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Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

NCT05513391 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2025-09-09

Study results available
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Summary

The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

Conditions

  • Influenza Immunization

Interventions

BIOLOGICAL

Recombinant influenza vaccine (RIV4)

Pharmaceutical form: solution for injection Route of administration: intramuscular

BIOLOGICAL

Quadrivalent influenza vaccine (IIV4)

Pharmaceutical form: suspension for injection Route of administration: intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States
  • Poland
  • Spain

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 NCT05513391 on ClinicalTrials.gov