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NCT00802867 · ClinicalTrials.gov registry record · Phase 4

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

A Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
989
Enrollment target
19
Study locations

NCT00802867 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 989 participants, below the 1,801-participant average among 15 other Diphtheria trials with a reported enrollment target (45% lower). The trial reports 19 study locations across 14 states.

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The verdict

NCT00802867, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
989 participants
Enrollment target
19
Study locations

Study Summary

Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Conditions Studied

Diphtheria Tetanus Pertussis Polio Haemophilus Infection

Interventions

  • BIOLOGICAL Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

Study Locations (19)

Arkansas

  • - Jonesboro
  • - Little Rock

California

  • - Oakland
  • - Torrance

Massachusetts

  • - Boston
  • - Woburn

New York

  • - Albany
  • - Rochester

North Carolina

  • - Chapel Hill
  • - Sylva

Florida

  • - Orlando

Georgia

  • - Atlanta

Nebraska

  • - Omaha

Trial Details

FieldValue
Enrollment Target 989 participants
Start Date 2004-02
Est. Completion 2005-09
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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What the Registry Record Tells You About NCT00802867

The ClinicalTrials.gov registry entry for NCT00802867 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 989 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,801-participant average among 15 other Diphtheria trials with a reported enrollment target (45% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Diphtheria appearing as the primary indexed condition, and to 1 intervention - of which Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) is the first listed.

NCT00802867 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Arkansas, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00802867 about?

NCT00802867 is a clinical study titled "Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™". Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to childr...

What is the current status of trial NCT00802867?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 989 participants. The study started on 2004-02. Estimated completion is 2005-09.

What conditions does trial NCT00802867 study?

This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection.

What interventions are being tested in trial NCT00802867?

The interventions under investigation include: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00802867?

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

Where is trial NCT00802867 being conducted?

This trial has 19 study locations across Arkansas, California, Florida, Georgia, Massachusetts. 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.