This study is currently not recruiting participants.

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

Study of Investigational Influenza Vaccines in Children

Not Recruiting
3 years - 8 years
All
Phase 3
366 participants needed

Study Overview

The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

Study Details

Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Eligibility Criteria

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

  • Conditions: Influenza Immunization
  • Age: 3 years - 8 years
  • Gender: All

Inclusion Criteria:

  • Aged 3 to 8 years on the day of inclusion
  • Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations

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

This study investigates the quadrivalent recombinant influenza vaccine (RIV4) compared to the egg-based quadrivalent influenza vaccine (IIV4) in children aged 3 to 8 years. It focuses on the immune response to the vaccines.

The study evaluates the safety and effectiveness of RIV4 compared to IIV4 in young children. It looks at how well the vaccines work and their safety profiles.

  • Who can participate: Children aged 3 to 8 years who have signed an assent form and whose parents have signed a consent form can participate. Participants should not have a history of certain medical conditions or be on specific medications.
  • Study details: Participants received either the investigational vaccine or the egg-based vaccine. Some received one dose, while others received two doses 28 days apart, based on their vaccination history.
  • Study timelines: The study will last 6 months.
Updated on 09 Sep 2025. Study ID: NCT05513391