Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT00750360
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2008-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).', 'otherNumAtRisk': 294, 'otherNumAffected': 9, 'seriousNumAtRisk': 294, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).', 'otherNumAtRisk': 384, 'otherNumAffected': 90, 'seriousNumAtRisk': 384, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).', 'otherNumAtRisk': 79, 'otherNumAffected': 27, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).', 'otherNumAtRisk': 46, 'otherNumAffected': 10, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).', 'otherNumAtRisk': 71, 'otherNumAffected': 11, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'seriousEvents': [{'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Severe Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 21-day follow-up period (Day 0 to Day 20) after vaccination', 'description': 'An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nSevere unsolicited adverse events are defined as adverse events which prevent normal, everyday activities', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B (Unprimed), > 6 Months to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG001', 'title': 'Group A (Primed), > 6 Months to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}], 'classes': [{'title': 'Induration', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sweating/diaphoresis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow up (Day 0 to 3) after vaccination.', 'description': 'Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group B (Unprimed), ≥ 72 Months to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG001', 'title': 'Group A (Primed), ≥ 72 Months to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG002', 'title': 'Group A (Primed), ≥ 108 Months to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG003', 'title': 'Group A (Primed), ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Sweating/diaphoresis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 4-day follow up (Day 0 to 3) after vaccination.', 'description': 'Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participant Reporting Unsolicited Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 21-day follow-up period (Day 0 to Day 20) after vaccination', 'description': 'An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAE).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'OG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'OG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month following vaccination', 'description': 'An SAE is any untoward medical occurrence that:\n\nresults in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'FG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'FG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}, {'id': 'FG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'FG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'FG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Seven subjects enrolled in this group were not vaccinated and as such not included as "STARTED".', 'groupId': 'FG000', 'numSubjects': '294'}, {'comment': 'One subject enrolled in this group was not vaccinated and as such not included as "STARTED".', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '384'}, {'groupId': 'FG003', 'numSubjects': '79'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '384'}, {'groupId': 'FG003', 'numSubjects': '79'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '875', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'BG001', 'title': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).'}, {'id': 'BG002', 'title': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).'}, {'id': 'BG003', 'title': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).'}, {'id': 'BG004', 'title': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'BG005', 'title': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '10.60', 'groupId': 'BG000'}, {'value': '85.0', 'spread': '0', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '18.80', 'groupId': 'BG002'}, {'value': '86.4', 'spread': '10.60', 'groupId': 'BG003'}, {'value': '132.7', 'spread': '22.00', 'groupId': 'BG004'}, {'value': '454.5', 'spread': '174.40', 'groupId': 'BG005'}, {'value': '73.2', 'spread': '128.07', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '445', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '430', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 883}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2008-09-09', 'resultsFirstSubmitDate': '2008-12-23', 'studyFirstSubmitQcDate': '2008-09-09', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-08', 'studyFirstPostDateStruct': {'date': '2008-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Severe Unsolicited Adverse Events', 'timeFrame': 'During the 21-day follow-up period (Day 0 to Day 20) after vaccination', 'description': 'An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.\n\nSevere unsolicited adverse events are defined as adverse events which prevent normal, everyday activities'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.', 'timeFrame': 'During the 4-day follow up (Day 0 to 3) after vaccination.', 'description': 'Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.'}, {'measure': 'Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.', 'timeFrame': 'During the 4-day follow up (Day 0 to 3) after vaccination.', 'description': 'Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.'}, {'measure': 'Number of Participant Reporting Unsolicited Adverse Events.', 'timeFrame': 'During the 21-day follow-up period (Day 0 to Day 20) after vaccination', 'description': 'An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAE).', 'timeFrame': 'Within 1 month following vaccination', 'description': 'An SAE is any untoward medical occurrence that:\n\nresults in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.'}]}, 'conditionsModule': {'keywords': ['Influenza', 'Korea', 'FluarixTM'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '218352/054', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female \\> 6 months of age at the time of the first vaccination.\n* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.\n* Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.\n* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.\n\nExclusion Criteria:\n\n* Clinical signs of acute febrile illness at the time of entry into the study.\n* Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.'}, 'identificationModule': {'nctId': 'NCT00750360', 'briefTitle': 'Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination", 'orgStudyIdInfo': {'id': '218352/054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unprimed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who were previously not vaccinated against influenza (unprimed).', 'interventionNames': ['Biological: FluarixTM']}, {'type': 'EXPERIMENTAL', 'label': 'Unprimed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who were previously not vaccinated against influenza (unprimed).', 'interventionNames': ['Biological: FluarixTM']}, {'type': 'EXPERIMENTAL', 'label': 'Primed, > 6 to < 72 Months', 'description': 'Subjects aged \\> 6 months to \\< 72 months who previously received a vaccination against influenza (primed).', 'interventionNames': ['Biological: FluarixTM']}, {'type': 'EXPERIMENTAL', 'label': 'Primed, ≥ 72 to < 108 Months', 'description': 'Subjects aged ≥ 72 months to \\< 108 months who previously received a vaccination against influenza (primed).', 'interventionNames': ['Biological: FluarixTM']}, {'type': 'EXPERIMENTAL', 'label': 'Primed, ≥ 108 to < 216 Months', 'description': 'Subjects aged ≥ 108 months to \\< 216 months who previously received a vaccination against influenza (primed).', 'interventionNames': ['Biological: FluarixTM']}, {'type': 'EXPERIMENTAL', 'label': 'Primed, ≥ 216 Months', 'description': 'Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).', 'interventionNames': ['Biological: FluarixTM']}], 'interventions': [{'name': 'FluarixTM', 'type': 'BIOLOGICAL', 'description': 'All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).', 'armGroupLabels': ['Primed, > 6 to < 72 Months', 'Primed, ≥ 108 to < 216 Months', 'Primed, ≥ 216 Months', 'Primed, ≥ 72 to < 108 Months', 'Unprimed, > 6 to < 72 Months', 'Unprimed, ≥ 72 to < 108 Months']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}