Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination
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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
GSK Investigational Site
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00610168
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
The formaldehyde-inactivated toxin of Corynebacterium diphtheriae. It is generally used in mixtures with TETANUS TOXOID and PERTUSSIS VACCINE; (DTP); or with tetanus toxoid alone (DT for pediatric use and Td, which contains 5- to 10-fold less diphtheria toxoid, for other use). Diphtheria toxoid is used for the prevention of diphtheria; DIPHTHERIA ANTITOXIN is for treatment.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
An antitoxin produced against the toxin of CORYNEBACTERIUM DIPHTHERIAE that is used for the treatment of DIPHTHERIA.
A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.
A localized infection of mucous membranes or skin caused by toxigenic strains of CORYNEBACTERIUM DIPHTHERIAE. It is characterized by the presence of a pseudomembrane at the site of infection. DIPHTHERIA TOXIN, produced by C. diphtheriae, can cause myocarditis, polyneuritis, and other systemic toxic effects.
Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outco...
This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals' Boostrix® vaccine in adults (extending indication) aged 65 years or older.
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The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity...
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa booster dose given 10 years after the previous vaccination with dTpa in study 263855/029. On...
Historically, diphtheria was a major cause of morbidity and mortality in the prevaccine era. However, in recent times there has been a resurgence of diphtheria, especially in the newly independent sta...
In the pre-vaccination era, diphtheria was a leading cause of childhood mortality. With the introduction of routine childhood immunization, paediatric care and improved hygiene status the disease has...
Demographic changes and a more active life-style in older age have contributed to an increasing public awareness of the need for lifelong vaccination. Currently many older persons have been vaccinated...
The need for boosters for tetanus, diphtheria, pertussis, and polio, starting from preschool age, is related to the waning immune protection conferred by vaccination, the elimination/reduction of natu...