Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL

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
GlaxoSmithKline

1,345 total trials

What the finished NCT00835237 record still lists

NCT00835237 is an interventional study that assigns participants to a tested intervention. Its 1,332 participants enrollment target places it among the larger protocols in the corpus, below the 1,778-participant average among 15 other Diphtheria trials with a reported enrollment target (25% lower).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Diphtheria

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 NCT00835237's enrollment target sits among peer trials

1,332 7th of 15 higher than 9 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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05415761 · 1,332 participants · NA

    Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

  • NCT05511298 · 1,332 participants

    Empowering Students Project

  • NCT06934876 · 1,332 participants

    Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

  • NCT06972056 · 1,335 participants · Phase 4

    Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT00835237, the US trial registry maintained by the National Library of Medicine. NCT00835237 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.