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NCT00258895 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 649
- Enrollment target
NCT00258895: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00258895 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 649 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258895, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 649 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. Observational Objectives: 1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates. 3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.
Interventions
- BIOLOGICAL DAPTACEL®: DTaP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 649 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00258895 record still lists
NCT00258895 is an interventional study that assigns participants to a tested intervention. The registered 649 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 1 intervention - of which DAPTACEL®: DTaP is the first listed.
NCT00258895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00258895 about?
NCT00258895 is a clinical study titled "Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®". Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of...
What is the current status of trial NCT00258895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 649 participants. The study started on 2005-03. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00258895?
The interventions under investigation include: DAPTACEL®: DTaP (BIOLOGICAL).
Who is sponsoring clinical trial NCT00258895?
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 NCT00258895's enrollment target sits among peer trials
649 572nd of 2000 higher than 1,429 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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