Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
|Study Design:||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|
- Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ]Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ]Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
- Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within 31 days (Days 0-30) post vaccination period ]An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (From Day 0 to Day 30) ]Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|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|