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NCT01629589 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
A Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 423
- Enrollment target
- 8
- Study locations
NCT01629589 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 423 participants, below the 1,839-participant average among 15 other Diphtheria trials with a reported enrollment target (77% lower). The trial reports 8 study locations across 8 states.
The verdict
NCT01629589, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 423 participants
- Enrollment target
- 8
- Study locations
Study Summary
The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to \<13 years of age. Primary objective: * To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. Observational objectives: * To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Conditions Studied
Interventions
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)
Study Locations (8)
California
- - Sacramento
Kentucky
- - Bardstown
Massachusetts
- - Woburn
Ohio
- - Cleveland
South Carolina
- - Barnwell
Tennessee
- - Kingsport
Utah
- - Salt Lake City
Virginia
- - Vienna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01629589
The ClinicalTrials.gov registry entry for NCT01629589 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,839-participant average among 15 other Diphtheria trials with a reported enrollment target (77% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) is the first listed.
NCT01629589 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Kentucky, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01629589 about?
NCT01629589 is a clinical study titled "Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents". The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to \<13 years of age. Primary objective: * To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive...
What is the current status of trial NCT01629589?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 423 participants. The study started on 2012-06. Estimated completion is 2013-06.
What conditions does trial NCT01629589 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis, Whooping Cough.
What interventions are being tested in trial NCT01629589?
The interventions under investigation include: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) (BIOLOGICAL), Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01629589?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01629589 being conducted?
This trial has 8 study locations across California, Kentucky, Massachusetts, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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