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

This study has been completed.

First Received: March 26, 2007 Last Updated: January 22, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00452686

Purpose

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.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis	Biological: Boostrix Biological: Chinese DT vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Drug Information available for: Diphtheria-Tetanus Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	660
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	6 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452686

Locations

China
GSK Investigational Site
Suining, China

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108638
Study First Received:	March 26, 2007
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00452686 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Chinese DT vaccin

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough

Whooping Cough
Healthy
Diphtheria
Tetanus
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Bordetella Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections

Whooping Cough
Diphtheria
Infection
Actinomycetales Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 10, 2009