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OpenTrials
Completed

NCT Number: NCT00514033

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

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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Key information

Conditions

Poliomyelitis Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

2 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poliomyelitis vaccine (inactivated) -PoliorixTM

Biological

Deep intramuscular injections for the primary vaccination and booster vaccination.

Primary outcomes

  1. Occurrence of unsolicited adverse events.

    Time frame: During 7 days (Day 0 - 6) following vaccination.

  2. Occurrence of serious adverse events (SAEs).

    Time frame: During the entire study period.

Secondary outcomes

  1. Occurrence of solicited local and general adverse events.

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 9, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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