Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea

Phase 3 Completed 301 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindPrevention

Summary

* To describe the immune response induced by quadrivalent recombinant influenza vaccine (RIV4) and Quadrivalent-inactivated Influenza Vaccine (IIV4) in 18-49 and greater than or equal to (\>=) 50 years of age participants by hemagglutination inhibition (HAI) measurement method. * To describe the safety profile of all participants in RIV4 and IIV4 groups.

Timeline

Start: 2021-12-07
Primary completion: 2022-09-01
Completion: 2022-09-01

Publications

Choi WS, Lee J, Ottaviano C, Samson S, Peng L, Shin S, Choe S, Kim WJ. Immunogenicity and safety of quadrivalent recombinant influenza vaccine in Korean adults: Phase III, randomized study. Vaccine. 2025 Aug 30;62:127521. doi: 10.1016/j.vaccine.2025.127521. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flublok Quadrivalent	Vaccine	0.5 ml	Intramuscular
Comparator	Influenza Virus Vaccine	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.