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NCT00282295 · ClinicalTrials.gov registry record · Phase 4
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
A Phase 4 study of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,344
- Enrollment target
- 20
- Study locations
NCT00282295: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.
NCT00282295 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,344 participants, below the 1,777-participant average among 15 other Diphtheria trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00282295, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,344 participants
- Enrollment target
- 20
- Study locations
Study Summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
Primary Outcome
Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Conditions Studied
Interventions
- BIOLOGICAL Boostrix®
- BIOLOGICAL Menactra™
Study Locations (20)
Pennsylvania
- GSK Investigational Site - Erie
- GSK Investigational Site - Erie
- GSK Investigational Site - Greenville
- GSK Investigational Site - Philadelphia
- GSK Investigational Site - Pittsburgh
- GSK Investigational Site - Pittsburgh
Maryland
- GSK Investigational Site - Annapolis
- GSK Investigational Site - Frederick
New York
- GSK Investigational Site - Pittsford
- GSK Investigational Site - Rochester
Ohio
- GSK Investigational Site - Akron
- GSK Investigational Site - University Heights
Arizona
- GSK Investigational Site - Chandler
Arkansas
- GSK Investigational Site - Little Rock
California
- GSK Investigational Site - Fountain Valley
Colorado
- GSK Investigational Site - Golden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,344 participants |
| Start Date | 2006-01-25 |
| Est. Completion | 2006-08-08 |
| Phase | Phase 4 |
What the finished NCT00282295 record still lists
NCT00282295 is an interventional study that assigns participants to a tested intervention. Its 1,344 participants enrollment target places it among the larger protocols in the corpus, below the 1,777-participant average among 15 other Diphtheria trials with a reported enrollment target (24% lower).
The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which Boostrix® is the first listed.
NCT00282295 names 20 study sites across 12 states, led by Pennsylvania, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT00282295 about?
NCT00282295 is a clinical study titled "US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease". New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular ...
What is the current status of trial NCT00282295?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,344 participants. The study started on 2006-01-25. Estimated completion is 2006-08-08.
What conditions does trial NCT00282295 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Acellular Pertussis.
What interventions are being tested in trial NCT00282295?
The interventions under investigation include: Boostrix® (BIOLOGICAL), Menactra™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00282295?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00282295 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Georgia. 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 NCT00282295's enrollment target sits among peer trials
1,344 6th of 15 higher than 10 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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