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

Tetanus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406562
• Other study ID #: 107924
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2006
• Last updated: October 26, 2016
• Start date: January 2007
• Est. completion date: February 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• Boostrix

Locations

Country	Name	City	State
China	GSK Investigational Site	Suining

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

External Links

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