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NCT00347958 · ClinicalTrials.gov registry record · Phase 4

Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine

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

Completed
Registry status
Phase 4
Development phase
545
Enrollment target
10
Study locations

NCT00347958 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 545 participants, below the 1,830-participant average among 15 other Diphtheria trials with a reported enrollment target (70% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT00347958, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
545 participants
Enrollment target
10
Study locations

Study Summary

Objectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

Interventions

  • BIOLOGICAL Tetanus-diphtheria-acellular pertussis (Tdap) vaccine

Study Locations (10)

British Columbia

  • - Coquitlam
  • - Surrey

Quebec

  • - Beauport
  • - Montreal

Arkansas

  • - Jonesboro

Louisiana

  • - Bossier City

Ohio

  • - University Heights

Pennsylvania

  • - Pittsburgh

Manitoba

  • - Winnipeg

Nova Scotia

  • - Halifax

Trial Details

FieldValue
Enrollment Target 545 participants
Start Date 2006-08
Est. Completion 2008-10
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT00347958

The ClinicalTrials.gov registry entry for NCT00347958 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 545 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,830-participant average among 15 other Diphtheria trials with a reported enrollment target (70% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 1 intervention - of which Tetanus-diphtheria-acellular pertussis (Tdap) vaccine is the first listed.

NCT00347958 reports 10 study locations spanning 8 distinct geographic areas - top geographies include British Columbia, Quebec, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00347958 about?

NCT00347958 is a clinical study titled "Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine". Objectives: To provide safety data on revaccination with ADACEL® vaccine. To describe the immune response to tetanus, diphtheria, and pertussis antigens following revaccination with ADACEL® vaccine 4-5 years after first vaccination.

What is the current status of trial NCT00347958?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 545 participants. The study started on 2006-08. Estimated completion is 2008-10.

What conditions does trial NCT00347958 study?

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

What interventions are being tested in trial NCT00347958?

The interventions under investigation include: Tetanus-diphtheria-acellular pertussis (Tdap) vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00347958?

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

Where is trial NCT00347958 being conducted?

This trial has 10 study locations across Arkansas, Louisiana, Ohio, Pennsylvania, British Columbia. 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.