Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
Investigating Immune Response to Influenza Vaccines in Children
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
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Age: 3 years - 8 years
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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 of a quadrivalent recombinant influenza vaccine compared to an egg-based quadrivalent influenza vaccine in children aged 3 to 8 years. The purpose is to see if the new vaccine can provide a similar level of immune protection as the existing option. The study also looks at how safe the new vaccine is for these children.
Participants in this study will receive either one or two doses of the investigational vaccine or the egg-based vaccine, depending on their previous vaccination history. Children who have never been vaccinated against influenza will receive two doses, 28 days apart, while those who have been vaccinated before will receive one dose. The children will be monitored for six months after their last vaccination to track the vaccine's effects and safety.
- Who can participate: Children aged 3 to 8 years who have signed an assent form and whose parents or guardians have provided consent can participate. Key eligibility factors include no history of severe allergic reactions to vaccines, no significant immune deficiencies, and no recent use of immunosuppressive treatments.
- Study details: Participants will receive either the investigational vaccine or the egg-based vaccine, with one or two doses depending on their vaccination history. They will be monitored for six months to assess the vaccine's effects and safety.
- Study timelines: The study will last 6 months.
