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NCT01430819 · ClinicalTrials.gov registry record · Phase 4

Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

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

Completed
Registry status
Phase 4
Development phase
300
Enrollment target
6
Study locations

NCT01430819 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 300 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT01430819, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
300 participants
Enrollment target
6
Study locations

Study Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
  • BIOLOGICAL Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation

Study Locations (6)

Colorado

  • - Colorado Springs

Iowa

  • - Council Buffs

Louisiana

  • - Metairie

Missouri

  • - Springfield

Pennsylvania

  • - Bensalem

Texas

  • - Austin

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2011-09
Est. Completion 2012-02
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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What the Registry Record Tells You About NCT01430819

The ClinicalTrials.gov registry entry for NCT01430819 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,802-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 2 interventions - of which Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation is the first listed.

NCT01430819 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Colorado, Iowa, Louisiana.

Frequently Asked Questions

What is clinical trial NCT01430819 about?

NCT01430819 is a clinical study titled "Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults". The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older. Objectives: * To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age. * ...

What is the current status of trial NCT01430819?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2011-09. Estimated completion is 2012-02.

What conditions does trial NCT01430819 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT01430819?

The interventions under investigation include: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation (BIOLOGICAL), Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT01430819?

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

Where is trial NCT01430819 being conducted?

This trial has 6 study locations across Colorado, Iowa, Louisiana, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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