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A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years
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™
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 116 |
| Start date | 1997-10 |
| Completion | 1998-12 |
Conditions
- Diphteria, Tetanus and Pertussis
Interventions
- GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
- GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
- Tedivax-Adult™/ Td-Rix™
Primary outcomes
- Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) — One month after the booster dose (Month 1)