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NCT00835237 · ClinicalTrials.gov registry record · Phase 3

Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

A Phase 3 study of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,332
Enrollment target
20
Study locations

NCT00835237 is a Phase 3 study of Diphtheria and Tetanus that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,332 participants, below the 1,778-participant average among 15 other Diphtheria trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00835237, a Phase 3 study of Diphtheria and Tetanus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,332 participants
Enrollment target
20
Study locations

Study Summary

This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.

Conditions Studied

Diphtheria Tetanus Acellular Pertussis Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

  • BIOLOGICAL Boostrix®
  • BIOLOGICAL Decavac™

Study Locations (20)

Ohio

  • GSK Investigational Site - Cleveland
  • GSK Investigational Site - Mogadore
  • GSK Investigational Site - Wadsworth

Florida

  • GSK Investigational Site - DeLand
  • GSK Investigational Site - West Palm Beach

Maryland

  • GSK Investigational Site - Columbia
  • GSK Investigational Site - Elkridge

North Carolina

  • GSK Investigational Site - High Point
  • GSK Investigational Site - Wilmington

Arizona

  • GSK Investigational Site - Tucson

California

  • GSK Investigational Site - Los Angeles

Georgia

  • GSK Investigational Site - Stockbridge

Indiana

  • GSK Investigational Site - Indianapolis

Trial Details

FieldValue
Enrollment Target 1,332 participants
Start Date 2009-02-17
Est. Completion 2009-10-15
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00835237

The ClinicalTrials.gov registry entry for NCT00835237 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,332 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,778-participant average among 15 other Diphtheria trials with a reported enrollment target (25% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 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 Boostrix® is the first listed.

NCT00835237 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Ohio, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT00835237 about?

NCT00835237 is a clinical study titled "Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.". This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.

What is the current status of trial NCT00835237?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,332 participants. The study started on 2009-02-17. Estimated completion is 2009-10-15.

What conditions does trial NCT00835237 study?

This clinical trial studies the following conditions: Diphtheria, Tetanus, Acellular Pertussis, Diphtheria-Tetanus-acellular Pertussis Vaccines.

What interventions are being tested in trial NCT00835237?

The interventions under investigation include: Boostrix® (BIOLOGICAL), Decavac™ (BIOLOGICAL).

Who is sponsoring clinical trial NCT00835237?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00835237 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.