MF59.

    Biological: 15 µg H5N1 antigen plus MF59

Interventions

  • Biological3.75 µg H5N8 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological7.5 µg H5N8 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological15 µg H5N8 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological3.75 µg H5N8 antigen plus half dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological7.5 µg H5N8 antigen plus half dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological15 µg H5N8 antigen plus half dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.

  • Biological3.75 µg H5N8 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

  • Biological7.5 µg H5N8 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

  • Biological15 µg H5N8 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.

  • Biological3.75 µg H5N1 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

  • Biological7.5 µg H5N1 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

  • Biological15 µg H5N1 antigen plus full dose AS03A

    Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.

  • Biological3.75 µg H5N1 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

  • Biological7.5 µg H5N1 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

  • Biological15 µg H5N1 antigen plus MF59

    Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

06

What researchers measure

Primary outcomes

  1. The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.

    The percentage of participants who experienced at least one solicited local reactogenicity adverse event at the injection site during at least one of the time frames specified. Possible reactions included erythema/redness, induration (underlying hardening of tissue associated with inflammation)/swelling (localized tissue distention), and pain.

    Time frame: Day 1 through Day 8 and Day 22 through Day 29

  2. The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.

    The percentage of participants who experienced at least one solicited systemic reactogenicity adverse event during at least one of the time frames specified. Possible reactions included fever, myalgia, arthralgia, fatigue, headache, nausea, vomiting, diarrhea, and chills.

    Time frame: Day 1 through Day 8 and Day 22 through Day 29

  3. The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 43

Secondary outcomes

  1. The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.

    The percentage of participants who experienced at least one unsolicited TEAE during at least one of the time frames specified. Unsolicited TEAEs were defined as any adverse event other than those included in the lists for solicited local and systemic reactions.

    Time frame: Day 1 through Day 22 and Day 22 through Day 43

  2. The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).

    The percentage of participants who experienced at least one treatment-emergent SAE during the time frame specified.

    Time frame: Day 1 through Day 203

  3. The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).

    The percentage of participants who experienced at least one treatment-emergent MAAE during the time frame specified. MAAEs were defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

    Time frame: Day 1 through Day 203

  4. The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).

    The percentage of participants who experienced at least one treatment-emergent pIMD during the time frame specified. A comprehensive list of adverse events to be reported as pIMDs is available in Appendix 3 of the Protocol.

    Time frame: Day 1 through Day 203

  5. The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 43

  6. Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.

    Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Screening (i.e., pre-vaccination)

  7. Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.

    Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 22

  8. Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.

    Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 43

  9. Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.

    Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 203

  10. Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.

    Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Screening (i.e., pre-vaccination)

  11. Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.

    Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 22

  12. Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.

    Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 43

  13. Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203

    Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

    Time frame: Day 203

  14. The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 22

  15. The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 203

  16. The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 22

  17. The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

    Time frame: Day 203

  18. The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 22

  19. The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 43

  20. The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 203

  21. The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 22

  22. The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 43

  23. The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 203

  24. Serum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.

    Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Screening (i.e., pre-vaccination)

  25. Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.

    Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 22

  26. Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.

    Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 43

  27. Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.

    Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 203

  28. Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.

    Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Screening (i.e., pre-vaccination)

  29. Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.

    Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 22

  30. Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.

    Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 43

  31. Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.

    Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

    Time frame: Day 203

  32. The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 22

  33. The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 43

  34. The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 203

  35. The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 22

  36. The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 43

  37. The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

    The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

    Time frame: Day 203

07

Results

Posted Jul 23, 2026

Participant flow

Twenty clinical sites in the United States screened and enrolled participants into the trial.

Participant flow — Overall Study
Milestone3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
Started61121121601191206012011960118596012161
Completed55110108531101105511210955112585511358
Not completed6111379105810561583
Withdrew: Lost to follow-up3710566255331472
Withdrew: Withdrawal by subject233034335130101
Withdrew: Non-compliance with study schedule110200000100000
Withdrew: Subject incarcerated000000000000010

Outcome measures

PrimaryThe Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.

The percentage of participants who experienced at least one solicited local reactogenicity adverse event at the injection site during at least one of the time frames specified. Possible reactions included erythema/redness, induration (underlying hardening of tissue associated with inflammation)/swelling (localized tissue distention), and pain.

Time frame:
Day 1 through Day 8 and Day 22 through Day 29
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years62.3 (49.0 to 74.4)59.0 (45.7 to 71.4)67.2 (54.0 to 78.7)43.3 (30.6 to 56.8)60.0 (46.5 to 72.4)60.0 (46.5 to 72.4)48.3 (35.2 to 61.6)38.3 (26.1 to 51.8)28.8 (17.8 to 42.1)61.7 (48.2 to 73.9)72.4 (59.1 to 83.3)—33.3 (21.7 to 46.7)35.0 (23.1 to 48.4)—
>65 years—38.3 (26.1 to 51.8)30.0 (18.8 to 43.2)—45.8 (32.7 to 59.2)41.7 (29.1 to 55.1)—20.0 (10.8 to 32.3)23.3 (13.4 to 36.0)—46.7 (33.7 to 60.0)47.5 (34.3 to 60.9)—18.0 (9.4 to 30.0)36.1 (24.2 to 49.4)
Overall62.3 (49.0 to 74.4)48.8 (39.6 to 58.0)48.8 (39.6 to 58.0)43.3 (30.6 to 56.8)52.9 (43.6 to 62.2)50.8 (41.6 to 60.1)48.3 (35.2 to 61.6)29.2 (21.2 to 38.2)26.1 (18.4 to 34.9)61.7 (48.2 to 73.9)59.3 (49.9 to 68.3)47.5 (34.3 to 60.9)33.3 (21.7 to 46.7)26.4 (18.8 to 35.2)36.1 (24.2 to 49.4)
PrimaryThe Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.

The percentage of participants who experienced at least one solicited systemic reactogenicity adverse event during at least one of the time frames specified. Possible reactions included fever, myalgia, arthralgia, fatigue, headache, nausea, vomiting, diarrhea, and chills.

Time frame:
Day 1 through Day 8 and Day 22 through Day 29
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years50.8 (37.7 to 63.9)52.5 (39.3 to 65.4)55.7 (42.4 to 68.5)35.0 (23.1 to 48.4)38.3 (26.1 to 51.8)48.3 (35.2 to 61.6)48.3 (35.2 to 61.6)41.7 (29.1 to 55.1)18.6 (9.7 to 30.9)48.3 (35.2 to 61.6)51.7 (38.2 to 65.0)—30.0 (18.8 to 43.2)38.3 (26.1 to 51.8)—
>65 years—41.7 (29.1 to 55.1)28.3 (17.5 to 41.4)—35.6 (23.6 to 49.1)38.3 (26.1 to 51.8)—23.3 (13.4 to 36.0)23.3 (13.4 to 36.0)—33.3 (21.7 to 46.7)32.2 (20.6 to 45.6)—21.3 (11.9 to 33.7)18.0 (9.4 to 30.0)
Overall50.8 (37.7 to 63.9)47.1 (38.0 to 56.4)42.1 (33.2 to 51.5)35.0 (23.1 to 48.4)37.0 (28.3 to 46.3)43.3 (34.3 to 52.7)48.3 (35.2 to 61.6)32.5 (24.2 to 41.7)21.0 (14.1 to 29.4)48.3 (35.2 to 61.6)42.4 (33.3 to 51.8)32.2 (20.6 to 45.6)30.0 (18.8 to 43.2)29.8 (21.8 to 38.7)18.0 (9.4 to 30.0)
PrimaryThe Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years87.5 (75.9 to 94.8)89.8 (77.8 to 96.6)96.0 (86.3 to 99.5)87.3 (75.5 to 94.7)81.1 (68.0 to 90.6)81.1 (68.0 to 90.6)57.1 (43.2 to 70.3)75.4 (62.2 to 85.9)66.7 (52.1 to 79.2)8.0 (2.2 to 19.2)1.9 (0.0 to 10.3)—2.0 (0.1 to 10.9)7.3 (2.0 to 17.6)—
> 65 years—86.8 (74.7 to 94.5)80.4 (67.6 to 89.8)—78.0 (65.3 to 87.7)78.6 (65.6 to 88.4)—52.8 (38.6 to 66.7)63.2 (49.3 to 75.6)—11.9 (4.9 to 22.9)20.0 (10.4 to 33.0)—6.8 (1.9 to 16.5)3.4 (0.4 to 11.7)
SecondaryThe Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.

The percentage of participants who experienced at least one unsolicited TEAE during at least one of the time frames specified. Unsolicited TEAEs were defined as any adverse event other than those included in the lists for solicited local and systemic reactions.

Time frame:
Day 1 through Day 22 and Day 22 through Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years27.9 (17.1 to 40.8)23.0 (13.2 to 35.5)21.3 (11.9 to 33.7)28.3 (17.5 to 41.4)28.3 (17.5 to 41.4)18.3 (9.5 to 30.4)40.0 (27.6 to 53.5)25.0 (14.7 to 37.9)18.6 (9.7 to 30.9)20.0 (10.8 to 32.3)17.2 (8.6 to 29.4)—21.7 (12.1 to 34.2)16.7 (8.3 to 28.5)—
>65 years—28.3 (17.5 to 41.4)30.0 (18.8 to 43.2)—30.5 (19.2 to 43.9)25.0 (14.7 to 37.9)—31.7 (20.3 to 45.0)18.3 (9.5 to 30.4)—30.0 (18.8 to 43.2)27.1 (16.4 to 40.3)—36.1 (24.2 to 49.4)24.6 (14.5 to 37.3)
Overall27.9 (17.1 to 40.8)25.6 (18.1 to 34.4)25.6 (18.1 to 34.4)28.3 (17.5 to 41.4)29.4 (21.4 to 38.5)21.7 (14.7 to 30.1)40.0 (27.6 to 53.5)28.3 (20.5 to 37.3)18.5 (12.0 to 26.6)20.0 (10.8 to 32.3)23.7 (16.4 to 32.4)27.1 (16.4 to 40.3)21.7 (12.1 to 34.2)26.4 (18.8 to 35.2)24.6 (14.5 to 37.3)
SecondaryThe Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).

The percentage of participants who experienced at least one treatment-emergent SAE during the time frame specified.

Time frame:
Day 1 through Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (0.0 to 6.0)1.7 (0.0 to 8.9)0 (0.0 to 6.0)1.7 (0.0 to 8.9)3.3 (0.4 to 11.5)0 (0.0 to 6.1)0 (NA to NA)0 (NA to NA)—0 (0.0 to 6.0)3.3 (0.4 to 11.5)—
>65 years—1.7 (0.0 to 8.9)1.7 (0.0 to 8.9)—1.7 (0.0 to 9.1)1.7 (0.0 to 8.9)—8.3 (2.8 to 18.4)1.7 (0.0 to 8.9)—1.7 (0.0 to 8.9)1.7 (0.0 to 9.1)—0 (NA to NA)0 (NA to NA)
Overall0 (0.0 to 5.9)0.8 (0.0 to 4.5)0.8 (0.0 to 4.5)0 (0.0 to 6.0)1.7 (0.2 to 5.9)0.8 (0.0 to 4.6)1.7 (0.0 to 8.9)5.8 (2.4 to 11.6)0.8 (0.0 to 4.6)0 (0.0 to 6.0)0.8 (0.0 to 4.6)1.7 (0.0 to 9.1)0 (0.0 to 6.0)1.7 (0.2 to 5.8)0 (0.0 to 5.9)
SecondaryThe Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).

The percentage of participants who experienced at least one treatment-emergent MAAE during the time frame specified. MAAEs were defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.

Time frame:
Day 1 through Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years8.2 (2.7 to 18.1)3.3 (0.4 to 11.3)6.6 (1.8 to 15.9)11.7 (4.8 to 22.6)3.3 (0.4 to 11.5)6.7 (1.8 to 16.2)16.7 (8.3 to 28.5)11.7 (4.8 to 22.6)5.1 (1.1 to 14.1)1.7 (0.0 to 8.9)10.3 (3.9 to 21.2)—5.0 (1.0 to 13.9)5.0 (1.0 to 13.9)—
>65 years—6.7 (1.8 to 16.2)15.0 (7.1 to 26.6)—8.5 (2.8 to 18.7)13.3 (5.9 to 24.6)—23.3 (13.4 to 36.0)5.0 (1.0 to 13.9)—8.3 (2.8 to 18.4)11.9 (4.9 to 22.9)—13.1 (5.8 to 24.2)3.3 (0.4 to 11.3)
Overall8.2 (2.7 to 18.1)5.0 (1.8 to 10.5)10.7 (5.8 to 17.7)11.7 (4.8 to 22.6)5.9 (2.4 to 11.7)10.0 (5.3 to 16.8)16.7 (8.3 to 28.5)17.5 (11.2 to 25.5)5.0 (1.9 to 10.7)1.7 (0.0 to 8.9)9.3 (4.7 to 16.1)11.9 (4.9 to 22.9)5.0 (1.0 to 13.9)9.1 (4.6 to 15.7)3.3 (0.4 to 11.3)
SecondaryThe Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).

The percentage of participants who experienced at least one treatment-emergent pIMD during the time frame specified. A comprehensive list of adverse events to be reported as pIMDs is available in Appendix 3 of the Protocol.

Time frame:
Day 1 through Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)—0 (NA to NA)0 (NA to NA)—
>65 Years—0 (NA to NA)0 (NA to NA)—0 (NA to NA)0 (NA to NA)—0 (NA to NA)0 (NA to NA)—0 (NA to NA)0 (NA to NA)—0 (NA to NA)0 (NA to NA)
Overall0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)0 (NA to NA)
SecondaryThe Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years8.9 (3.0 to 19.6)16.3 (7.3 to 29.7)8.0 (2.2 to 19.2)3.6 (0.4 to 12.5)5.7 (1.2 to 15.7)22.6 (12.3 to 36.2)8.9 (3.0 to 19.6)7.0 (1.9 to 17.0)5.9 (1.2 to 16.2)84.0 (70.9 to 92.8)86.5 (74.2 to 94.4)—59.2 (44.2 to 73.0)65.5 (51.4 to 77.8)—
>65 years—11.3 (4.3 to 23.0)12.5 (5.2 to 24.1)—18.6 (9.7 to 30.9)17.9 (8.9 to 30.4)—7.5 (2.1 to 18.2)8.8 (2.9 to 19.3)—83.1 (71.0 to 91.6)74.5 (61.0 to 85.3)—35.6 (23.6 to 49.1)47.5 (34.3 to 60.9)
SecondarySerum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.

Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Screening (i.e., pre-vaccination)
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years5.39 (4.64 to 6.25)5.48 (4.85 to 6.20)5.07 (4.93 to 5.21)5.00 (NA to NA)5.00 (NA to NA)5.97 (4.65 to 7.65)5.00 (NA to NA)5.00 (NA to NA)5.00 (NA to NA)5.00 (NA to NA)5.00 (NA to NA)—5.00 (NA to NA)5.50 (4.70 to 6.42)—
>65 years—5.37 (4.65 to 6.21)5.49 (4.75 to 6.34)—5.18 (4.92 to 5.46)5.59 (4.74 to 6.59)—5.10 (4.90 to 5.30)5.78 (4.92 to 6.80)—6.14 (4.96 to 7.60)5.71 (4.88 to 6.67)—6.00 (5.00 to 7.19)5.43 (5.02 to 5.87)
SecondarySerum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.

Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 22
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years30.84 (21.18 to 44.90)58.60 (38.97 to 88.13)42.87 (27.67 to 66.41)40.50 (27.20 to 60.32)35.78 (24.86 to 51.50)37.22 (25.29 to 54.77)21.01 (14.28 to 30.91)25.29 (17.49 to 36.59)23.22 (15.55 to 34.66)5.68 (5.17 to 6.24)6.27 (5.06 to 7.77)—6.18 (5.06 to 7.56)6.30 (5.33 to 7.44)—
>65 years—56.20 (37.30 to 84.67)49.66 (33.30 to 74.06)—43.68 (28.47 to 67.02)40.74 (27.89 to 59.52)—21.35 (14.65 to 31.11)26.45 (17.96 to 38.96)—8.09 (6.43 to 10.19)8.82 (6.79 to 11.44)—6.59 (5.56 to 7.81)8.00 (6.12 to 10.46)
SecondarySerum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.

Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 43
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years173.40 (118.24 to 254.30)200.63 (136.41 to 295.10)191.60 (147.68 to 248.59)132.44 (99.21 to 176.81)107.37 (72.05 to 160.01)91.77 (62.93 to 133.82)47.57 (31.41 to 72.04)76.65 (54.45 to 107.91)60.96 (40.53 to 91.69)7.17 (5.67 to 9.06)5.83 (4.98 to 6.82)—5.56 (4.74 to 6.53)7.21 (5.37 to 9.67)—
>65 years—132.35 (93.01 to 188.34)97.51 (66.17 to 143.70)—102.99 (71.24 to 148.88)93.39 (64.70 to 134.80)—36.26 (24.46 to 53.75)46.84 (33.20 to 66.09)—9.10 (6.63 to 12.49)10.99 (7.82 to 15.45)—7.86 (6.14 to 10.05)6.40 (5.33 to 7.68)
SecondarySerum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.

Serum HAI antibody titer levels against the H5N8 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 203
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years59.22 (42.35 to 82.79)70.25 (48.49 to 101.76)67.98 (47.34 to 97.62)47.23 (34.87 to 63.97)45.00 (31.51 to 64.26)48.86 (34.85 to 68.48)23.09 (16.87 to 31.60)31.67 (23.35 to 42.94)28.29 (20.87 to 38.34)5.74 (5.15 to 6.39)7.17 (5.85 to 8.79)—5.71 (5.03 to 6.48)5.65 (5.00 to 6.38)—
≥65 years—49.80 (34.99 to 70.89)62.27 (44.75 to 86.67)—47.14 (33.77 to 65.80)49.30 (35.78 to 67.91)—16.76 (11.90 to 23.60)28.46 (20.98 to 38.60)—9.00 (7.11 to 11.38)9.04 (7.39 to 11.05)—8.67 (6.96 to 10.80)9.00 (6.95 to 11.66)
SecondarySerum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.

Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Screening (i.e., pre-vaccination)
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years5.06 (4.94 to 5.19)5.64 (5.09 to 6.25)5.18 (4.93 to 5.44)5.13 (4.95 to 5.31)5.07 (4.93 to 5.20)5.56 (5.05 to 6.12)5.06 (4.94 to 5.19)5.06 (4.94 to 5.19)5.14 (4.86 to 5.43)5.14 (4.94 to 5.34)5.07 (4.93 to 5.21)—5.22 (4.97 to 5.47)5.13 (4.95 to 5.31)—
≥65 years—5.85 (5.27 to 6.49)6.17 (4.94 to 7.70)—5.79 (5.07 to 6.61)6.29 (5.30 to 7.46)—5.81 (4.92 to 6.87)5.79 (5.10 to 6.56)—7.54 (6.06 to 9.38)6.17 (5.15 to 7.39)—6.03 (5.14 to 7.08)6.25 (5.46 to 7.15)
SecondarySerum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.

Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 22
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years9.46 (7.54 to 11.87)9.93 (7.72 to 12.77)9.79 (7.51 to 12.77)8.87 (7.09 to 11.10)10.26 (8.19 to 12.87)16.11 (11.39 to 22.79)10.25 (7.60 to 13.82)9.05 (7.31 to 11.21)11.69 (8.98 to 15.21)20.43 (13.83 to 30.17)24.58 (16.90 to 35.75)—15.29 (10.97 to 21.30)16.18 (11.44 to 22.88)—
≥65 years—11.85 (9.20 to 15.26)10.12 (8.17 to 12.53)—13.02 (9.71 to 17.48)15.80 (11.58 to 21.56)—8.06 (6.22 to 10.44)10.06 (7.80 to 12.98)—32.95 (23.08 to 47.03)31.68 (21.09 to 47.58)—15.72 (11.22 to 22.02)20.83 (14.65 to 29.63)
SecondarySerum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.

Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 43
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years10.06 (7.94 to 12.75)12.72 (9.93 to 16.28)11.49 (8.56 to 15.41)7.97 (6.52 to 9.73)9.68 (7.45 to 12.56)14.70 (10.88 to 19.87)8.84 (6.60 to 11.83)8.33 (7.01 to 9.90)9.09 (7.03 to 11.75)122.95 (81.12 to 186.33)124.19 (90.40 to 170.60)—43.22 (28.80 to 64.88)51.13 (36.13 to 72.36)—
≥65 years—11.10 (8.71 to 14.14)11.04 (8.56 to 14.23)—13.33 (9.82 to 18.11)13.79 (10.26 to 18.54)—8.27 (6.36 to 10.76)8.59 (6.89 to 10.71)—101.78 (73.42 to 141.10)79.49 (54.35 to 116.26)—23.30 (16.34 to 33.22)27.62 (19.47 to 39.19)
SecondarySerum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203

Serum HAI antibody titer levels against the H5N1 antigen. A higher HAI titer means a better immune response against the antigen.

Time frame:
Day 203
Reported as:
Geometric mean · Titers
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years8.16 (6.73 to 9.89)7.88 (6.44 to 9.64)7.80 (6.44 to 9.45)6.20 (5.50 to 6.98)6.83 (5.94 to 7.85)8.35 (6.36 to 10.97)6.67 (5.59 to 7.95)6.00 (5.44 to 6.62)6.59 (5.42 to 8.00)30.61 (22.61 to 41.46)36.48 (27.76 to 47.95)—14.03 (10.75 to 18.32)13.85 (10.61 to 18.07)—
≥65 years—8.74 (6.81 to 11.22)8.74 (7.03 to 10.85)—9.43 (7.32 to 12.14)10.20 (7.64 to 13.60)—6.41 (5.41 to 7.59)7.25 (6.18 to 8.51)—39.76 (29.70 to 53.23)33.32 (24.43 to 45.43)—15.23 (11.38 to 20.38)12.73 (9.54 to 16.98)
SecondaryThe Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years42.9 (29.7 to 56.8)69.4 (54.6 to 81.7)54.0 (39.3 to 68.2)54.5 (40.6 to 68.0)52.8 (38.6 to 66.7)54.7 (40.4 to 68.4)28.6 (17.3 to 42.2)37.5 (24.9 to 51.5)35.3 (22.4 to 49.9)0.0 (NA to NA)3.8 (0.5 to 13.2)—6.1 (1.3 to 16.9)3.7 (0.5 to 12.7)—
≥65 years—60.4 (46.0 to 73.5)57.1 (43.2 to 70.3)—54.2 (40.8 to 67.3)53.6 (39.7 to 67.0)—37.7 (24.8 to 52.1)38.6 (26.0 to 52.4)—8.5 (2.8 to 18.7)12.7 (5.3 to 24.5)—1.7 (0.0 to 9.1)10.2 (3.8 to 20.8)
SecondaryThe Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N8 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years64.2 (49.8 to 76.9)70.8 (55.9 to 83.0)77.6 (63.4 to 88.2)60.0 (45.2 to 73.6)60.0 (45.2 to 73.6)55.8 (41.3 to 69.5)34.0 (21.5 to 48.3)43.6 (30.3 to 57.7)38.8 (25.5 to 53.8)0.0 (NA to NA)2.0 (0.1 to 10.9)—2.1 (0.1 to 11.3)2.0 (0.0 to 10.4)—
≥65 years—63.3 (48.3 to 76.6)61.1 (46.9 to 74.1)—59.3 (45.7 to 71.9)60.4 (46.0 to 73.5)—28.3 (16.8 to 42.3)38.2 (25.4 to 52.3)—8.5 (2.8 to 18.7)5.5 (1.1 to 15.1)—7.1 (2.0 to 17.3)14.3 (6.4 to 26.2)
SecondaryThe Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years10.7 (4.0 to 21.9)10.2 (3.4 to 22.2)10.0 (3.3 to 21.8)7.3 (2.0 to 17.6)9.4 (3.1 to 20.7)20.8 (10.8 to 34.1)12.5 (5.2 to 24.1)8.9 (3.0 to 19.6)17.6 (8.4 to 30.9)28.6 (16.6 to 43.3)36.5 (23.6 to 51.0)—22.4 (11.8 to 36.6)22.2 (12.0 to 35.6)—
≥65 years—15.1 (6.7 to 27.6)10.7 (4.0 to 21.9)—16.9 (8.4 to 29.0)19.6 (10.2 to 32.4)—7.5 (2.1 to 18.2)12.3 (5.1 to 23.7)—44.1 (31.2 to 57.6)47.3 (33.7 to 61.2)—23.7 (13.6 to 36.6)35.6 (23.6 to 49.1)
SecondaryThe Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroprotection, defined as serum HAI antibody titer ≥ 1:40 against the H5N1 antigen. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid infection in half of exposed individuals.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years3.8 (0.5 to 13.0)6.3 (1.3 to 17.2)2.0 (0.1 to 10.9)0.0 (NA to NA)0.0 (NA to NA)9.6 (3.2 to 21.0)3.8 (0.5 to 13.0)0.0 (NA to NA)2.0 (0.1 to 10.9)47.9 (33.3 to 62.8)57.1 (42.2 to 71.2)—19.1 (9.1 to 33.3)19.6 (9.8 to 33.1)—
≥65 years—12.2 (4.6 to 24.8)5.6 (1.2 to 15.4)—10.2 (3.8 to 20.8)9.4 (3.1 to 20.7)—3.8 (0.5 to 13.0)1.8 (0.0 to 9.7)—52.5 (39.1 to 65.7)52.7 (38.8 to 66.3)—19.6 (10.2 to 32.4)21.4 (11.6 to 34.4)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years41.1 (28.1 to 55.0)69.4 (54.6 to 81.7)54.0 (39.3 to 68.2)54.5 (40.6 to 68.0)52.8 (38.6 to 66.7)52.8 (38.6 to 66.7)28.6 (17.3 to 42.2)37.5 (24.9 to 51.5)35.3 (22.4 to 49.9)0.0 (NA to NA)3.8 (0.5 to 13.2)—6.1 (1.3 to 16.9)3.7 (0.5 to 12.7)—
≥65 years—58.5 (44.1 to 71.9)57.1 (43.2 to 70.3)—54.2 (40.8 to 67.3)53.6 (39.7 to 67.0)—37.7 (24.8 to 52.1)38.6 (26.0 to 52.4)—8.5 (2.8 to 18.7)10.9 (4.1 to 22.2)—0.0 (NA to NA)8.5 (2.8 to 18.7)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years85.7 (73.8 to 93.6)89.8 (77.8 to 96.6)96.0 (86.3 to 99.5)87.3 (75.5 to 94.7)81.1 (68.0 to 90.6)79.2 (65.9 to 89.2)57.1 (43.2 to 70.3)75.4 (62.2 to 85.9)66.7 (52.1 to 79.2)8.0 (2.2 to 19.2)1.9 (0.0 to 10.3)—2.0 (0.1 to 10.9)7.3 (2.0 to 17.6)—
≥65 years—86.8 (74.7 to 94.5)80.4 (67.6 to 89.8)—78.0 (65.3 to 87.7)76.8 (63.6 to 87.0)—52.8 (38.6 to 66.7)61.4 (47.6 to 74.0)—11.9 (4.9 to 22.9)18.2 (9.1 to 30.9)—5.1 (1.1 to 14.1)3.4 (0.4 to 11.7)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years62.3 (47.9 to 75.2)70.8 (55.9 to 83.0)77.6 (63.4 to 88.2)60.0 (45.2 to 73.6)60.0 (45.2 to 73.6)53.8 (39.5 to 67.8)34.0 (21.5 to 48.3)43.6 (30.3 to 57.7)38.8 (25.2 to 53.8)0 (NA to NA)2.0 (0.1 to 10.9)—2.1 (0.1 to 11.3)2.0 (0.0 to 10.4)—
≥65 years—61.2 (46.2 to 74.8)61.1 (46.9 to 74.1)—59.3 (45.7 to 71.9)60.4 (46.0 to 73.5)—26.4 (15.3 to 40.3)36.4 (23.8 to 50.4)—8.5 (2.8 to 18.7)5.5 (1.1 to 15.1)—3.6 (0.4 to 12.3)12.5 (5.2 to 24.1)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years10.7 (4.0 to 21.9)6.1 (1.3 to 16.9)10.0 (3.3 to 21.8)7.3 (2.0 to 17.6)9.4 (3.1 to 20.7)20.8 (10.8 to 34.1)12.5 (5.2 to 24.1)8.9 (3.0 to 19.6)17.6 (8.4 to 30.9)28.6 (16.6 to 43.3)36.5 (23.6 to 51.0)—22.4 (11.8 to 36.6)22.2 (12.0 to 35.6)—
≥65 years—13.2 (5.5 to 25.3)7.1 (2.0 to 17.3)—13.6 (6.0 to 25.0)16.1 (7.6 to 28.3)—5.7 (1.2 to 15.7)8.8 (2.9 to 19.3)—40.7 (28.1 to 54.3)45.5 (32.0 to 59.4)—22.0 (12.3 to 34.7)35.6 (23.6 to 49.1)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years8.9 (3.0 to 19.6)14.3 (5.9 to 27.2)8.0 (2.2 to 19.2)3.6 (0.4 to 12.5)5.7 (1.2 to 15.7)22.6 (12.3 to 36.2)8.9 (3.0 to 19.6)7.0 (1.9 to 17.0)5.9 (1.2 to 16.2)84.0 (70.9 to 92.8)84.6 (71.9 to 93.1)—59.2 (44.2 to 73.0)65.5 (51.4 to 77.8)—
≥65 years—9.4 (3.1 to 20.7)10.7 (4.0 to 21.9)—15.3 (7.2 to 27.0)14.3 (6.4 to 26.2)—5.7 (1.2 to 15.7)7.0 (1.9 to 17.0)—79.7 (67.2 to 89.0)70.9 (57.1 to 82.4)—33.9 (22.1 to 47.4)44.1 (31.2 to 57.6)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination HAI antibody titer \<1:10 and a post-vaccination HAI titer ≥ 1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years3.8 (0.5 to 13.0)2.1 (0.1 to 11.1)2.0 (0.1 to 10.9)0 (NA to NA)0 (NA to NA)7.7 (2.1 to 18.5)3.8 (0.5 to 13.0)0 (NA to NA)2.0 (0.1 to 10.9)47.9 (33.3 to 62.8)55.1 (40.2 to 69.3)—19.1 (9.1 to 33.3)19.6 (9.8 to 33.1)—
≥65 years—10.2 (3.4 to 22.2)3.7 (0.5 to 12.7)—8.5 (2.8 to 18.7)7.5 (2.1 to 18.2)—0 (NA to NA)1.8 (0.0 to 9.7)—45.8 (32.7 to 59.2)47.3 (33.7 to 61.2)—16.1 (7.6 to 28.3)17.9 (8.9 to 30.4)
SecondarySerum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.

Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Screening (i.e., pre-vaccination)
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years5.35 (4.67 to 6.13)5.22 (4.97 to 5.47)5.25 (4.87 to 5.65)5.00 (NA to NA)5.34 (4.68 to 6.09)5.55 (4.50 to 6.85)5.13 (4.88 to 5.39)5.06 (4.94 to 5.19)5.07 (4.93 to 5.21)5.00 (NA to NA)5.00 (NA to NA)—5.00 (NA to NA)5.00 (NA to NA)—
≥65 years—5.41 (4.81 to 6.08)5.49 (4.89 to 6.16)—5.00 (NA to NA)5.13 (4.95 to 5.31)—5.00 (NA to NA)5.28 (4.84 to 5.77)—5.37 (4.83 to 5.96)5.19 (4.81 to 5.60)—5.40 (4.93 to 5.91)5.86 (4.86 to 7.06)
SecondarySerum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.

Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 22
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years34.96 (22.40 to 54.55)41.77 (28.26 to 61.75)38.10 (24.59 to 59.03)27.58 (19.09 to 39.84)23.70 (16.19 to 34.69)21.40 (14.37 to 31.89)15.23 (10.23 to 22.69)21.28 (14.25 to 31.77)14.24 (9.61 to 21.09)5.14 (4.94 to 5.35)5.49 (4.55 to 6.62)—5.00 (NA to NA)5.00 (NA to NA)—
≥65 years—17.74 (13.22 to 23.80)29.71 (19.53 to 45.19)—18.42 (12.68 to 26.75)22.12 (14.52 to 33.69)—10.20 (7.30 to 14.25)12.89 (8.88 to 18.71)—5.62 (4.77 to 6.63)6.81 (5.24 to 8.85)—5.40 (4.63 to 6.29)5.93 (4.88 to 7.21)
SecondarySerum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.

Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 43
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years433.35 (330.18 to 568.78)492.63 (362.09 to 670.22)331.29 (250.70 to 437.79)269.09 (198.33 to 365.10)203.79 (136.32 to 304.65)198.53 (144.05 to 273.62)84.04 (54.11 to 130.52)129.33 (92.34 to 181.14)111.57 (74.17 to 167.83)6.07 (4.83 to 7.63)5.53 (4.64 to 6.59)—5.29 (4.72 to 5.93)5.46 (4.69 to 6.37)—
≥65 years—211.92 (147.29 to 304.93)148.53 (99.21 to 222.37)—179.95 (125.02 to 259.01)162.00 (118.10 to 222.22)—51.86 (33.39 to 80.55)60.84 (40.71 to 90.94)—6.55 (5.13 to 8.37)8.12 (5.75 to 11.47)—5.46 (4.72 to 6.31)6.07 (4.84 to 7.61)
SecondarySerum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.

Serum MN antibody titer levels against the H5N8 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 203
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years34.19 (25.08 to 46.60)41.47 (28.75 to 59.81)46.74 (33.23 to 65.75)27.13 (19.60 to 37.55)29.08 (19.77 to 42.77)30.23 (21.86 to 41.81)16.76 (12.13 to 23.15)21.18 (16.15 to 27.78)16.06 (11.67 to 22.09)5.07 (4.93 to 5.22)5.33 (4.81 to 5.91)—5.00 (NA to NA)5.21 (4.80 to 5.65)—
≥65 years—25.61 (19.42 to 33.76)31.81 (22.84 to 44.32)—29.47 (21.58 to 40.24)27.37 (19.16 to 39.10)—11.85 (8.60 to 16.34)13.79 (10.51 to 18.09)—5.76 (4.94 to 6.71)5.78 (4.98 to 6.70)—5.59 (4.69 to 6.67)5.76 (4.96 to 6.70)
SecondarySerum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.

Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Screening (i.e., pre-vaccination)
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years5.49 (5.01 to 6.01)6.14 (5.05 to 7.46)5.78 (5.08 to 6.58)5.29 (4.95 to 5.66)5.17 (4.93 to 5.41)5.74 (4.95 to 6.64)5.52 (4.95 to 6.15)5.06 (4.94 to 5.19)5.39 (4.92 to 5.90)5.36 (4.92 to 5.83)5.54 (5.09 to 6.02)—5.22 (4.97 to 5.47)5.64 (5.04 to 6.30)—
≥65 years—6.49 (5.37 to 7.85)7.25 (5.70 to 9.21)—6.14 (5.33 to 7.08)6.65 (5.58 to 7.91)—5.89 (5.08 to 6.82)6.21 (5.35 to 7.21)—7.29 (5.77 to 9.19)7.92 (6.13 to 10.23)—6.21 (4.99 to 7.74)6.71 (5.33 to 8.44)
SecondarySerum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.

Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 22
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years7.72 (5.89 to 10.14)8.23 (6.20 to 10.91)9.52 (6.96 to 13.04)7.30 (5.78 to 9.21)7.80 (6.45 to 9.43)11.22 (7.44 to 16.93)8.49 (5.85 to 12.31)7.44 (5.98 to 9.24)7.37 (5.40 to 10.05)19.44 (12.43 to 30.39)30.03 (18.79 to 47.98)—11.52 (8.50 to 15.61)14.23 (9.84 to 20.58)—
≥65 years—8.49 (6.67 to 10.81)10.25 (7.74 to 13.57)—11.86 (8.47 to 16.60)12.73 (9.09 to 17.83)—7.45 (5.78 to 9.60)10.37 (7.43 to 14.48)—36.41 (22.17 to 59.77)41.54 (24.63 to 70.07)—13.18 (8.88 to 19.56)19.53 (12.76 to 29.89)
SecondarySerum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.

Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 43
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years16.70 (11.95 to 23.35)18.89 (13.53 to 26.39)13.95 (10.16 to 19.15)10.26 (8.05 to 13.06)11.78 (8.43 to 16.44)17.43 (11.40 to 26.65)12.04 (8.28 to 17.51)8.96 (7.27 to 11.04)8.55 (6.23 to 11.74)294.45 (196.45 to 441.33)311.57 (217.39 to 446.55)—77.21 (49.66 to 120.02)106.22 (72.43 to 155.80)—
≥65 years—14.80 (10.78 to 20.32)16.41 (11.99 to 22.45)—18.72 (12.86 to 27.25)24.99 (16.51 to 37.83)—10.67 (7.89 to 14.44)12.00 (8.54 to 16.87)—251.51 (168.45 to 375.53)219.26 (143.42 to 335.21)—44.54 (30.59 to 64.84)57.24 (37.21 to 88.04)
SecondarySerum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.

Serum MN antibody titer levels against the H5N1 antigen. A higher MN titer means a better immune response against the antigen.

Time frame:
Day 203
Reported as:
Geometric mean · Titers
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.
Titers3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years10.40 (8.05 to 13.42)14.24 (10.33 to 19.62)12.19 (9.20 to 16.15)7.74 (6.54 to 9.16)8.95 (7.46 to 10.73)12.21 (8.92 to 16.71)9.23 (6.84 to 12.46)7.58 (6.34 to 9.06)7.97 (6.22 to 10.21)61.24 (44.33 to 84.61)78.88 (54.54 to 114.10)—27.25 (19.72 to 37.66)30.89 (22.65 to 42.12)—
≥65 years—12.36 (9.46 to 16.14)12.76 (9.44 to 17.24)—11.31 (8.69 to 14.73)15.60 (11.05 to 22.03)—8.60 (6.80 to 10.88)9.81 (7.69 to 12.52)—70.30 (49.17 to 100.49)85.20 (60.31 to 120.36)—25.14 (18.45 to 34.25)25.45 (18.74 to 34.57)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years50.0 (36.1 to 63.9)56.3 (41.2 to 70.5)46.0 (31.8 to 60.7)45.5 (32.0 to 59.4)35.8 (23.1 to 50.2)27.5 (15.9 to 41.7)23.2 (13.0 to 36.4)30.4 (18.8 to 44.1)17.6 (8.4 to 30.9)0 (NA to NA)1.9 (0.0 to 10.3)—0 (NA to NA)0 (NA to NA)—
≥65 years—21.2 (11.1 to 34.7)42.9 (29.7 to 56.8)—27.1 (16.4 to 40.3)34.5 (22.2 to 48.6)—9.4 (3.1 to 20.7)19.6 (10.2 to 32.4)—1.7 (0.0 to 9.1)7.3 (2.0 to 17.6)—1.7 (0.0 to 9.1)1.7 (0.0 to 9.1)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years96.4 (87.7 to 99.6)95.9 (86.0 to 99.5)96.0 (86.3 to 99.5)94.4 (84.6 to 98.8)83.0 (70.2 to 91.9)92.5 (81.8 to 97.9)62.5 (48.5 to 75.1)84.2 (72.1 to 92.5)82.0 (68.6 to 91.4)6.0 (1.3 to 16.5)1.9 (0.0 to 10.3)—2.0 (0.1 to 10.9)1.8 (0.0 to 9.7)—
≥65 years—88.7 (77.0 to 95.7)80.4 (67.6 to 89.8)—86.4 (75.0 to 94.0)91.1 (80.4 to 97.0)—57.7 (43.2 to 71.3)61.4 (47.6 to 74.0)—3.4 (0.4 to 11.7)10.9 (4.1 to 22.2)—1.7 (0.0 to 9.1)1.7 (0.0 to 9.1)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N8 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years52.8 (38.6 to 66.7)54.2 (39.2 to 68.6)59.2 (44.2 to 73.0)38.0 (24.7 to 52.8)46.0 (31.8 to 60.7)42.3 (28.7 to 56.8)28.3 (16.8 to 42.3)33.3 (21.1 to 47.5)18.4 (8.8 to 32.0)0 (NA to NA)2.0 (0.1 to 10.9)—0 (NA to NA)2.0 (0.0 to 10.4)—
≥65 years—42.9 (28.8 to 57.8)49.1 (35.1 to 63.2)—42.4 (29.6 to 55.9)43.4 (29.8 to 57.7)—18.9 (9.4 to 32.0)20.0 (10.4 to 33.0)—1.7 (0.0 to 9.1)1.8 (0.0 to 9.7)—1.8 (0.0 to 9.6)0 (NA to NA)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 22
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years7.3 (2.0 to 17.6)6.3 (1.3 to 17.2)6.0 (1.3 to 16.5)5.5 (1.1 to 15.1)3.8 (0.5 to 13.0)13.7 (5.7 to 26.3)9.1 (3.0 to 20.0)3.6 (0.4 to 12.5)5.9 (1.2 to 16.2)30.6 (18.3 to 45.4)36.5 (23.6 to 51.0)—12.2 (4.6 to 24.8)18.9 (9.4 to 32.0)—
≥65 years—5.7 (1.3 to 15.7)7.1 (2.0 to 17.3)—15.3 (7.2 to 27.0)16.1 (7.6 to 28.3)—1.9 (0.0 to 10.1)7.0 (1.9 to 17.0)—39.0 (26.5 to 52.6)47.3 (33.7 to 61.2)—13.6 (6.0 to 25.0)27.6 (16.7 to 40.9)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 43
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years25.9 (15.0 to 39.7)14.3 (5.9 to 27.2)18.0 (8.6 to 31.4)9.3 (3.1 to 20.3)18.9 (9.4 to 32.0)20.8 (10.8 to 34.1)16.1 (7.6 to 28.3)8.8 (2.9 to 19.3)3.9 (0.5 to 13.5)94.0 (83.5 to 98.7)94.2 (84.1 to 98.8)—71.4 (56.7 to 83.4)74.5 (61.0 to 85.3)—
≥65 years—22.6 (12.3 to 36.2)12.5 (5.2 to 24.1)—24.1 (13.9 to 37.2)25.0 (14.4 to 38.4)—7.5 (2.1 to 18.2)14.0 (6.3 to 25.8)—89.8 (79.2 to 96.2)89.1 (77.8 to 95.9)—53.4 (39.9 to 66.7)61.0 (47.4 to 73.5)
SecondaryThe Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).

The percentage of participants achieving seroconversion, defined as either a pre-vaccination MN antibody titer \<1:10 and a post-vaccination MN titer ≥ 1:40, or a pre-vaccination MN titer ≥1:10 and a minimum 4-fold rise in post-vaccination MN titer against the H5N1 antigen. Seroconversion represents the minimum intended effect of vaccination.

Time frame:
Day 203
Reported as:
Number · Percentage of Participants
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Percentage of Participants3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
18-64 years11.3 (4.3 to 23.0)12.5 (4.7 to 25.2)10.2 (3.4 to 22.2)0 (NA to NA)2.0 (0.1 to 10.6)11.5 (4.4 to 23.4)9.6 (3.2 to 21.0)5.5 (1.1 to 15.1)2.0 (0.1 to 10.9)66.7 (51.6 to 79.6)77.6 (63.4 to 88.2)—48.9 (34.1 to 63.9)43.1 (29.3 to 57.8)—
≥65 years—6.1 (1.3 to 16.9)9.3 (3.1 to 20.3)—10.2 (3.8 to 20.8)17.0 (8.1 to 29.8)—3.8 (0.5 to 13.0)5.5 (1.1 to 15.1)—64.4 (50.9 to 76.4)76.4 (63.0 to 86.8)—32.1 (20.3 to 46.0)32.1 (20.3 to 46.0)

Adverse events

Collected over From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
3.75 µg H5N8 Plus AS03A Full Dose0/61 (0%)0/61 (0%)46/61 (75.4%)
7.5 µg H5N8 Plus AS03A Full Dose0/121 (0%)1/121 (0.8%)77/121 (63.6%)
15 µg H5N8 Plus AS03A Full Dose0/121 (0%)1/121 (0.8%)74/121 (61.2%)
3.75 µg H5N8 Plus AS03A Half Dose0/60 (0%)0/60 (0%)31/60 (51.7%)
7.5 µg H5N8 Plus AS03A Half Dose0/119 (0%)2/119 (1.7%)73/119 (61.3%)
15 µg H5N8 Plus AS03A Half Dose0/120 (0%)1/120 (0.8%)75/120 (62.5%)
3.75 µg H5N8 Plus MF590/60 (0%)1/60 (1.7%)38/60 (63.3%)
7.5 µg H5N8 Plus MF590/120 (0%)7/120 (5.8%)52/120 (43.3%)
15 µg H5N8 Plus MF590/119 (0%)1/119 (0.8%)43/119 (36.1%)
3.75 µg H5N1 Plus AS03A Full Dose0/60 (0%)0/60 (0%)45/60 (75%)
7.5 µg H5N1 Plus AS03A Full Dose0/118 (0%)1/118 (0.8%)79/118 (66.9%)
15 µg H5N1 Plus AS03A Full Dose0/59 (0%)1/59 (1.7%)35/59 (59.3%)
3.75 µg H5N1 Plus MF590/60 (0%)0/60 (0%)33/60 (55%)
7.5 µg H5N1 Plus MF590/121 (0%)2/121 (1.7%)53/121 (43.8%)
15 µg H5N1 Plus MF590/61 (0%)0/61 (0%)27/61 (44.3%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
Event3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
Intracranial massNervous system disorders0/610/1210/1210/600/1190/1200/600/1200/1190/600/1181/590/600/1210/61
Wound infectionInfections and infestations0/610/1210/1210/600/1190/1201/600/1200/1190/600/1180/590/600/1210/61
Ankle fractureInjury, poisoning and procedural complications0/610/1210/1210/600/1190/1200/602/1200/1190/600/1180/590/600/1210/61
Myocardial infarctionCardiac disorders0/610/1210/1210/600/1190/1200/600/1201/1190/601/1180/590/600/1210/61
HaematemesisGastrointestinal disorders0/610/1210/1210/601/1190/1200/600/1200/1190/600/1180/590/600/1210/61
Acute kidney injuryRenal and urinary disorders0/610/1210/1210/601/1190/1200/600/1200/1190/600/1180/590/600/1210/61
PneumoniaInfections and infestations0/610/1210/1210/600/1191/1200/600/1200/1190/600/1180/590/600/1210/61
Hip fractureInjury, poisoning and procedural complications0/610/1210/1210/600/1190/1200/601/1200/1190/600/1180/590/600/1210/61
Back painMusculoskeletal and connective tissue disorders0/610/1210/1210/600/1190/1200/601/1200/1190/600/1180/590/600/1210/61
Lung carcinoma cell type unspecified stage IVNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/610/1210/1210/600/1191/1200/600/1200/1190/600/1180/590/600/1210/61
Most frequent other events
Showing 10 of 14
Most frequent other events
Event3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59
Injection site painGeneral disorders and administration site conditions37/6157/12153/12123/6057/11952/12028/6033/12028/11936/6065/11825/5918/6028/12119/61
MyalgiaMusculoskeletal and connective tissue disorders20/6138/12133/1219/6023/11930/12015/6013/1208/11917/6030/1188/597/6013/1214/61
FatigueGeneral disorders and administration site conditions18/6132/12126/12116/6028/11924/12015/6022/12012/11917/6033/11810/5910/6021/1215/61
HeadacheNervous system disorders14/6132/12121/12114/6022/11927/12017/6019/1209/11913/6022/1187/5912/6015/1215/61
ArthralgiaMusculoskeletal and connective tissue disorders14/6114/12112/1214/6014/1196/1207/609/1201/1194/6012/1183/595/606/1212/61
Injection site indurationGeneral disorders and administration site conditions13/6119/12114/1214/6015/11911/1207/604/1205/11910/6021/1189/594/607/1213/61
ChillsGeneral disorders and administration site conditions10/6120/12115/1212/6010/1199/1201/608/1202/1195/609/1183/592/604/1213/61
NauseaGastrointestinal disorders9/6110/12110/1213/605/1198/1203/604/1202/1195/606/1182/594/605/1210/61
Injection site erythemaGeneral disorders and administration site conditions9/6111/12116/1215/6014/11912/1204/604/1203/1198/6016/1188/594/605/1214/61
DiarrhoeaGastrointestinal disorders6/6113/1218/1214/606/1199/1203/6012/1204/1195/609/1180/597/609/1213/61

Baseline characteristics

The safety population included all participants who were randomized and received at least one vaccination.

Age, Categorical
Age, Categorical(Participants)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
<=18 years0011000000001003
Between 18 and 65 years6161605960606060596058059600777
>=65 years0606005960060600605906161600
Age, Continuous
Age, Continuous(years)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
Mean47.0 ± 11.8158.7 ± 16.5957.4 ± 17.0247.5 ± 11.7659.0 ± 16.7957.8 ± 17.4142.6 ± 13.1360.5 ± 16.3459.6 ± 15.7443.0 ± 12.9559.2 ± 14.9271.4 ± 4.6246.1 ± 12.8058.9 ± 16.3471.2 ± 4.8057.0 ± 16.53
Sex: Female, Male
Sex: Female, Male(Participants)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
Female375862346862276263336133366733736
Male246359265158335856275726245428644
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
Hispanic or Latino8108991011159460684117
Not Hispanic or Latino521091115110710747102106551105953112551236
Unknown or Not Reported12203323412011227
Race (NIH/OMB)
Race (NIH/OMB)(Participants)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
American Indian or Alaska Native0010131010000007
Asian23002534234022032
Native Hawaiian or Other Pacific Islander0100100000000002
Black or African American1225241218181123211713613189240
White43889344949244919437985344100521067
More than one race14132112123001022
Unknown or Not Reported30211100010010010
Region of Enrollment
Region of Enrollment(participants)3.75 µg H5N8 Plus AS03A Full Dose7.5 µg H5N8 Plus AS03A Full Dose15 µg H5N8 Plus AS03A Full Dose3.75 µg H5N8 Plus AS03A Half Dose7.5 µg H5N8 Plus AS03A Half Dose15 µg H5N8 Plus AS03A Half Dose3.75 µg H5N8 Plus MF597.5 µg H5N8 Plus MF5915 µg H5N8 Plus MF593.75 µg H5N1 Plus AS03A Full Dose7.5 µg H5N1 Plus AS03A Full Dose15 µg H5N1 Plus AS03A Full Dose3.75 µg H5N1 Plus MF597.5 µg H5N1 Plus MF5915 µg H5N1 Plus MF59Total
United States611211216011912060120119601185960121611380
08

Study locations

20 sites
  • DelRicht Research - Atlanta
    Atlanta, Georgia 30329, United States
  • Javara Research - Privia Medical Group Georgia
    Savannah, Georgia 31406, United States
  • Accellacare - Duly Health and Care - Oak Lawn
    Oak Lawn, Illinois 60453, United States
  • Johnson County Clin-Trials (JCCT)
    Lenexa, Kansas 66219, United States
  • Alliance for Multispecialty Research - Wichita East - Heartland Research Associates
    Wichita, Kansas 67207, United States
  • Alliance for Multispecialty Research - Lexington
    Lexington, Kentucky 40509, United States
  • DelRicht Research - New Orleans - Prytania Street
    New Orleans, Louisiana 70115, United States
  • DelRicht Research - Prairieville
    Prairieville, Louisiana 70769, United States
  • Rochester Clinical Research
    New York, New York 14609, United States
  • Accellacare - Cary
    Cary, North Carolina 27518, United States
  • Accellacare of Hickory
    Hickory, North Carolina 28601, United States
  • Accellacare - Piedmont Healthcare
    Statesville, North Carolina 28625, United States
  • Accellacare - Tradd Court
    Wilmington, North Carolina 28401, United States
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
  • DelRicht Research - Tulsa
    Tulsa, Oklahoma 74133, United States
  • Tekton Research - Oklahoma - Primary Health Partners
    Yukon, Oklahoma 73099, United States
  • Tekton Research - Austin
    Austin, Texas 78745, United States
  • Javara Research - Privia Medical Group Gulf Coast
    Conroe, Texas 77384, United States
  • Tekton Research - San Antonio
    San Antonio, Texas 78229, United States
  • DelRicht Research - Virgina
    Sterling, Virginia 20166, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

1 registry update 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 Aug 2024 to primary completion in Jan 2025, 4 months.

Results were first posted in Jul 2026, 1 year 6 months after primary completion. A results delay was requested in Nov 2025.

Of 36 non-industry phase 2 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 4 months is below that.

Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.

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

Registered
Aug 15, 2024
First posted
Aug 19, 2024
StartActual
Aug 21, 2024
Primary completionActual
Jan 16, 2025
CompletionActual
Jun 11, 2025
Results delay requested
Nov 20, 2025
Results first posted
Jul 23, 2026
Last update
Oct 1, 2026
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.
Results
Posted results revised
revised Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Posted results revised
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06560151
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborators
Rho Federal Systems Division, Inc., ICON plc
Responsible party
Sponsor
First posted
Aug 19, 2024
Start date
Aug 21, 2024
Primary completion
Jan 16, 2025
Completion
Jun 11, 2025
Results posted
Jul 23, 2026
Last update
Oct 1, 2026

Oversight

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

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