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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 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,330 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01439165
The ClinicalTrials.gov registry entry for NCT01439165 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,330 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 Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine is the first listed.
NCT01439165 reports 0 study locations.
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.
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