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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

349 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-07-31

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).

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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.

Conditions

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Poliomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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.

Poliomyelitis vaccine (inactivated) -PoliorixTM

Intervention Type BIOLOGICAL

Deep intramuscular injections for the primary vaccination and booster vaccination.

Interventions

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Poliomyelitis vaccine (inactivated) -PoliorixTM

Deep intramuscular injections for the primary vaccination and booster vaccination.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes