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NCT05513053 · ClinicalTrials.gov registry record · Phase 3
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,308
- Enrollment target
NCT05513053: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05513053 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,308 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05513053, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,308 participants
- Enrollment target
Study 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.
Primary Outcome
GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Interventions
- BIOLOGICAL Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,308 participants |
| Start Date | 2022-10-27 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 3 |
What the finished NCT05513053 record still lists
NCT05513053 is an interventional study that assigns participants to a tested intervention. Its 1,308 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 1 intervention - of which Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH is the first listed.
NCT05513053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05513053 about?
NCT05513053 is a clinical study titled "Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.". 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.
What is the current status of trial NCT05513053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,308 participants. The study started on 2022-10-27. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT05513053?
The interventions under investigation include: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH (BIOLOGICAL).
Who is sponsoring clinical trial NCT05513053?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05513053's enrollment target sits among peer trials
1,308 188th of 2000 higher than 1,813 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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