Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®

NCT01277705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2016-09-07

No results posted yet for this study

Summary

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®

Conditions

  • Tetanus
  • Diphtheria
  • Acellular Pertussis

Interventions

BIOLOGICAL

GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine

Intramuscular, single

BIOLOGICAL

Boostrix™

Intramuscular, single dose

BIOLOGICAL

GSK Biologicals' IPV vaccine

Intramuscular, single dose

BIOLOGICAL

Revaxis®

Intramuscular, single dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2002-04-30
Completion
2002-04-30

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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 NCT01277705 on ClinicalTrials.gov