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NCT02563093 · ClinicalTrials.gov registry record · Phase 4

Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
208
Enrollment target
4
Study locations

NCT02563093 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 208 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT02563093, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
208 participants
Enrollment target
4
Study locations

Study Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: \- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2015-2016 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 Quadrivalent, 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) Committee for Propriety Medicinal Products (CPMP) - CHMP NfG CPMP/BWP/214/96.

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
  • BIOLOGICAL Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
  • BIOLOGICAL Fluzone High-Dose vaccine, 2015-2016 formulation

Study Locations (4)

California

  • - Santa Rosa

Iowa

  • - Council Bluffs

Louisiana

  • - Metairie

Ohio

  • - Cincinnati

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2015-09
Est. Completion 2016-07
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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What the Registry Record Tells You About NCT02563093

The ClinicalTrials.gov registry entry for NCT02563093 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, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative is the first listed.

NCT02563093 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Iowa, Louisiana.

Frequently Asked Questions

What is clinical trial NCT02563093 about?

NCT02563093 is a clinical study titled "Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults". The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults...

What is the current status of trial NCT02563093?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2015-09. Estimated completion is 2016-07.

What conditions does trial NCT02563093 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT02563093?

The interventions under investigation include: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative (BIOLOGICAL), Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation (BIOLOGICAL), Fluzone High-Dose vaccine, 2015-2016 formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT02563093?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02563093 being conducted?

This trial has 4 study locations across California, Iowa, Louisiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.