A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Open, Multicentric, PMS Study to Monitor Safety and Reactogenicity of GlaxoSmithKline Biologicals' Poliomyelitis Vaccine (Inactivated)-Poliorix, Administered in Korean Children as a Primary Vaccination in Healthy Subjects Aged 2 to 6 Months or as a Booster Vaccination in Subjects Aged 4 to 6 Years|
- Occurrence of unsolicited adverse events. [ Time Frame: During 7 days (Day 0 - 6) following vaccination. ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events (SAEs). [ Time Frame: During the entire study period. ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general adverse events. [ Time Frame: During 7 days (Day 0 to 6) after vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
PoliorixTM will be administered according to a 3-dose schedule at 2, 4, 6 months for primary vaccination followed by a booster dose between 4 to 6 years. For the primary vaccination course, 1 to 3 doses of the vaccine will be given depending on previous vaccination history with poliomyelitis vaccine.
Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM
Deep intramuscular injections for the primary vaccination and booster vaccination.
An open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals. Poliomyelitis vaccine (inactivated) -PoliorixTM., administered in Korean children as a primary vaccination in healthy subjects aged two to six months or as a booster vaccination in subjects aged four to six years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514033
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|