NCT05144945

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

A Phase III Randomized, Modified Double-blind, Active-controlled, Multi-center Study to Describe the Immunogenicity and Safety of the Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The duration of each participant's participation was approximately 6 months.

Conditions

• Influenza (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Recombinant Influenza Vaccine (RIV4)	Solution for intramuscular injection
BIOLOGICAL	Quadrivalent inactivated influenza vaccine (IIV4)	Suspension for intramuscular injection

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-12-06
• Last updated: 2025-09-11
• Results posted: 2023-09-29

Locations

3 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study