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
Intervention Details:
    Biological: Boostrix
    Other Name: Boostrix

Ages Eligible for Study:   6 Years to 8 Years
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
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

No publications provided

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:
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections processed this record on April 17, 2014