Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

NCT01262924 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2010-12-17

No results posted yet for this study

Summary

The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™

Conditions

  • Diphteria, Tetanus and Pertussis

Interventions

BIOLOGICAL

GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine

Intramuscular, single dose

BIOLOGICAL

GSK Biologicals' reduced-antigen-content acellular pertussis vaccine

Intramuscular, single dose

BIOLOGICAL

Tedivax-Adult™/ Td-Rix™

Intramuscular, single dose or 2 doses (in the annex phase)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-10-31
Primary Completion
1998-12-31
Completion
1998-12-31

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Entities

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 NCT01262924 on ClinicalTrials.gov