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NCT03617523 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
NCT03617523 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 240 participants.
The verdict
NCT03617523, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
Study Summary
The primary objectives of this study were: * To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (\<) 36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to \<65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (\>=) 65 years of age. * To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to \<65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults \>=65 years of age.
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, 2018-2019 formulation
- BIOLOGICAL Flublok Quadrivalent vaccine, 2018-2019 formulation
- BIOLOGICAL Fluzone High-Dose vaccine, 2018-2019 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2018-11-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03617523
The ClinicalTrials.gov registry entry for NCT03617523 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 240 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 3 interventions - of which Fluzone Quadrivalent vaccine, 2018-2019 formulation is the first listed.
NCT03617523 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03617523 about?
NCT03617523 is a clinical study titled "Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations". The primary objectives of this study were: * To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (\<) 36 months of age and 3 to \<9 years of age, and in adults 18 to \<65 years of age; the immunogenicity of the 2018-2019 formulatio...
What is the current status of trial NCT03617523?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2018-09-10. Estimated completion is 2018-11-12.
What interventions are being tested in trial NCT03617523?
The interventions under investigation include: Fluzone Quadrivalent vaccine, 2018-2019 formulation (BIOLOGICAL), Flublok Quadrivalent vaccine, 2018-2019 formulation (BIOLOGICAL), Fluzone High-Dose vaccine, 2018-2019 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT03617523?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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