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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
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
Biological: Boostrix
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00406562

GSK Investigational Site
Suining, China
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00406562     History of Changes
Other Study ID Numbers: 107924 
Study First Received: December 1, 2006
Last Updated: September 29, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on October 21, 2016