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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination

03:22 EDT 22nd July 2014 | BioPortfolio

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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.

Description

This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Diphtheria

Intervention

Boostrix TM

Location

GSK Investigational Site
Turku
Finland
20520

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Clinical Trials [78 Associated Clinical Trials listed on BioPortfolio]

Post-Marketing Safety Study of GSK Biologicals' Boostrix® Vaccine.

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...

Evaluation of GSK Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.

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.

Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.

Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

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...

Evaluation of Boostrix™10 Years After Previous Booster Vaccination

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...

PubMed Articles [49 Associated PubMed Articles listed on BioPortfolio]

Neurologic manifestations of diphtheria and pertussis.

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...

Diphtheria Re-emergence: Problems Faced by Developing Countries.

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...

Assessment of Immune Response following Immunization with DTP/Td and MMR Vaccines in Children Treated for Acute Lymphoblastic Leukemia.

Background: This study was performed to determine the antibody titers against diphtheria-tetanus-pertussis, and measles-mumps-rubella before and after re-vaccination in different periods of time in pa...

A Randomized Study to Evaluate the Immunogenicity and Safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus influenzae b, and Meningococcal Serogroup C Combination Vaccine Administered to Infants at 2, 4, and 12 Months of Age.

The immunogenicity and safety of the investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib), and meningococcal serogroup C (MenC) hep...

Isolated eccentric lingual diphtheria: A relevance.

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.

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