Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
NCT ID: NCT06560151
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1380 participants
INTERVENTIONAL
2024-08-21
2025-06-11
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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.
3.75 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
7.5 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
15 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
3.75 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
7.5 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
15 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
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.
3.75 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
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.
7.5 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
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.
15 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
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.
3.75 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
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.
7.5 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
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.
15 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
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.
3.75 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
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.
7.5 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
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.
15 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
Interventions
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15 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus half dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
7.5 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
15 µg H5N8 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N8 vaccine.
3.75 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N1 vaccine.
3.75 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
7.5 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
15 µg H5N1 antigen plus MF59
Two intramuscular doses (21 days apart) of MF59 adjuvanted H5N1 vaccine.
7.5 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
3.75 µg H5N8 antigen plus full dose AS03A
Two intramuscular doses (21 days apart) of AS03A adjuvanted H5N8 vaccine.
Eligibility Criteria
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Inclusion Criteria
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 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.
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
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 childbearing potential who has a positive urine pregnancy test or who is currently breastfeeding.
5. Has a body mass index \>35 kg/m2 .
6. Has known human immunodeficiency virus, hepatitis B, or hepatitis C 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 immunosuppressed 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 malignancy.
13. 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.
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 \[EUA\]) 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).
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. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times the upper limit of normal (ULN), or
2. Bilirubin \>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.
18 Years
ALL
Yes
Sponsors
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Rho Federal Systems Division, Inc.
INDUSTRY
ICON plc
INDUSTRY
Biomedical Advanced Research and Development Authority
FED
Responsible Party
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Locations
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DelRicht Research - Atlanta
Atlanta, Georgia, United States
Javara Research - Privia Medical Group Georgia
Savannah, Georgia, United States
Accellacare - Duly Health and Care - Oak Lawn
Oak Lawn, Illinois, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States
Alliance for Multispecialty Research - Wichita East - Heartland Research Associates
Wichita, Kansas, United States
Alliance for Multispecialty Research - Lexington
Lexington, Kentucky, United States
DelRicht Research - New Orleans - Prytania Street
New Orleans, Louisiana, United States
DelRicht Research - Prairieville
Prairieville, Louisiana, United States
Rochester Clinical Research
New York, New York, United States
Accellacare - Cary
Cary, North Carolina, United States
Accellacare of Hickory
Hickory, North Carolina, United States
Accellacare - Piedmont Healthcare
Statesville, North Carolina, United States
Accellacare - Tradd Court
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
DelRicht Research - Tulsa
Tulsa, Oklahoma, United States
Tekton Research - Oklahoma - Primary Health Partners
Yukon, Oklahoma, United States
Tekton Research - Austin
Austin, Texas, United States
Javara Research - Privia Medical Group Gulf Coast
Conroe, Texas, United States
Tekton Research - San Antonio
San Antonio, Texas, United States
DelRicht Research - Virgina
Sterling, Virginia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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BP-I-23-001
Identifier Type: -
Identifier Source: org_study_id
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