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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.
Information provided by:
GlaxoSmithKline Identifier:
First received: December 1, 2006
Last updated: September 29, 2011
Last verified: September 2011

December 1, 2006
September 29, 2011
January 2007
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Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
Same as current
Complete list of historical versions of study NCT00406562 on Archive Site
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Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.
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.
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.
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Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Pertussis
  • Tetanus
Biological: Boostrix
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
6 Years to 8 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
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Study Director: GSK Clinical Trials GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP