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NCT04551677 · ClinicalTrials.gov registry record · Phase 4
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
NCT04551677 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants.
The verdict
NCT04551677, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
Study Summary
Primary Objective: To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation
- BIOLOGICAL Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2020-12-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04551677
The ClinicalTrials.gov registry entry for NCT04551677 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. 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 Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation is the first listed.
NCT04551677 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04551677 about?
NCT04551677 is a clinical study titled "Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively". Primary Objective: To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Cont...
What is the current status of trial NCT04551677?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2020-09-16. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT04551677?
The interventions under investigation include: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation (BIOLOGICAL), Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT04551677?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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