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NCT01439165 · ClinicalTrials.gov registry record · Phase 4
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,330
- Enrollment target
NCT01439165: Completed Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01439165 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,330 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439165, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,330 participants
- Enrollment target
Study Summary
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier. Primary Objectives: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants. Secondary Objectives: * To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine. * To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine.
Primary Outcome
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.
Interventions
- BIOLOGICAL Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine
- BIOLOGICAL Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,330 participants |
| Start Date | 2011-11 |
| Est. Completion | 2017-02 |
| Phase | Phase 4 |
What the finished NCT01439165 record still lists
NCT01439165 is an interventional study that assigns participants to a tested intervention. Its 1,330 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 (157% higher).
The record links to 0 conditions, and to 2 interventions - of which Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine is the first listed.
NCT01439165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439165 about?
NCT01439165 is a clinical study titled "Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose". The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial va...
What is the current status of trial NCT01439165?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,330 participants. The study started on 2011-11. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01439165?
The interventions under investigation include: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine (BIOLOGICAL), Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (BIOLOGICAL).
Who is sponsoring clinical trial NCT01439165?
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 NCT01439165's enrollment target sits among peer trials
1,330 58th of 2000 higher than 1,943 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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