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NCT05513391 · ClinicalTrials.gov registry record · Phase 3
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT05513391: Clinical Trial Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05513391 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05513391, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study 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.
Primary Outcome
GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
Interventions
- BIOLOGICAL Recombinant influenza vaccine (RIV4)
- BIOLOGICAL Quadrivalent influenza vaccine (IIV4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2022-11-10 |
| Est. Completion | 2023-10-03 |
| Phase | Phase 3 |
Why NCT05513391 stopped before completion
NCT05513391 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Recombinant influenza vaccine (RIV4) is the first listed.
NCT05513391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05513391 about?
NCT05513391 is a clinical study titled "Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years". 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 ...
What is the current status of trial NCT05513391?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2022-11-10. Estimated completion is 2023-10-03.
What interventions are being tested in trial NCT05513391?
The interventions under investigation include: Recombinant influenza vaccine (RIV4) (BIOLOGICAL), Quadrivalent influenza vaccine (IIV4) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05513391?
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 NCT05513391's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 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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