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

Study Overview

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.

Study details

The study duration for each participant will be approximately 13 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Influenza, Healthy Volunteers
  • Age: 18 Years
  • Gender: All

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
             history of a life-threatening reaction to the study interventions used in the study or
             to a product containing any of the same substances
          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based
             on investigator's judgement
          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with study conduct or completion (1)
             (1) Chronic illness may include, but is not limited to, cardiac disorders, renal
             disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic
             infection
          -  Neoplastic disease or any hematologic malignancy (except localized skin or prostate
             cancer that is stable at the time of study intervention administration in the absence
             of therapy, and participants who have a history of neoplastic disease and who have
             been disease-free for ≥ 5 years)
          -  Moderate or severe acute illness/infection (according to investigator judgment) or
             febrile illness (temperature ≥ 100.4°F) on the day of study intervention
             administration. A prospective participant should not be included in the study until
             the condition has resolved or the febrile event has subsided
          -  Alcohol, prescription drug, or substance abuse that, in the opinion of the
             Investigator, might interfere with the study conduct or completion
          -  Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any
             vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at
             least 2 weeks after Visit 2
          -  Previous vaccination against H7N9 with an investigational vaccine
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months
          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             study intervention administration) or planned participation during the present study
             period in another clinical study investigating a vaccine, drug, medical device, or
             medical procedure
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily
          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (ie, parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study
          -  Personal or family history of Guillain-Barré syndrome
          -  Self-reported seropositivity for Hepatitis B antigen or Hepatitis C
        "The above information is not intended to contain all considerations relevant to a
        potential participation in a clinical trial."

Updated on 12 Mar 2024. Study ID: NCT05608005