A Post-Marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00514033

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

MedlinePlus related topics: Polio and Post-Polio Syndrome

Drug Information available for: Poliovirus Vaccines

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Multicentric, PMS Study to Monitor Safety & Reactogenicity of GSK Biologicals' IPV Vaccine (Poliorix) Administered in Healthy Korean Children as Primary Vaccination at 2 to 6 Months of Age or as a Booster Vaccination at 4 to 6 Years of Age

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: Yes ]
Occurrence of serious adverse events (SAEs). [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

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: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	July 2007
Estimated Primary Completion Date:	January 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

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

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Locations

Korea, Republic of
GSK Investigational Site	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	108344
Study First Received:	August 8, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00514033
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Spinal Cord Diseases
Picornaviridae Infections
Central Nervous System Diseases
Healthy
Degenerative motor system disease
Motor neuron disease
Virus Diseases

Central Nervous System Infections
Neuromuscular Diseases
Poliomyelitis
Myelitis
Enterovirus Infections
Motor Neuron Disease

Additional relevant MeSH terms:

RNA Virus Infections
Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on January 16, 2009