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NCT00601835 · ClinicalTrials.gov registry record · Phase 4
Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 3,651
- Enrollment target
NCT00601835: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00601835 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,651 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (605% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601835, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3,651 participants
- Enrollment target
Study Summary
To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age. To compare the post-vaccination geometric mean titers of antibody (GMTs) to Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the post-vaccination GMTs to the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age.
Primary Outcome
Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.
Interventions
- BIOLOGICAL Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,651 participants |
| Start Date | 2004-05 |
| Est. Completion | 2005-07 |
| Phase | Phase 4 |
What the finished NCT00601835 record still lists
NCT00601835 is an interventional study that assigns participants to a tested intervention. Its 3,651 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (605% higher).
The record links to 0 conditions, and to 1 intervention - of which Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine is the first listed.
NCT00601835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601835 about?
NCT00601835 is a clinical study titled "Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td". To compare the seroprotection rates and booster responses to Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine to the seroprotection rates and booster responses to the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine when administered to subjects ≥ 60 years of age....
What is the current status of trial NCT00601835?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,651 participants. The study started on 2004-05. Estimated completion is 2005-07.
What interventions are being tested in trial NCT00601835?
The interventions under investigation include: Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00601835?
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 NCT00601835's enrollment target sits among peer trials
3,651 22nd of 2000 higher than 1,979 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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