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 range18 Years

SexALL

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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 …

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

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43

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 range18 Years

SexALL

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

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43