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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 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 366 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05513391
The ClinicalTrials.gov registry entry for NCT05513391 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Recombinant influenza vaccine (RIV4) is the first listed.
NCT05513391 reports 0 study locations.
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.
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