CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
Quadrivalent Recombinant Influenza Vaccine (RIV4) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05144945
NCT05144945Phase 3Completed
CompareCT.gov

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

Sanofi Pasteur, a Sanofi Company·interventional·Posted Dec 6, 2021·Updated Sep 11, 2025

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Recombinant Influenza Vaccine (RIV4) and Quadrivalent inactivated influenza vaccine (IIV4) for Influenza (Healthy Volunteers). Completed, enrolled 301 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza (Healthy Volunteers)
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedDec 6, 2021
Enrollment StartDec 7, 2021
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.6 years ago

Interventions

Quadrivalent Recombinant Influenza Vaccine (RIV4)biological

Solution for intramuscular injection

Quadrivalent inactivated influenza vaccine (IIV4)biological

Suspension for intramuscular injection