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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452686

Enrollment

660

Registered

2007-03-27

Start date

2007-03-31

Completion date

2007-05-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Acellular Pertussis, Tetanus

Keywords

Chinese DT vaccin

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.

Interventions

BIOLOGICALBoostrix

BIOLOGICALChinese DT vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 8 Years

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,

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.

Design outcomes

Primary

Measure	Time frame
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.	—

Secondary

Measure	Time frame
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026