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

GlaxoSmithKline349 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

349

Conditions

Poliomyelitis

Interventions

Poliomyelitis vaccine (inactivated) -PoliorixTMBIOLOGICAL

Deep intramuscular injections for the primary vaccination and booster vaccination.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Occurrence of solicited local and general adverse events.

Time frame: During 7 days (Day 0 to 6) after vaccination

Data from ClinicalTrials.gov

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