Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
Study NCT ID:
NCT01974895
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.', 'description': 'For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.', 'eventGroups': [{'id': 'EG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.', 'otherNumAtRisk': 158, 'otherNumAffected': 115, 'seriousNumAtRisk': 158, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.', 'otherNumAtRisk': 156, 'otherNumAffected': 103, 'seriousNumAtRisk': 156, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability/fussiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'Assessed during the 7-day (Days 0-6) post-vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'Assessed duringthe 4-day (Days 0-3) post-vaccination period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'H1N1 [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.', 'groupId': 'OG001'}]}]}, {'title': 'H3N2 [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.', 'groupId': 'OG001'}]}]}, {'title': 'Victoria [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'This primary outcome concerns solely subjects in the FluLaval Quadrivalent Group.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.\n\nThe vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'H1N1, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This outcome concerns solely subjects in the Fluzone Group.', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This outcome concerns solely subjects in the Fluzone Group.', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This outcome concerns solely subjects in the Fluzone Group.', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'This outcome concerns solely subjects in the Fluzone Group.', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.\n\nThe vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'H1N1, [Day 0]', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '12.3'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '11.9'}]}]}, {'title': 'H1N1, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '141.3', 'groupId': 'OG000', 'lowerLimit': '115.1', 'upperLimit': '173.5'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '112.6'}]}]}, {'title': 'H3N2, [Day 0]', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '13.5'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '14.2'}]}]}, {'title': 'H3N2, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '100.6', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '122.6'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '70.6', 'upperLimit': '105.4'}]}]}, {'title': 'Yamagata, [Day 0]', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '17.5'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '14.7'}]}]}, {'title': 'Yamagata, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '212.0', 'groupId': 'OG000', 'lowerLimit': '174.6', 'upperLimit': '257.3'}, {'value': '140.0', 'groupId': 'OG001', 'lowerLimit': '113.9', 'upperLimit': '172.0'}]}]}, {'title': 'Victoria, [Day 0]', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '9.1'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.5'}]}]}, {'title': 'Victoria, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '86.6'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '15.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)', 'description': 'HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'H1N1, [Day 0]', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'H1N1, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, [Day 0]', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'H3N2, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, [Day 0]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Yamagata, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, [Day 0]', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Victoria, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)', 'description': 'A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'H1N1, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '13.73', 'groupId': 'OG000', 'lowerLimit': '11.10', 'upperLimit': '16.99'}, {'value': '9.11', 'groupId': 'OG001', 'lowerLimit': '7.32', 'upperLimit': '11.33'}]}]}, {'title': 'H3N2, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '9.09', 'groupId': 'OG000', 'lowerLimit': '7.69', 'upperLimit': '10.76'}, {'value': '7.53', 'groupId': 'OG001', 'lowerLimit': '6.36', 'upperLimit': '8.90'}]}]}, {'title': 'Yamagata, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '14.59', 'groupId': 'OG000', 'lowerLimit': '11.72', 'upperLimit': '18.16'}, {'value': '11.36', 'groupId': 'OG001', 'lowerLimit': '9.09', 'upperLimit': '14.19'}]}]}, {'title': 'Victoria, [Day 28 = primed and Day 56 = unprimed]', 'categories': [{'measurements': [{'value': '8.94', 'groupId': 'OG000', 'lowerLimit': '7.34', 'upperLimit': '10.89'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.19'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \\>100mm.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Drowsiness', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Drowsiness', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Any Irritability/fussiness', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Irritability/fussiness', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Related Irritability/fussiness', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Any Loss of appetite', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Loss of appetite', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Loss of appetite', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination', 'description': 'Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited Local and General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Pain [Dose 1; N=43,44]', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Pain [Dose 2; N=21,11]', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Redness [Dose 1; N=2,0]', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Redness [Dose 2; N=0,0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants with event', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants with event', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Swelling [Dose 1; N=0,1]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants with event', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'Swelling [Dose 2; N=0,0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants with event', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No participants with event', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Fever [Dose 1; N=7,8]', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}, {'title': 'Fever [Dose 2; N=3,4]', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Drowsiness [Dose 1; N=56;48]', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Drowsiness [Dose 2; N=22,20]', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Irritability/fussiness [Dose 1; N=64,62]', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}, {'title': 'Irritability/fussiness [Dose 2; N=34,27]', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Loss of appetite [Dose 1; N=41,40]', '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': 'Loss of appetite [Dose 2; N=17,13]', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Duration was defined as number of days with any grade of local and general symptoms.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any MAE(s)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Related MAE(s)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 to Day 180)', 'description': 'MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any pIMD(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related pIMD(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 to Day 180)', 'description': 'pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any Unsolicited AEs', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Unsolicited AEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Related Unsolicited AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination', 'description': 'An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'OG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'FG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other (Missed Visit)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other (Reason unknown)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Not all subjects who withdrew from the study were willing to provide a reason for withdrawal. Thus, the reasons for withdrawal for these subjects are unknown.', 'preAssignmentDetails': '2 subjects were allocated subject numbers but study vaccine was not administered, thus were excluded from the study prior to group assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.'}, {'id': 'BG001', 'title': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '19.8', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '19.7', 'spread': '8.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-23'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2013-10-23', 'resultsFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-09', 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.\n\nThe vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}], 'secondaryOutcomes': [{'measure': 'Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.\n\nThe vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains', 'timeFrame': 'On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)', 'description': 'HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.', 'timeFrame': 'At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)', 'description': 'A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.', 'timeFrame': '28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)', 'description': 'MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \\>100mm.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Fever', 'timeFrame': 'During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination', 'description': 'Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Duration of Solicited Local and General Symptoms', 'timeFrame': 'During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination', 'description': 'Duration was defined as number of days with any grade of local and general symptoms.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)', 'timeFrame': 'During the entire study period (Day 0 to Day 180)', 'description': 'MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)', 'timeFrame': 'During the entire study period (Day 0 to Day 180)', 'description': 'pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).', 'timeFrame': 'During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination', 'description': 'An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010'}, {'measure': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (Day 0 - Day 180)', 'description': 'A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.\n\nVaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.\n\nVaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.'}]}, 'conditionsModule': {'keywords': ['Children', 'Immunogenicity', 'Fluzone®', '6 to 35 months of age', 'Seasonal influenza', 'Safety'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '200806', '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': '200806', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '200806', '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': '200806', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '200806', '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': '200806', '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': '200806', '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 purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.", 'detailedDescription': 'The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to explore response to vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects' parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.\n* A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n* Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.\n* Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.\n* Child in care.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.\n* Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.\n* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.\n* Acute disease and/or fever at the time of enrollment.\n\n * Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.\n * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.\n* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study."}, 'identificationModule': {'nctId': 'NCT01974895', 'briefTitle': "Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age", 'orgStudyIdInfo': {'id': '200806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FluLaval Quadrivalent Group', 'description': 'Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.', 'interventionNames': ['Biological: FluLaval® Quadrivalent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzone Group', 'description': 'Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.', 'interventionNames': ['Biological: Fluzone®']}], 'interventions': [{'name': 'FluLaval® Quadrivalent', 'type': 'BIOLOGICAL', 'otherNames': ['GSK2282512A'], 'description': '1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \\<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.', 'armGroupLabels': ['FluLaval Quadrivalent Group']}, {'name': 'Fluzone®', 'type': 'BIOLOGICAL', 'description': '1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \\<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.', 'armGroupLabels': ['Fluzone Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95822', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '91790', 'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.06862, 'lon': -117.93895}}, {'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}, {'zip': '49127', 'city': 'Stevensville', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.01449, 'lon': -86.51947}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '44121', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '16148', 'city': 'Hermitage', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.23339, 'lon': -80.44868}}, {'zip': '29812', 'city': 'Barnwell', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.24487, 'lon': -81.35872}}, {'zip': '29520', 'city': 'Cheraw', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.69766, 'lon': -79.8834}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], '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'}}}}