Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 1:53 PM
Study NCT ID:
NCT00938392
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'timeFrame': 'Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.', 'description': 'Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.', 'eventGroups': [{'id': 'EG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).', 'otherNumAtRisk': 362, 'otherNumAffected': 242, 'seriousNumAtRisk': 362, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).', 'otherNumAtRisk': 362, 'otherNumAffected': 252, 'seriousNumAtRisk': 362, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pain at the injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 190}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness at the injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling at the injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 98}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 82}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 62}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 362, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'A/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '15.8'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '14.9'}]}]}, {'title': 'A/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.4', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '122.6'}, {'value': '108.7', 'groupId': 'OG001', 'lowerLimit': '95.1', 'upperLimit': '124.1'}]}]}, {'title': 'A/Uruguay [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '21.3'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '21.8'}]}]}, {'title': 'A/Uruguay [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '291.5', 'groupId': 'OG000', 'lowerLimit': '251.9', 'upperLimit': '337.4'}, {'value': '282.7', 'groupId': 'OG001', 'lowerLimit': '244.6', 'upperLimit': '326.8'}]}]}, {'title': 'B/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '78.4'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '54.8', 'upperLimit': '70.7'}]}]}, {'title': 'B/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '537.9', 'groupId': 'OG000', 'lowerLimit': '483.6', 'upperLimit': '598.3'}, {'value': '534.2', 'groupId': 'OG001', 'lowerLimit': '483.5', 'upperLimit': '590.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 21', 'description': 'Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seropositive Against the 3 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'A/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '353', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 21', 'description': 'A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seroconverted for the 3 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'A/Brisbane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor for the 3 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'A/Brisbane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '8.9'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '9.5'}]}]}, {'title': 'A/Uruguay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '13.4', 'upperLimit': '18.6'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '17.3'}]}]}, {'title': 'B/Brisbane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '9.3'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '9.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.', 'unitOfMeasure': 'Fold Increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Seroprotected for the 3 Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'A/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'A/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'A/Uruguay [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '338', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [Day 0]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane [Day 21]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 21', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'Any Ecchymosis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Ecchymosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Any Muscle aches', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Muscle aches', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Muscle aches', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day post-vaccination period', 'description': 'Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \\[oral temperature greater than or equal to 38 degrees Celsius (°C)\\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited Local and General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'Ecchymosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Arthralgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Gastrointestinal symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Muscle aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the 7-day post-vaccination period', 'description': 'Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21-day post-vaccination period', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Adverse Events of Specific Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21-day post-vaccination period', 'description': 'AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'OG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (up to Day 21)', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'FG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '358'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '724', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'BG001', 'title': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '6.09', 'groupId': 'BG000'}, {'value': '73.5', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '6.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-30'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2009-11-10', 'completionDateStruct': {'date': '2009-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2009-07-09', 'dispFirstSubmitQcDate': '2009-11-10', 'resultsFirstSubmitDate': '2012-04-19', 'studyFirstSubmitQcDate': '2009-07-09', 'dispFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-19', 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains', 'timeFrame': 'At Days 0 and 21', 'description': 'Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Seropositive Against the 3 Vaccine Strains', 'timeFrame': 'At Days 0 and 21', 'description': 'A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.'}, {'measure': 'Number of Subjects Seroconverted for the 3 Vaccine Strains', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.'}, {'measure': 'Seroconversion Factor for the 3 Vaccine Strains', 'timeFrame': 'At Day 21', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.'}, {'measure': 'Number of Subjects Seroprotected for the 3 Vaccine Strains', 'timeFrame': 'At Days 0 and 21', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day post-vaccination period', 'description': 'Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \\[oral temperature greater than or equal to 38 degrees Celsius (°C)\\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.'}, {'measure': 'Duration of Solicited Local and General Symptoms', 'timeFrame': 'During the 7-day post-vaccination period', 'description': 'Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 21-day post-vaccination period', 'description': 'Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects Reporting Adverse Events of Specific Interest (AESI)', 'timeFrame': 'During the 21-day post-vaccination period', 'description': 'AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (up to Day 21)', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['influenza infection', "GSK Bio's influenza vaccine GSK2186877A"], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '112662', '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'}, {'id': '112662', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112662', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112662', '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': '112662', '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': '112662', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '112662', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', '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 objective of the study is to evaluate immunogenicity between different formulations of GSK Biologicals' investigational vaccine GSK2186877A."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.\n* A man or woman 65 years of age or older at the time of vaccination.\n* Written informed consent obtained from the subject.\n* Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.\n\nExclusion Criteria:\n\n* Any confirmed or suspected influenza illness within the last 6 months.\n* Previous vaccination against influenza with any seasonal vaccine since December 2008.\n* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.\n* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 2.\n* Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone \\>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein, included history of hypersensitivity to a previous dose of influenza vaccine.\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n* Acute disease and/or fever at the time of enrolment.\n\n * Fever is defined as temperature \\>= 37.5°C on oral setting.\n * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.\n* Any medical conditions in which intramuscular injections are contraindicated.'}, 'identificationModule': {'nctId': 'NCT00938392', 'briefTitle': 'Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Adults.", 'orgStudyIdInfo': {'id': '112662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FluNG Aged Group', 'description': 'Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).', 'interventionNames': ['Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot']}, {'type': 'EXPERIMENTAL', 'label': 'FluNG Fresh Group', 'description': 'Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).', 'interventionNames': ['Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot']}], 'interventions': [{'name': 'GSK investigational FluNG vaccine GSK2186877A, aged lot', 'type': 'BIOLOGICAL', 'description': 'Single dose, intramuscular injection', 'armGroupLabels': ['FluNG Aged Group']}, {'name': 'GSK investigational FluNG vaccine GSK2186877A, fresh lot', 'type': 'BIOLOGICAL', 'description': 'Single dose, intramuscular injection', 'armGroupLabels': ['FluNG Fresh Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallinn', 'country': 'Estonia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50106', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '811 03', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '814 66', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '841 04', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '900 24', 'city': 'Veľký Biel', 'country': 'Slovakia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.21335, 'lon': 17.3608}}], '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'}}}}