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

NCT00835237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1332

Last updated 2020-01-03

Study results available
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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

  • Tetanus
  • Acellular Pertussis
  • Diphtheria
  • Diphtheria-Tetanus-acellular Pertussis Vaccines

Interventions

BIOLOGICAL

Boostrix®

Intramuscular, single dose.

BIOLOGICAL

Decavac™

Intramuscular, single dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-17
Primary Completion
2009-07-23
Completion
2009-10-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00835237 on ClinicalTrials.gov