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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: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 989 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
What the finished NCT00802867 record still lists
NCT00802867 is an interventional study that assigns participants to a tested intervention. The registered 989 participants enrollment target is mid-sized for trials with a published cap, below the 1,801-participant average among 15 other Diphtheria trials with a reported enrollment target (45% lower).
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 lists 19 locations in 14 states (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.
Learn More About Clinical Trials
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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 NCT00802867's enrollment target sits among peer trials
989 9th of 15 higher than 7 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.
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