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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: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03617523 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 240 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.
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 |
What the finished NCT03617523 record still lists
NCT03617523 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Fluzone Quadrivalent vaccine, 2018-2019 formulation is the first listed.
NCT03617523 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03617523's enrollment target sits among peer trials
240 360th of 2000 higher than 1,635 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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