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NCT00988143 · ClinicalTrials.gov registry record · Phase 2

A Study of Influenza Virus Vaccines in Children and Adults

A Phase 2 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
600
Enrollment target
4
Study locations

NCT00988143 is a Phase 2 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 600 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT00988143, a Phase 2 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
600 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives: * To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age. * To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL 2009-2010 Trivalent Influenza Virus Vaccine
  • BIOLOGICAL 2008-2009 Trivalent Influenza Virus Vaccine
  • BIOLOGICAL Quadrivalent Influenza Virus Vaccine

Study Locations (4)

North Carolina

  • - Durham

Ohio

  • - Cincinnati

Pennsylvania

  • - Jefferson Hills

Virginia

  • - Norfolk

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2009-10
Est. Completion 2010-03
Phase Phase 2

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00988143

The ClinicalTrials.gov registry entry for NCT00988143 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% 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 2009-2010 Trivalent Influenza Virus Vaccine is the first listed.

NCT00988143 reports 4 study locations spanning 4 distinct geographic areas - top geographies include North Carolina, Ohio, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00988143 about?

NCT00988143 is a clinical study titled "A Study of Influenza Virus Vaccines in Children and Adults". The purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadri...

What is the current status of trial NCT00988143?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2009-10. Estimated completion is 2010-03.

What conditions does trial NCT00988143 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00988143?

The interventions under investigation include: 2009-2010 Trivalent Influenza Virus Vaccine (BIOLOGICAL), 2008-2009 Trivalent Influenza Virus Vaccine (BIOLOGICAL), Quadrivalent Influenza Virus Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00988143?

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

Where is trial NCT00988143 being conducted?

This trial has 4 study locations across North Carolina, Ohio, Pennsylvania, Virginia. 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.