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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00514033

Enrollment

349

Registered

2007-08-09

Start date

2007-07-31

Completion date

2011-07-31

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poliomyelitis

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.

Interventions

BIOLOGICALPoliomyelitis vaccine (inactivated) -PoliorixTM

Deep intramuscular injections for the primary vaccination and booster vaccination.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026