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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: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL
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 |
What the finished NCT01629589 record still lists
NCT01629589 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, below the 1,839-participant average among 15 other Diphtheria trials with a reported enrollment target (77% lower).
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01629589's enrollment target sits among peer trials
423 12th of 15 higher than 4 of 15 other Diphtheria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diphtheria 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.
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