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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00406562

Purpose

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.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis	Biological: Boostrix	Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

Estimated Enrollment:	30
Study Start Date:	January 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,
Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,

Exclusion Criteria:

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: NCT00406562

Locations

China
GSK Investigational Site
Suining, China

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107924
Study First Received:	December 1, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00406562
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

uncontrolled

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
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009