Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
Study on Immune Response of Investigational Vaccine in Different Age Groups
Study Overview
The purpose of this study was 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 was approximately 6 months for each participant.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Influenza Immunization
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Age: 9 years - 49 years
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Gender: All
Inclusion Criteria:
- Aged 9 to 49 years on the day of inclusion
- A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed 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 had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the immune response to an investigational vaccine in participants aged 9 to 49 years. The study aims to compare the immune response between younger participants (ages 9 to 17) and adults (ages 18 to 49) to see if the vaccine works similarly in both groups. The study also looks at how safe the vaccine is for everyone involved.
Participants will receive the investigational vaccine and will be monitored for any side effects. The study will measure the body's immune response to the vaccine, which means checking how well the body can fight off infections after getting the vaccine. This will help understand how effective and safe the vaccine is for different age groups.
- Who can participate: Participants aged 9 to 49 years can join. Females must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential. Signed consent is required.
- Study details: Participants will receive the investigational vaccine and will be monitored for immune response and safety. The study will involve checking the body's ability to fight infections after vaccination.
- Study Timelines: The study will last 6 months for each participant.