CompletedPhase 2

Study to Evaluate Safety and Immunogenicity of Different Priming and Booster Regimens With Adjuvanted H5N8 and/or H5N6 Influenza Vaccine in Adults

United States480 participantsStarted 2023-06-07

Plain-language summary

This Phase 2, randomized, observer-blind clinical study is evaluating 3 different priming and booster regimens with MF59-adjuvanted H5N8 and/or H5N6 cell culture-derived influenza vaccine (aH5N8c; aH5N6c). Approximately 480 healthy adult subjects are to be randomized into 1 of 3 possible treatment groups, stratified by age group (18-64 years and ≥65 years) and by poultry worker status (yes/no). Each subject will receive a priming influenza vaccine injection on Day 1 and Day 22 and a booster vaccination on Day 202. Subjects will be followed up for approximately 6 months after the booster injection. The primary immunogenicity analysis is based on antibody responses against H5N8 and H5N6 as measured by hemagglutination inhibition (HI) assay on Day 1, Day 22, Day 29, Day 43, Day 202, Day 209 (H5N8 only), and Day 223.

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.

Exclusion criteria

. Clinical conditions.
. Systemic administration of corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

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

Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1

Timeframe: Day 1

GMT of HI antibodies against H5N8 strain - Day 22

Timeframe: Day 22

GMT of HI antibodies against H5N8 strain - Day 43

Timeframe: Day 43

GMT of HI antibodies against H5N8 strain - Day 202

Timeframe: Day 202

GMT of HI antibodies against H5N8 strain - Day 209

Timeframe: Day 209

GMT of HI antibodies against H5N8 strain - Day 223

Timeframe: Day 223

GMT of HI antibodies against H5N6 strain - Day 1

Timeframe: Day 1

Trial details

NCT IDNCT05874713

SponsorSeqirus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-25

View on ClinicalTrials.gov More Influenza, Human trials

Plain-language summary

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.

Exclusion criteria

. Clinical conditions.
. Systemic administration of corticosteroids at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.

What they're measuring

Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against H5N8 strain - Day 1

Timeframe: Day 1

GMT of HI antibodies against H5N8 strain - Day 22

Timeframe: Day 22

GMT of HI antibodies against H5N8 strain - Day 43

Timeframe: Day 43

GMT of HI antibodies against H5N8 strain - Day 202

Timeframe: Day 202

GMT of HI antibodies against H5N8 strain - Day 209

Timeframe: Day 209

GMT of HI antibodies against H5N8 strain - Day 223

Timeframe: Day 223

GMT of HI antibodies against H5N6 strain - Day 1

Timeframe: Day 1