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NCT02258334 · ClinicalTrials.gov registry record · Phase 4
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 208
- Enrollment target
NCT02258334: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02258334 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 208 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02258334, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 208 participants
- Enrollment target
Study Summary
The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Objectives: * To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age. Observational objectives: * To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone ®High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
Primary Outcome
Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Interventions
- BIOLOGICAL Fluzone® Quadrivalent vaccine, 2014-2015 formulation
- BIOLOGICAL Fluzone I®ntradermal vaccine, 2014-2015 formulation
- BIOLOGICAL Fluzone High Dose vaccine, 2014-2015 formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2014-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT02258334 record still lists
NCT02258334 is an interventional study that assigns participants to a tested intervention. The registered 208 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 (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Fluzone® Quadrivalent vaccine, 2014-2015 formulation is the first listed.
NCT02258334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02258334 about?
NCT02258334 is a clinical study titled "Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults". The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \< 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 ye...
What is the current status of trial NCT02258334?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2014-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02258334?
The interventions under investigation include: Fluzone® Quadrivalent vaccine, 2014-2015 formulation (BIOLOGICAL), Fluzone I®ntradermal vaccine, 2014-2015 formulation (BIOLOGICAL), Fluzone High Dose vaccine, 2014-2015 formulation (BIOLOGICAL).
Who is sponsoring clinical trial NCT02258334?
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 NCT02258334's enrollment target sits among peer trials
208 399th of 2000 higher than 1,600 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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