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NCT00255047 · ClinicalTrials.gov registry record · Phase 3
Safety and Immune Response of Different Pediatric Combination Vaccines.
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,167
- Enrollment target
NCT00255047: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00255047 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,167 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (181% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00255047, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,167 participants
- Enrollment target
Study Summary
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Primary Outcome
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Interventions
- BIOLOGICAL DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
- BIOLOGICAL Pentacel®: DTaP-IPV/Hib combined
- BIOLOGICAL DTaP-IPV and ActHIB®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,167 participants |
| Start Date | 2005-11 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00255047 record still lists
NCT00255047 is an interventional study that assigns participants to a tested intervention. Its 2,167 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (181% higher).
The record links to 0 conditions, and to 3 interventions - of which DAPTACEL®. (DTaP), IPOL®., and ActHIB®. is the first listed.
NCT00255047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00255047 about?
NCT00255047 is a clinical study titled "Safety and Immune Response of Different Pediatric Combination Vaccines.". The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent ...
What is the current status of trial NCT00255047?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,167 participants. The study started on 2005-11. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00255047?
The interventions under investigation include: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. (BIOLOGICAL), Pentacel®: DTaP-IPV/Hib combined (BIOLOGICAL), DTaP-IPV and ActHIB® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00255047?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00255047's enrollment target sits among peer trials
2,167 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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