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+HibTM 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 Diseases
|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|
- Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: From the booster dose (Day 0) up to study end (Month 1) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Infanrix-IPV+Hib Group
Children will receive a single dose of Infanrix-IPV+Hib at 12-24 months of age.
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.