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

NCT05513053

CompletedPhase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Influenza Immunization

Interventions: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH

Countries: United States, Czechia, Poland, Spain

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.

Eligibility overview

Sex: ALL

Age: 9 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (35)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Jonesboro, Arkansas, United States
  • San Diego, California, United States
  • Sioux City, Iowa, United States
  • Newton, Kansas, United States
  • Bardstown, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Lincoln, Nebraska, United States
  • Norfolk, Nebraska, United States
  • Omaha, Nebraska, United States
  • Binghamton, New York, United States
  • Vestal, New York, United States
  • Dayton, Ohio, United States
  • Barnwell, South Carolina, United States
  • Charleston, South Carolina, United States
  • North Charleston, South Carolina, United States
  • Austin, Texas, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States
  • Portsmouth, Virginia, United States
  • Jindřichův Hradec, Czechia
  • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • PuÅ'awy, Lubusz Voivodeship, Poland
  • Siemianowice Śląskie, Silesian Voivodeship, Poland
  • Bydgoszcz, Poland
  • Tarnów, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • + 5 more on CT.gov