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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 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 649 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00258895
The ClinicalTrials.gov registry entry for NCT00258895 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 649 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DAPTACEL®: DTaP is the first listed.
NCT00258895 reports 0 study locations.
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.
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