Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different A… (NCT06560151) | Clinical Trial Compass
CompletedPhase 2
Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines at Different Antigen Dose Levels Adjuvanted With AS03 or MF59
United States1,380 participantsStarted 2024-08-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Percentage of Participants Who Experience Any Solicited Local Reactogenicity Symptom Occurring Within 8 Days of Each Vaccination, Inclusive of the Vaccination Day.
Timeframe: 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.
Timeframe: 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).
Timeframe: Day 43
Trial details
NCT IDNCT06560151
SponsorBiomedical Advanced Research and Development Authority
. 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 .
. 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.