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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00514033
First received: August 8, 2007
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention
Poliomyelitis
Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of unsolicited adverse events. [ Time Frame: During 7 days (Day 0 - 6) following vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: During the entire study period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local and general adverse events. [ Time Frame: During 7 days (Day 0 to 6) after vaccination ] [ Designated as safety issue: No ]

Enrollment: 349
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM
Deep intramuscular injections for the primary vaccination and booster vaccination.

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.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Korean children between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514033

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00514033     History of Changes
Other Study ID Numbers: 108344
Study First Received: August 8, 2007
Last Updated: March 15, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014