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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.

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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

FieldValue
Enrollment Target 208 participants
Start Date 2014-10
Est. Completion 2014-12
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.