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

Phase 3 Completed 1308 enrolled Sanofi Pasteur, a Sanofi Company

Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2022-10-27
Primary completion: 2023-10-27
Completion: 2023-10-27

Outcome

Met primary endpoint

paper lower limit of the two-sided 95% CI of the geometric mean titre (GMT) ratio was above 0·667 PMID 40412421 ↗

paper RIV4 induced non-inferior immune responses in the participants aged 9-17 years compared with those aged 18-49 years. PMID 40412421 ↗

Publications

Folegatti PM, Pepin S, Tabar C, Fries K, Talanova O, See S, Essink B, Bertoch T, Drazan D, Natalini Martinez S, Konieczny M, Kaas-Leach K, De Bruijn I. Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study. Lancet Infect Dis. 2025 Oct;25(10):1097-1105. doi: 10.1016/S1473-3099(25)00153-7. Epub 2025 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RIV4	Vaccine	—	Intramuscular

Indications

No indication recorded.