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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

NCT05144945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-09-11

Study results available
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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.

Conditions

  • Influenza (Healthy Volunteers)

Interventions

BIOLOGICAL

Quadrivalent Recombinant Influenza Vaccine (RIV4)

Solution for intramuscular injection

BIOLOGICAL

Quadrivalent inactivated influenza vaccine (IIV4)

Suspension for intramuscular injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144945 on ClinicalTrials.gov