NCT00514033

A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 349 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Months – 6 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Poliomyelitis vaccine (inactivated) -PoliorixTM	Deep intramuscular injections for the primary vaccination and booster vaccination.

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-08-09
• Last updated: 2012-03-19

Locations

1 site across 1 country: South Korea