Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
NCT00548171 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2020-01-13
Summary
The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
No new recruitment will be performed in this booster phase (see inclusion criteria).
Conditions
- Acellular Pertussis
- Tetanus
- Diphtheria
- Diphtheria-Tetanus-acellular Pertussis Vaccines
Interventions
- BIOLOGICAL
-
Boostrix™
Intramuscular injection, 1 dose
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 28 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-11-05
- Primary Completion
- 2008-04-30
- Completion
- 2008-04-30
Countries
- Australia
Study Locations
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