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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: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2006-08 |
| Est. Completion | 2008-10 |
| Phase | Phase 4 |
What the finished NCT00347958 record still lists
NCT00347958 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, below the 1,830-participant average among 15 other Diphtheria trials with a reported enrollment target (70% lower).
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 lists 10 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Diphtheria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00347958's enrollment target sits among peer trials
545 11th of 15 higher than 5 of 15 other Diphtheria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diphtheria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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