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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: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04551677 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (
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 |
What the finished NCT04551677 record still lists
NCT04551677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04551677's enrollment target sits among peer trials
90 886th of 2000 higher than 1,088 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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