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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>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<br>* Deep intramuscular injections for the primary vaccination and booster vaccination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited local and general adverse events. |  | During 7 days (Day 0 to 6) after vaccination |