An observational study in Poliomyelitis, sponsored by GlaxoSmithKline. Completed at 1 site in South Korea. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by GlaxoSmithKline · Observational
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).
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.
227 studies on the registry are indexed under Poliomyelitis; 12 are open to participants now.
This study's enrollment of 349 is below the median of 405 across 20 observational studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Korean children between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
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Exclusion Criteria:
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.
Occurrence of unsolicited adverse events.
Time frame: During 7 days (Day 0 - 6) following vaccination.
Occurrence of serious adverse events (SAEs).
Time frame: During the entire study period.
Occurrence of solicited local and general adverse events.
Time frame: During 7 days (Day 0 to 6) after vaccination
The record gives a start of Jul 2007, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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