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NCT02908269 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT02908269: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02908269 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 180 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02908269, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study Summary
The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Primary Observational Objectives * To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and adults 18 to \< 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. * To submit available sera from approximately 90 participants (30 participants 3 to \< 9 years of age and 30 participants 18 to \< 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to 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.
Primary Outcome
Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema \& swelling (Grade 1: \>0 to \<25 mm;Grade 2: ≥ 25 to \< 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), hea
Interventions
- BIOLOGICAL Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative
- BIOLOGICAL Fluzone High-Dose, vaccine, 2016-2017 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2016-09-15 |
| Est. Completion | 2016-12-09 |
| Phase | Phase 4 |
What the finished NCT02908269 record still lists
NCT02908269 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative is the first listed.
NCT02908269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02908269 about?
NCT02908269 is a clinical study titled "Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations". The aim of the study was to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to \< 9 years of age and in adults 18 to \< 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥65 years of age. Prima...
What is the current status of trial NCT02908269?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2016-09-15. Estimated completion is 2016-12-09.
What interventions are being tested in trial NCT02908269?
The interventions under investigation include: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative (BIOLOGICAL), Fluzone High-Dose, vaccine, 2016-2017 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02908269?
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 NCT02908269's enrollment target sits among peer trials
180 466th of 2000 higher than 1,525 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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