InfluenzaPhase 2NCT06560151

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

A Phase 2 study testing 3.75 µg H5N8 antigen plus full dose AS03A, 7.5 µg H5N8 antigen plus full dose AS03A and 15 µg H5N8 antigen plus full dose AS03A in people with Influenza, run by Biomedical Advanced Research and Development Authority at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: 3.75 µg H5N8 antigen plus full dose AS03A, 7.5 µg H5N8 antigen plus full dose AS03A and 15 µg H5N8 antigen plus full dose AS03A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,380 participants
Where: 20 sitesUnited States
Study dates: 21 Aug 2024to 11 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent.
Willing and able to provide written informed consent prior to initiation of study procedures.
Agrees to have specimens collected during this trial specifically for the purpose of future research stored for future research use.
In relatively stable health, as determined by medical history and physical examination.
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.
If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control 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.

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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:
menopausal >2 years
tubal ligation >1 year
bilateral salpingo-oophorectomy
hysterectomy.
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).
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.

Who cannot join

Has an acute illness, as determined by the site investigator, within 72 hours prior to vaccination.
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.
Has a history of severe reaction to any influenza vaccine.
Has a known allergy to squalene-based adjuvants.
Female of childbearing potential who has a positive urine pregnancy test or who is currently breastfeeding.
Has a body mass index >35 kg/m2 .

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Has known human immunodeficiency virus, hepatitis B, or hepatitis C infection (based on medical history).
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.
Has narcolepsy or a first degree relative with narcolepsy.
Has a history of alcohol or drug abuse within 5 years prior to Screening.
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.
Is immunosuppressed due to an underlying disease or medication, use of anticancer chemotherapy (cytotoxic), or radiation therapy.
With the exception of basal or squamous cell skin cancer, has known active neoplastic disease, including hematologic malignancy.
Has long-term use (≥14 consecutive days) of glucocorticoids 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.
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.
Has received any (licensed or under Emergency Use Authorization [EUA]) live vaccines 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).
Is participating or plans to participate in another interventional clinical trial (either active or follow-up phase) during the study period.
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).
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:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN), or
Bilirubin >1.5 times the ULN unless isolated Gilbert's syndrome.
Has any disease or medical condition that, in the opinion of the site investigator, might confound interpretation of safety or immunogenicity.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Phase 2 Study 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.

Conditions: Influenza
Being tested: 3.75 µg H5N8 antigen plus full dose AS03A, 7.5 µg H5N8 antigen plus full dose AS03A, 15 µg H5N8 antigen plus full dose AS03A, 3.75 µg H5N8 antigen plus half dose AS03A, 7.5 µg H5N8 antigen plus half dose AS03A
Keywords: A/H5, H5, Inactivated, Monovalent, Influenza, Vaccines, AS03, MF59
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3.75 µg H5N8 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus half dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus half dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus half dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
3.75 µg H5N1 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus full dose AS03ABiological
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
3.75 µg H5N1 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus MF59Biological
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.

Study groups in NCT06560151
Study group	Role	What they receive
Treatment Group A	Experimental	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. Receives: Biological: 3.75 µg H5N8 antigen plus full dose AS03A
Treatment Group B	Experimental	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. Receives: Biological: 7.5 µg H5N8 antigen plus full dose AS03A
Treatment Group C	Experimental	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. Receives: Biological: 15 µg H5N8 antigen plus full dose AS03A
Treatment Group D	Experimental	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. Receives: Biological: 3.75 µg H5N8 antigen plus half dose AS03A
Treatment Group E	Experimental	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. Receives: Biological: 7.5 µg H5N8 antigen plus half dose AS03A
Treatment Group F	Experimental	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. Receives: Biological: 15 µg H5N8 antigen plus half dose AS03A
Treatment Group G	Experimental	This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59. Receives: Biological: 3.75 µg H5N8 antigen plus MF59
Treatment Group H	Experimental	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. Receives: Biological: 7.5 µg H5N8 antigen plus MF59
Treatment Group I	Experimental	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. Receives: Biological: 15 µg H5N8 antigen plus MF59
Treatment Group J	Experimental	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. Receives: Biological: 3.75 µg H5N1 antigen plus full dose AS03A
Treatment Group K	Experimental	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. Receives: Biological: 7.5 µg H5N1 antigen plus full dose AS03A
Treatment Group L	Experimental	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. Receives: Biological: 15 µg H5N1 antigen plus full dose AS03A
Treatment Group M	Experimental	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. Receives: Biological: 3.75 µg H5N1 antigen plus MF59
Treatment Group N	Experimental	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. Receives: Biological: 7.5 µg H5N1 antigen plus MF59
Treatment Group O	Experimental	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. Receives: Biological: 15 µg H5N1 antigen plus MF59

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 through Day 8 and Day 22 through Day 29
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.
Measured: Day 1 through Day 8 and Day 22 through Day 29
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.
Measured: Day 43

Secondary outcomes (37)

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.
Measured: Day 1 through Day 22 and Day 22 through Day 43
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.
Measured: Day 1 through Day 203
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.
Measured: Day 1 through Day 203
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.
Measured: Day 1 through Day 203
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.
Measured: Day 43
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.
Measured: Screening (i.e., pre-vaccination)
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Screening (i.e., pre-vaccination)
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Day 22
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.
Measured: Day 203
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.
Measured: Day 22
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.
Measured: Day 203
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Day 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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Screening (i.e., pre-vaccination)
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Screening (i.e., pre-vaccination)
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203
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.
Measured: Day 22
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.
Measured: Day 43
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.
Measured: Day 203

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 202411 Jun 2025

First posted19 Aug 2024
Study start21 Aug 2024
Primary completion16 Jan 2025
Study completion11 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560151
Sponsor's protocol ID: BP-I-23-001
Other IDs: 75A50120D00015/75A50123F33006, 75A50120D00017/75A50123F33007
Status last verified: Sep 2026
First submitted: 15 Aug 2024
Last updated: 1 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
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RecruitingPhase 3
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Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Phase 2 Study to Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03® or MF59®
ClinicalTrials.gov ID: NCT06560151
Acronym / sponsor ID: BP-I-23-001
Conditions: Influenza
Keywords: A/H5, H5, Inactivated, Monovalent, Influenza, Vaccines, AS03, MF59
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,380 participants (actual)
Lead sponsor: Biomedical Advanced Research and Development AuthorityUS federal agency
Collaborators: Rho Federal Systems Division, Inc., ICON plc
Study start: 21 Aug 2024 (actual)
Primary completion: 16 Jan 2025 (actual)
Study completion: 11 Jun 2025 (actual)
First posted: 19 Aug 2024 (actual)
Results: Posted 23 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 15

Arm	Type	Receives
Treatment Group A	Experimental	Biological: 3.75 µg H5N8 antigen plus full dose AS03AThis 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.
Treatment Group B	Experimental	Biological: 7.5 µg H5N8 antigen plus full dose AS03AThis 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.
Treatment Group C	Experimental	Biological: 15 µg H5N8 antigen plus full dose AS03AThis 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.
Treatment Group D	Experimental	Biological: 3.75 µg H5N8 antigen plus half dose AS03AThis 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.
Treatment Group E	Experimental	Biological: 7.5 µg H5N8 antigen plus half dose AS03AThis 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.
Treatment Group F	Experimental	Biological: 15 µg H5N8 antigen plus half dose AS03AThis 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.
Treatment Group G	Experimental	Biological: 3.75 µg H5N8 antigen plus MF59This treatment group of 60 participants (ages 18-64) will receive 3.75 µg of Egg-A/Astrakhan/3212/2020 (H5N8) adjuvanted with MF59.
Treatment Group H	Experimental	Biological: 7.5 µg H5N8 antigen plus MF59This 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.
Treatment Group I	Experimental	Biological: 15 µg H5N8 antigen plus MF59This 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.
Treatment Group J	Experimental	Biological: 3.75 µg H5N1 antigen plus full dose AS03AThis 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.
Treatment Group K	Experimental	Biological: 7.5 µg H5N1 antigen plus full dose AS03AThis 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.
Treatment Group L	Experimental	Biological: 15 µg H5N1 antigen plus full dose AS03AThis 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.
Treatment Group M	Experimental	Biological: 3.75 µg H5N1 antigen plus MF59This 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.
Treatment Group N	Experimental	Biological: 7.5 µg H5N1 antigen plus MF59This 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.
Treatment Group O	Experimental	Biological: 15 µg H5N1 antigen plus MF59This 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or non-pregnant female, 18 years of age or older at the time of screening and informed consent.
Willing and able to provide written informed consent prior to initiation of study procedures.
Agrees to have specimens collected during this trial specifically for the purpose of future research stored for future research use.
In relatively stable health, as determined by medical history and physical examination.
If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control 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.

Key exclusion criteria (22 listed)

Has an acute illness, as determined by the site investigator, within 72 hours prior to vaccination.
Has a history of severe reaction to any influenza vaccine.
Has a known allergy to squalene-based adjuvants.
Female of childbearing potential who has a positive urine pregnancy test or who is currently breastfeeding.
Has a body mass index >35 kg/m2 .

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3.75 µg H5N8 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group A
7.5 µg H5N8 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group B
15 µg H5N8 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group C
3.75 µg H5N8 antigen plus half dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group D
7.5 µg H5N8 antigen plus half dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group E
15 µg H5N8 antigen plus half dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.	Biological	Treatment Group F
3.75 µg H5N8 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.	Biological	Treatment Group G
7.5 µg H5N8 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.	Biological	Treatment Group H
15 µg H5N8 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.	Biological	Treatment Group I
3.75 µg H5N1 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.	Biological	Treatment Group J
7.5 µg H5N1 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.	Biological	Treatment Group K
15 µg H5N1 antigen plus full dose AS03ATwo intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.	Biological	Treatment Group L
3.75 µg H5N1 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.	Biological	Treatment Group M
7.5 µg H5N1 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.	Biological	Treatment Group N
15 µg H5N1 antigen plus MF59Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.	Biological	Treatment Group O

Primary outcome

The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Time frame: Day 1 through Day 8 and Day 22 through Day 29
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.
The Percentage of Participants Who Experience Any Solicited Systemic Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Time frame: Day 1 through Day 8 and Day 22 through Day 29
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.
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Time frame: Day 43
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.

37 secondary outcomes

The Percentage of Participants Who Experience Any Unsolicited Treatment-emergent Adverse Event (TEAE) Within 22 Days of Each Vaccination, Inclusive of the Vaccination Day.
Time frame: Day 1 through Day 22 and Day 22 through Day 43
The Percentage of Participants Who Experience Any Treatment-emergent Serious Adverse Event (SAE).
Time frame: Day 1 through Day 203
The Percentage of Participants Who Experience Any Treatment-emergent Medically Attended Adverse Events (MAAE).
Time frame: Day 1 through Day 203
The Percentage of Participants Who Experience Any Treatment-emergent Potentially Immune-mediated Disease (pIMD).
Time frame: Day 1 through Day 203
The Percentage of Participants Achieving Seroprotection at Day 43 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Time frame: Day 43
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Screening.
Time frame: Screening (i.e., pre-vaccination)
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 22.
Time frame: Day 22
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 43.
Time frame: Day 43
Serum HAI Antibody Titers to A/Astrakhan (H5N8) at Day 203.
Time frame: Day 203
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
Time frame: Screening (i.e., pre-vaccination)
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
Time frame: Day 22
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
Time frame: Day 43
Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203
Time frame: Day 203
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Time frame: Day 22
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Astrakhan (H5N8).
Time frame: Day 203
The Percentage of Participants Achieving Seroprotection at Day 22 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Time frame: Day 22
The Percentage of Participants Achieving Seroprotection at Day 203 Based on Serum HAI Antibody Titers (≥1:40) to A/Bar-headed Goose (H5N1).
Time frame: Day 203
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 22
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 43
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 203
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 22
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 43
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum HAI Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 203
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Screening.
Time frame: Screening (i.e., pre-vaccination)
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 22.
Time frame: Day 22
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 43.
Time frame: Day 43
Serum MN Antibody Titers to A/Astrakhan (H5N8) at Day 203.
Time frame: Day 203
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Screening.
Time frame: Screening (i.e., pre-vaccination)
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 22.
Time frame: Day 22
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 43.
Time frame: Day 43
Serum MN Antibody Titers to A/Bar-headed Goose (H5N1) at Day 203.
Time frame: Day 203
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 22
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 43
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Astrakhan (H5N8).
Time frame: Day 203
The Percentage of Participants Achieving Seroconversion at Day 22 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 22
The Percentage of Participants Achieving Seroconversion at Day 43 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 43
The Percentage of Participants Achieving Seroconversion at Day 203 Based on Serum MN Antibody Titers to A/Bar-headed Goose (H5N1).
Time frame: Day 203

Results and safety

Results posted to the registry on 23 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3.75 µg H5N8 Plus AS03A Full Dose	61	55
7.5 µg H5N8 Plus AS03A Full Dose	121	110
15 µg H5N8 Plus AS03A Full Dose	121	108
3.75 µg H5N8 Plus AS03A Half Dose	60	53
7.5 µg H5N8 Plus AS03A Half Dose	119	110
15 µg H5N8 Plus AS03A Half Dose	120	110
3.75 µg H5N8 Plus MF59	60	55
7.5 µg H5N8 Plus MF59	120	112
15 µg H5N8 Plus MF59	119	109
3.75 µg H5N1 Plus AS03A Full Dose	60	55
7.5 µg H5N1 Plus AS03A Full Dose	118	112
15 µg H5N1 Plus AS03A Full Dose	59	58
3.75 µg H5N1 Plus MF59	60	55
7.5 µg H5N1 Plus MF59	121	113
15 µg H5N1 Plus MF59	61	58

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

Time frame: Day 1 through Day 8 and Day 22 through Day 29. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	3.75 µg H5N8 Plus AS03A Full Dose n = 61	7.5 µg H5N8 Plus AS03A Full Dose n = 121	15 µg H5N8 Plus AS03A Full Dose n = 121	3.75 µg H5N8 Plus AS03A Half Dose n = 60	7.5 µg H5N8 Plus AS03A Half Dose n = 119	15 µg H5N8 Plus AS03A Half Dose n = 120	3.75 µg H5N8 Plus MF59 n = 60	7.5 µg H5N8 Plus MF59 n = 120	15 µg H5N8 Plus MF59 n = 119	3.75 µg H5N1 Plus AS03A Full Dose n = 60	7.5 µg H5N1 Plus AS03A Full Dose n = 118	15 µg H5N1 Plus AS03A Full Dose n = 59	3.75 µg H5N1 Plus MF59 n = 60	7.5 µg H5N1 Plus MF59 n = 121	15 µg H5N1 Plus MF59 n = 61
18-64 years	62.3 (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)
Overall	62.3 (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)

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

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

Time frame: Day 1 through Day 8 and Day 22 through Day 29. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	3.75 µg H5N8 Plus AS03A Full Dose n = 61	7.5 µg H5N8 Plus AS03A Full Dose n = 121	15 µg H5N8 Plus AS03A Full Dose n = 121	3.75 µg H5N8 Plus AS03A Half Dose n = 60	7.5 µg H5N8 Plus AS03A Half Dose n = 119	15 µg H5N8 Plus AS03A Half Dose n = 120	3.75 µg H5N8 Plus MF59 n = 60	7.5 µg H5N8 Plus MF59 n = 120	15 µg H5N8 Plus MF59 n = 119	3.75 µg H5N1 Plus AS03A Full Dose n = 60	7.5 µg H5N1 Plus AS03A Full Dose n = 118	15 µg H5N1 Plus AS03A Full Dose n = 59	3.75 µg H5N1 Plus MF59 n = 60	7.5 µg H5N1 Plus MF59 n = 121	15 µg H5N1 Plus MF59 n = 61
18-64 years	50.8 (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)
Overall	50.8 (37.7 to 63.9)

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

Time frame: Day 43. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	3.75 µg H5N8 Plus AS03A Full Dose n = 56	7.5 µg H5N8 Plus AS03A Full Dose n = 102	15 µg H5N8 Plus AS03A Full Dose n = 106	3.75 µg H5N8 Plus AS03A Half Dose n = 55	7.5 µg H5N8 Plus AS03A Half Dose n = 112	15 µg H5N8 Plus AS03A Half Dose n = 109	3.75 µg H5N8 Plus MF59 n = 56	7.5 µg H5N8 Plus MF59 n = 110	15 µg H5N8 Plus MF59 n = 108	3.75 µg H5N1 Plus AS03A Full Dose n = 50	7.5 µg H5N1 Plus AS03A Full Dose n = 111	15 µg H5N1 Plus AS03A Full Dose n = 55	3.75 µg H5N1 Plus MF59 n = 49	7.5 µg H5N1 Plus MF59 n = 114	15 µg H5N1 Plus MF59 n = 59
18-64 years	87.5 (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)

Population analysed: Immunogenicity per protocol population included all participants who received a full dose of vaccine at Days 1 and 22 as assigned by randomization within -3/+14 days of the expected date, had determinate assay results at the Day 43 visit within -7/+14 days of the expected date, and had no major protocol deviations impacting immunogenicity.

37 secondary outcomes are reported in the full results.

Adverse events

Time frame: From receipt of the first vaccination until exit from the study, which was planned to occur 202 days after the date of initial vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3.75 µg H5N8 Plus AS03A Full Dose	0 of 61 (0%)	46 of 61 (75.4%)	0 of 61
7.5 µg H5N8 Plus AS03A Full Dose	1 of 121 (0.8%)	77 of 121 (63.6%)	0 of 121
15 µg H5N8 Plus AS03A Full Dose	1 of 121 (0.8%)	74 of 121 (61.2%)	0 of 121
3.75 µg H5N8 Plus AS03A Half Dose	0 of 60 (0%)	31 of 60 (51.7%)	0 of 60
7.5 µg H5N8 Plus AS03A Half Dose	2 of 119 (1.7%)	73 of 119 (61.3%)	0 of 119
15 µg H5N8 Plus AS03A Half Dose	1 of 120 (0.8%)	75 of 120 (62.5%)	0 of 120
3.75 µg H5N8 Plus MF59	1 of 60 (1.7%)	38 of 60 (63.3%)	0 of 60
7.5 µg H5N8 Plus MF59	7 of 120 (5.8%)	52 of 120 (43.3%)	0 of 120
15 µg H5N8 Plus MF59	1 of 119 (0.8%)	43 of 119 (36.1%)	0 of 119
3.75 µg H5N1 Plus AS03A Full Dose	0 of 60 (0%)	45 of 60 (75%)	0 of 60
7.5 µg H5N1 Plus AS03A Full Dose	1 of 118 (0.8%)	79 of 118 (66.9%)	0 of 118
15 µg H5N1 Plus AS03A Full Dose	1 of 59 (1.7%)	35 of 59 (59.3%)	0 of 59
3.75 µg H5N1 Plus MF59	0 of 60 (0%)	33 of 60 (55%)	0 of 60
7.5 µg H5N1 Plus MF59	2 of 121 (1.7%)	53 of 121 (43.8%)	0 of 121
15 µg H5N1 Plus MF59	0 of 61 (0%)	27 of 61 (44.3%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day. (time frame: Day 1 through Day 8 and Day 22 through Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.