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NCT00662870 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
A Phase 3 study of Diphtheria and Tetanus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,941
- Enrollment target
- 20
- Study locations
NCT00662870: Completed Phase 3 study of Diphtheria and Tetanus, sponsored by Sanofi.
NCT00662870 is a Phase 3 study of Diphtheria and Tetanus that has completed, run by Sanofi. The registered enrollment target is 1,941 participants, above the 1,737-participant average among 15 other Diphtheria trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00662870, a Phase 3 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,941 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.
Conditions Studied
Interventions
- BIOLOGICAL DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
- BIOLOGICAL Pentacel: DTaP-IPV/Hib
Study Locations (20)
Arkansas
- - Fayetteville, AR 72703
- - Jonesboro, AR 72401
- - Little Rock, AR 72211
Pennsylvania
- - Norristown, PA 19401
- - Pittsburgh, PA 15213
- - Pittsburgh, PA 15241
California
- - Fountain Valley, CA 92708
Colorado
- - Englewood, CO 80112
Connecticut
- - Norwich, CT 06360
Florida
- - Orlando, FL 32856
Georgia
- - Marietta, GA 30062
Illinois
- - Chicago, IL 60614
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,941 participants |
| Start Date | 2001-05 |
| Est. Completion | 2004-01 |
| Phase | Phase 3 |
What the finished NCT00662870 record still lists
NCT00662870 is an interventional study that assigns participants to a tested intervention. Its 1,941 participants enrollment target places it among the larger protocols in the corpus, above the 1,737-participant average among 15 other Diphtheria trials with a reported enrollment target (12% higher).
The record links to 5 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) is the first listed.
NCT00662870 names 20 study sites across 16 states, led by Arkansas, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT00662870 about?
NCT00662870 is a clinical study titled "Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine". This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administere...
What is the current status of trial NCT00662870?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,941 participants. The study started on 2001-05. Estimated completion is 2004-01.
What conditions does trial NCT00662870 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Whooping Cough, Haemophilus Influenzae Type b, Polio.
What interventions are being tested in trial NCT00662870?
The interventions under investigation include: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) (BIOLOGICAL), Pentacel: DTaP-IPV/Hib (BIOLOGICAL).
Who is sponsoring clinical trial NCT00662870?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00662870 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00662870's enrollment target sits among peer trials
1,941 4th of 15 higher than 12 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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