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

Study on How the Body's Defense System Reacts to Vaccines That Protect Against the Flu in Young 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 immune response to two types of influenza vaccines in children aged 3 to 8 years. The purpose is to compare the immune response generated by a quadrivalent recombinant influenza vaccine (RIV4) with that of a licensed egg-based quadrivalent influenza vaccine (IIV4). The study aims to determine if the immune response from RIV4 is not inferior to that from IIV4 for the four strains of the virus based on egg-derived antigens.

Participants in the study received either one or two doses of the vaccines, depending on their previous vaccination history. Those who had never been vaccinated against influenza received two doses 28 days apart, while those who had been previously vaccinated received one dose. The study followed participants for six months after their last vaccination to assess immunogenicity and safety.

  • Who can participate: Children aged 3 to 8 years with signed assent and parental consent can participate. Exclusions include known immunodeficiencies or hypersensitivity to vaccine components.
  • Study details: Participants will receive either one or two doses of the investigational vaccine or the egg-based vaccine, depending on their vaccination history. The study involves monitoring the immune response and safety over a six-month period.
  • Study timelines: The study will last 6 months.
Updated on 09 Sep 2025. Study ID: NCT05513391