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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406562

Enrollment

Registered

2006-12-04

Start date

2007-01-31

Completion date

2007-02-28

Last updated

2016-10-27

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

Conditions

Tetanus, Diphtheria, Acellular Pertussis

Keywords

uncontrolled

Brief 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.

Interventions

BIOLOGICALBoostrix

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

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, * 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

Design outcomes

Primary

Measure	Time frame
Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events	—

Countries

China

Outcome results

None listed

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