NCT05513391

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

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Conditions

• Influenza Immunization

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2022-08-24
• Last updated: 2025-09-09
• Results posted: 2024-07-24

Locations

31 sites across 3 countries: United States, Poland, Spain

Regulatory

• FDA-regulated drug study