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NCT04109222 · ClinicalTrials.gov registry record · Phase 4
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT04109222 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04109222, a Phase 4 study of Influenza, 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
The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Conditions Studied
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation
- BIOLOGICAL Fluzone High-Dose vaccine, 2019-2020 formulation
Study Locations (2)
Kentucky
- Investigational Site Number 8400002 - Bardstown
Utah
- Investigational Site Number 8400001 - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2019-12-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04109222
The ClinicalTrials.gov registry entry for NCT04109222 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 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation is the first listed.
NCT04109222 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kentucky, Utah.
Frequently Asked Questions
What is clinical trial NCT04109222 about?
NCT04109222 is a clinical study titled "Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively". The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Center...
What is the current status of trial NCT04109222?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2019-09-30. Estimated completion is 2019-12-10.
What conditions does trial NCT04109222 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT04109222?
The interventions under investigation include: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (BIOLOGICAL), Fluzone High-Dose vaccine, 2019-2020 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT04109222?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04109222 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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