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NCT00467519 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,045
- Enrollment target
NCT00467519 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,045 participants.
The verdict
NCT00467519, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,045 participants
- Enrollment target
Study Summary
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Primary Objective: \- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. Secondary/Observational Objectives: * To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. * To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up. * To describe the safety profile following vaccine administration.
Interventions
- BIOLOGICAL Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
- BIOLOGICAL DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,045 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00467519
The ClinicalTrials.gov registry entry for NCT00467519 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,045 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 2 interventions - of which Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) is the first listed.
NCT00467519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00467519 about?
NCT00467519 is a clinical study titled "Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age". Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Primary Objective: \- To compare the immune respons...
What is the current status of trial NCT00467519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,045 participants. The study started on 2007-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00467519?
The interventions under investigation include: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) (BIOLOGICAL), DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00467519?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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