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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 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.

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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.

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

FieldValue
Enrollment Target 1,344 participants
Start Date 2006-01-25
Est. Completion 2006-08-08
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00282295

The ClinicalTrials.gov registry entry for NCT00282295 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,344 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,777-participant average among 15 other Diphtheria trials with a reported enrollment target (24% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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