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

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ClinicalTrials.gov Identifier: NCT00406562

Recruitment Status : Completed

First Posted : December 4, 2006

Last Update Posted : October 27, 2016

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tetanus Diphtheria Acellular Pertussis	Biological: Boostrix	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Study Start Date :	January 2007
Actual Study Completion Date :	February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus, Diphtheria, and Pertussis Vaccines

Drug Information available for: Boostrix Diphtheria-Tetanus-acellular Pertussis Vaccines

Genetic and Rare Diseases Information Center resources: Tetanus Diphtheria Whooping Cough

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 8 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406562

Locations


China
GSK Investigational Site
Suining, China

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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