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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: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00467519 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,045 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
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 |
What the finished NCT00467519 record still lists
NCT00467519 is an interventional study that assigns participants to a tested intervention. Its 1,045 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 (35% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00467519's enrollment target sits among peer trials
1,045 284th of 2000 higher than 1,717 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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