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

Completed · Phase 3

Conditions studied: Influenza Immunization

In brief

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.

Key facts

Study ID

NCT05513053

Run by

Sanofi Pasteur, a Sanofi Company

People needed

1308

Starts

2022-10-27

Expected to finish

2023-10-27

Last updated by the study team

2025-09-09

Who can join

Age: 9 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Alabama Clinical Therapeutics North Tower Site Number : 8400024 — Birmingham, Alabama, United States
• Birmingham Pediatric Associates Site Number : 8400023 — Birmingham, Alabama, United States
• The Children's Clinic Of Jonesboro PA Site Number : 8400025 — Jonesboro, Arkansas, United States
• California Research Foundation Site Number : 8400003 — San Diego, California, United States
• Meridian Clinical Research- Sioux City Site Number : 8400007 — Sioux City, Iowa, United States
• AMR - Newton Site Number : 8400021 — Newton, Kansas, United States
• Kentucky Pediatics / Adult Research Site Number : 8400010 — Bardstown, Kentucky, United States
• Velocity Clinical Research Site Number : 8400012 — New Orleans, Louisiana, United States
• Velocity Clinical Research Lincoln Site Number : 8400013 — Lincoln, Nebraska, United States
• Meridian Clinical Research Norfolk Site Number : 8400011 — Norfolk, Nebraska, United States
• Velocity Clinical Research, Omaha Site Number : 8400009 — Omaha, Nebraska, United States
• Meridian Clinical Research Site Number : 8400006 — Binghamton, New York, United States
• Velocity Clinical Research Vestal Site Number : 8400016 — Vestal, New York, United States
• Ohio Pediatric Research Site Number : 8400020 — Dayton, Ohio, United States
• Rainbow Pediatrics Site Number : 8400014 — Barnwell, South Carolina, United States
• Coastal Pediatric Research Charleston Site Number : 8400005 — Charleston, South Carolina, United States
• Coastal Carolina Research Center - N Charleston Site Number : 8400022 — North Charleston, South Carolina, United States
• Benchmark Research - Austin Site Number : 8400004 — Austin, Texas, United States
• JBR Clinical Research Site Number : 8400001 — Salt Lake City, Utah, United States
• J. Lewis Research Site Number : 8400017 — Salt Lake City, Utah, United States
• Velocity Clinical Research Portsmouth Site Number : 8400015 — Portsmouth, Virginia, United States
• Investigational Site Number : 2030001 — Jindřichův Hradec, Czechia
• Investigational Site Number : 6160010 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
• Investigational Site Number : 6160007 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
• Investigational Site Number : 6160004 — PuÅ'awy, Lubusz Voivodeship, Poland

Full record on ClinicalTrials.gov

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