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NCT00319553 · ClinicalTrials.gov registry record · Phase 4
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
A Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 647
- Enrollment target
- 10
- Study locations
NCT00319553: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi.
NCT00319553 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi. The registered enrollment target is 647 participants, below the 1,824-participant average among 15 other Diphtheria trials with a reported enrollment target (65% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319553, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 647 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Primary Outcome
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Conditions Studied
Interventions
- BIOLOGICAL ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
- BIOLOGICAL BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Study Locations (10)
Washington
- - Bellevue
- - Mercer Island
- - Sammamish
- - Seattle
Maryland
- - Annapolis
- - Baltimore
- - Frederick
North Carolina
- - Durham
- - Durham
Tennessee
- - Franklin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00319553 record still lists
NCT00319553 is an interventional study that assigns participants to a tested intervention. The registered 647 participants enrollment target is mid-sized for trials with a published cap, below the 1,824-participant average among 15 other Diphtheria trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed is the first listed.
NCT00319553 lists 10 locations in 4 states (Washington, Maryland, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00319553 about?
NCT00319553 is a clinical study titled "Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®". This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
What is the current status of trial NCT00319553?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 647 participants. The study started on 2006-05. Estimated completion is 2008-12.
What conditions does trial NCT00319553 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis.
What interventions are being tested in trial NCT00319553?
The interventions under investigation include: ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed (BIOLOGICAL), BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT00319553?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00319553 being conducted?
This trial has 10 study locations across Maryland, North Carolina, Tennessee, Washington. 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 NCT00319553's enrollment target sits among peer trials
647 10th of 15 higher than 6 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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