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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 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,167 participants.
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®.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00255047
The ClinicalTrials.gov registry entry for NCT00255047 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,167 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 3 interventions - of which DAPTACEL®. (DTaP), IPOL®., and ActHIB®. is the first listed.
NCT00255047 reports 0 study locations.
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.
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