Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children|
- Occurrence of each solicited local symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
- Occurrence of each solicited general symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination. ] [ Designated as safety issue: No ]
- Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Day 0 up to study end (Day 30). ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: dTpa Group
Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988857
|GSK Investigational Site|
|Hanoi, Vietnam, 084|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|