NCT05513053

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

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,308 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The participation duration was approximately 6 months for each participant.

Conditions

• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH	Pharmaceutical form: Solution for injection Route of administration: intramuscular

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2022-08-23
• Last updated: 2025-09-09
• Results posted: 2024-05-30

Locations

35 sites across 4 countries: United States, Czechia, Poland, Spain

Regulatory

• FDA-regulated drug study