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

Stopped early · Phase 3

Conditions studied: Influenza Immunization

In brief

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.

Key facts

Study ID

NCT05513391

Run by

Sanofi Pasteur, a Sanofi Company

People needed

366

Starts

2022-11-10

Expected to finish

2023-10-03

Last updated by the study team

2025-09-09

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Where it is running

• 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 Pediatrics / Adult Research Site Number : 8400010 — Bardstown, Kentucky, United States
• Velocity Clinical Research- New Orleans Site Number : 8400012 — New Orleans, Louisiana, United States
• Velocity Clinical Research Lincoln Site Number : 8400013 — Lincoln, 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 Site Number : 8400022 — North Charleston, South Carolina, 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
• Alliance for Multispecialty Research Syracuse Site Number : 8400027 — Syracuse, Utah, United States
• Investigational Site Number : 6160010 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
• Investigational Site Number : 6160007 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
• Investigational Site Number : 6160005 — Siemianowice Śląskie, Silesian Voivodeship, Poland
• Investigational Site Number : 6160003 — Bydgoszcz, Poland
• Investigational Site Number : 6160006 — Tarnów, Poland
• Investigational Site Number : 6160001 — Warsaw, Poland
• Investigational Site Number : 6160012 — Wroclaw, Poland

Full record on ClinicalTrials.gov

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