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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
GSK Investigational Site
Suining, China

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Annotated Case Report Form 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 107924
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3). pii: 10503. Epub 2010 Mar 3.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00406562 History of Changes
Other Study ID Numbers:	107924
First Posted:	December 4, 2006
Last Update Posted:	October 27, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

uncontrolled

Additional relevant MeSH terms:

Diphtheria; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections