Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-13 @ 5:57 PM
Study NCT ID:
NCT00514033
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2007-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023321', 'term': 'Poliovirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2007-08-08', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of unsolicited adverse events.', 'timeFrame': 'During 7 days (Day 0 - 6) following vaccination.'}, {'measure': 'Occurrence of serious adverse events (SAEs).', 'timeFrame': 'During the entire study period.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of solicited local and general adverse events.', 'timeFrame': 'During 7 days (Day 0 to 6) after vaccination'}]}, 'conditionsModule': {'conditions': ['Poliomyelitis']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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)\n* Written informed consent obtained from the parent/ guardian of the subject\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT00514033', 'briefTitle': 'A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '108344'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': '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.', 'interventionNames': ['Biological: Poliomyelitis vaccine (inactivated) -PoliorixTM']}], 'interventions': [{'name': 'Poliomyelitis vaccine (inactivated) -PoliorixTM', 'type': 'BIOLOGICAL', 'description': 'Deep intramuscular injections for the primary vaccination and booster vaccination.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}