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

NCT00452686 | Completed Phase 3

• 1 other identifier: 108638
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria; Acellular Pertussis; Tetanus

Keywords

Chinese DT vaccin

Outcome Measures

Primary Outcomes (1)

• Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

Secondary Outcomes (1)

• Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

Interventions

Boostrix BIOLOGICAL

Chinese DT vaccine BIOLOGICAL

Also known as: Boostrix

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Suining, China

Location

Related 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):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.

  PMID: 20215881 BACKGROUND

Related 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.

MeSH Terms

Conditions

Diphtheria; Tetanus

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: March 1, 2007
• Study Completion: May 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)