CompletedPhase 1/2

Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older

United States581 participantsStarted 2022-11-03

Plain-language summary

VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.

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: * Aged 18 years or older on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration. * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention * Informed consent form has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components, or …

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 of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22

Timeframe: Day 22

Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43

Timeframe: Day 43

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22

Timeframe: Days 1 and 22

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43

Timeframe: Days 1 and 43

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202

Timeframe: Days 1 and 202

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387

Timeframe: Days 1 and 387

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22

Timeframe: Day 22

Trial details

NCT IDNCT05608005

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-18

Results submitted2025-01-28

View on ClinicalTrials.gov More Influenza 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.

What they're measuring

Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22

Timeframe: Day 22

Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43

Timeframe: Day 43

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22

Timeframe: Days 1 and 22

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43

Timeframe: Days 1 and 43

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202

Timeframe: Days 1 and 202

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387

Timeframe: Days 1 and 387

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22

Timeframe: Day 22