CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,308 enrolled
Drug / intervention
Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHbiological
Likely dose
Quadrivalent recombinant influenza vaccine (RIV4) intramuscular injection, single dose (season 2022–2023)AI-extracted
Key inclusion· 3
  • ✓Aged 9 to 49 years on the day of inclusion
  • ✓Female participants must not be pregnant or breastfeeding, and either be of non-childbearing potential or use effective contraception from 4 weeks before first vaccine through 4 weeks after last vaccine
  • ✓Informed consent or assent form signed by participant or legally acceptable representative
Key exclusion· 7
  • ✕Known or suspected congenital or acquired immunodeficiency
  • ✕Receipt of immunosuppressive therapy (e.g., anti-cancer chemotherapy, radiation) within 6 months, or long-term systemic corticosteroids (prednisone or equivalent >2 weeks) within 3 months
  • ✕Known systemic hypersensitivity to vaccine components or history of life-threatening reaction to the vaccines used in the trial
  • ✕Thrombocytopenia

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

Search/NCT05513053
NCT05513053Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 23, 2022·Updated Sep 9, 2025

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH for Influenza Immunization. Completed, enrolled 1,308 participants across 35 sites in 4 countries.

Detailed Summary

The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Immunization
CountriesCzechia, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedAug 23, 2022
Enrollment StartOct 27, 2022
Primary CompletionOct 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 3.9 years ago

Interventions

Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NHbiological

Pharmaceutical form: Solution for injection Route of administration: intramuscular