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NCT00391391 · ClinicalTrials.gov registry record · Phase 2

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

A Phase 2 study of Influenza and Orthomyxoviridae Infection, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
520
Enrollment target
19
Study locations

NCT00391391 is a Phase 2 study of Influenza and Orthomyxoviridae Infection that has completed, run by Sanofi. The registered enrollment target is 520 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 9 states.

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The verdict

NCT00391391, a Phase 2 study of Influenza and Orthomyxoviridae Infection, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
520 participants
Enrollment target
19
Study locations

Study Summary

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Conditions Studied

Influenza Orthomyxoviridae Infection Myxovirus Infection

Interventions

  • BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine
  • BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Study Locations (19)

California

  • - Bellflower
  • - Downey
  • - Fountain Valley
  • - Paramount

Pennsylvania

  • - Erie
  • - Pittsburgh
  • - Uniontown
  • - Wexford

Arkansas

  • - Harrisburg
  • - Little Rock
  • - Trumann

Louisiana

  • - Bossier City
  • - Shreveport

Utah

  • - Salt Lake City
  • - Salt Lake City

Kentucky

  • - Owensboro

Minnesota

  • - Brainerd

Ohio

  • - Cleveland

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2006-10
Est. Completion 2007-10
Phase Phase 2

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00391391

The ClinicalTrials.gov registry entry for NCT00391391 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Split, Inactivated, Trivalent Influenza Vaccine is the first listed.

NCT00391391 reports 19 study locations spanning 9 distinct geographic areas - top geographies include California, Pennsylvania, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00391391 about?

NCT00391391 is a clinical study titled "Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children". Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to...

What is the current status of trial NCT00391391?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 520 participants. The study started on 2006-10. Estimated completion is 2007-10.

What conditions does trial NCT00391391 study?

This clinical trial studies the following conditions: Influenza, Orthomyxoviridae Infection, Myxovirus Infection.

What interventions are being tested in trial NCT00391391?

The interventions under investigation include: Split, Inactivated, Trivalent Influenza Vaccine (BIOLOGICAL), Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00391391?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00391391 being conducted?

This trial has 19 study locations across Arkansas, California, Kentucky, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.