Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.

Study Overview

The purpose of this study is to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

Study details

The participation duration will be approximately 6 months for each participant.

Eligibility Criteria

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

  • Conditions:
    Influenza Immunization
  • Age: Between 9 Years - 49 Years
  • Gender: All

Inclusion Criteria:

  • Aged 9 to 49 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
  • Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and if applicable informed consent form has been signed and dated by the parent(s) or another legally acceptable representative

Exclusion Criteria:

  • 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 vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Thrombocytopenia
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
  • Personal or family history of Guillain-Barre Syndrome (GBS)
  • Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 17 Jan 2024. Study ID: NCT05513053