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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 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 208 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02258334
The ClinicalTrials.gov registry entry for NCT02258334 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 208 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, 2014-2015 formulation is the first listed.
NCT02258334 reports 0 study locations.
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.
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