NCT01988857

Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.

Detailed description

A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). This protocol summary was updated following an administrative change of adding the EudraCT number to this study.

Conditions

• Diphtheria
• Tetanus
• Acellular Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix™	Single-dose administered intramuscularly in the deltoid region of non-dominant arm.

Timeline

• Start date: 2014-02-22
• Primary completion: 2014-05-10
• Completion: 2014-05-10
• First posted: 2013-11-20
• Last updated: 2018-08-02
• Results posted: 2016-12-12

Locations

1 site across 1 country: Vietnam