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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00319553
The ClinicalTrials.gov registry entry for NCT00319553 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 647 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,824-participant average among 15 other Diphtheria trials with a reported enrollment target (65% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.