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

Completed

• Conditions: Poliomyelitis
• Interventions: Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM

• Registration Number: NCT00514033
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)
• Written informed consent obtained from the parent/ guardian of the subject

Exclusion Criteria

• At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Poliomyelitis vaccine (inactivated) -PoliorixTM	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of unsolicited adverse events.	During 7 days (Day 0 - 6) following vaccination.
Occurrence of serious adverse events (SAEs).	During the entire study period.

Secondary Outcome Measures

Name	Time	Method
Occurrence of solicited local and general adverse events.	During 7 days (Day 0 to 6) after vaccination

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of