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NCT05050318 · ClinicalTrials.gov registry record · Phase 4
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
A Phase 4 study of Healthy Volunteers and Influenza Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT05050318 is a Phase 4 study of Healthy Volunteers and Influenza Immunization that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05050318, a Phase 4 study of Healthy Volunteers and Influenza Immunization, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.
Conditions Studied
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation
- BIOLOGICAL Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
Study Locations (2)
Kentucky
- Investigational Site Number :8400001 - Bardstown
Utah
- Investigational Site Number :8400002 - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2021-11-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05050318
The ClinicalTrials.gov registry entry for NCT05050318 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (81% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation is the first listed.
NCT05050318 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kentucky, Utah.
Frequently Asked Questions
What is clinical trial NCT05050318 about?
NCT05050318 is a clinical study titled "Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively". This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for s...
What is the current status of trial NCT05050318?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2021-09-08. Estimated completion is 2021-11-10.
What conditions does trial NCT05050318 study?
This clinical trial studies the following conditions: Healthy Volunteers, Influenza Immunization.
What interventions are being tested in trial NCT05050318?
The interventions under investigation include: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation (BIOLOGICAL), Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05050318?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05050318 being conducted?
This trial has 2 study locations across Kentucky, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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