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

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ClinicalTrials.gov Identifier: NCT00514033
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment
Poliomyelitis Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM

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.

Study Type : Observational
Actual Enrollment : 349 participants
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
Study Start Date : July 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Occurrence of solicited local and general adverse events. [ Time Frame: During 7 days (Day 0 to 6) after vaccination ]


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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514033


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00514033     History of Changes
Other Study ID Numbers: 108344
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs