Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452686
• Other study ID #: 108638
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2007
• Last updated: October 27, 2016
• Start date: March 2007
• Est. completion date: May 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 immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: May 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,

Exclusion Criteria:

• Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• Boostrix

• Chinese DT vaccine

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	Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary	Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

External Links

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