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
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
- lead INDUSTRY
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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