Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.
Haemophilus Influenzae Type b
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers|
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ] [ Designated as safety issue: No ]Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ] [ Designated as safety issue: No ]Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination. ] [ Designated as safety issue: No ]An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
- Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-30). ] [ Designated as safety issue: No ]SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
|Study Start Date:||December 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Infanrix-IPV+Hib Group
Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577732
|GSK Investigational Site|
|Hai Phong, Vietnam|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|