Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

GlaxoSmithKline660 enrolled

Overview

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

660

Conditions

Diphtheria Acellular Pertussis Tetanus

Interventions

BoostrixBIOLOGICAL

Chinese DT vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female between, and including, 6-8 years of age at the time of vaccination, * Written informed consent obtained from the parent or guardian of the subject, Exclusion Criteria: * Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate. * Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.

Locations (1)

GSK Investigational Site

Suining, China

Outcomes

Primary Outcomes

Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

Secondary Outcomes

Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

Data from ClinicalTrials.gov

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