Viewing Study NCT01051661

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 12:03 PM

Ignite Modification Date: 2025-12-26 @ 12:01 AM

Study NCT ID: NCT01051661

Status: COMPLETED

Last Update Posted: 2021-02-26

First Post: 2010-01-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'India']}, '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': 'C568072', 'term': 'arepanrix'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', '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': 'Solicited local/general symptoms during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs during the 42-day post-vaccination (Days 0-41), SAEs during the entire study period (Day 0 - Day 385).', 'eventGroups': [{'id': 'EG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'otherNumAtRisk': 610, 'deathsNumAtRisk': 610, 'otherNumAffected': 498, 'seriousNumAtRisk': 610, 'deathsNumAffected': 1, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'otherNumAtRisk': 1438, 'deathsNumAtRisk': 1438, 'otherNumAffected': 1116, 'seriousNumAtRisk': 1438, 'deathsNumAffected': 1, 'seriousNumAffected': 41}, {'id': 'EG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'otherNumAtRisk': 612, 'deathsNumAtRisk': 612, 'otherNumAffected': 439, 'seriousNumAtRisk': 612, 'deathsNumAffected': 1, 'seriousNumAffected': 29}, {'id': 'EG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'otherNumAtRisk': 1436, 'deathsNumAtRisk': 1436, 'otherNumAffected': 1047, 'seriousNumAtRisk': 1436, 'deathsNumAffected': 0, 'seriousNumAffected': 37}, {'id': 'EG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months to 3 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'otherNumAtRisk': 613, 'deathsNumAtRisk': 613, 'otherNumAffected': 446, 'seriousNumAtRisk': 613, 'deathsNumAffected': 0, 'seriousNumAffected': 33}, {'id': 'EG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'otherNumAtRisk': 1436, 'deathsNumAtRisk': 1436, 'otherNumAffected': 891, 'seriousNumAtRisk': 1436, 'deathsNumAffected': 0, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 125, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 101, 'numAffected': 92}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 69, 'numAffected': 61}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 222, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 204, 'numAffected': 171}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 151, 'numAffected': 127}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 165, 'numAffected': 135}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 219, 'numAffected': 176}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 136, 'numAffected': 115}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 180, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 133, 'numAffected': 118}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 129, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 77, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 74, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 83, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 321, 'numAffected': 254}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 224, 'numAffected': 188}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 205, 'numAffected': 172}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 313, 'numAffected': 237}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 196, 'numAffected': 162}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 209, 'numAffected': 164}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 176, 'numAffected': 141}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 240, 'numAffected': 190}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 115, 'numAffected': 95}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 211, 'numAffected': 166}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 164, 'numAffected': 140}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 115, 'numAffected': 100}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 417, 'numAffected': 288}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1476, 'numAffected': 941}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 294, 'numAffected': 222}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 1052, 'numAffected': 813}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 208, 'numAffected': 154}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 836, 'numAffected': 580}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 272, 'numAffected': 230}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 279, 'numAffected': 256}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 166, 'numAffected': 151}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 186, 'numAffected': 168}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 136, 'numAffected': 128}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 137, 'numAffected': 125}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 220, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 195, 'numAffected': 160}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 146, 'numAffected': 124}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 172, 'numAffected': 139}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 179, 'numAffected': 149}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 161, 'numAffected': 134}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 95, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 54, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 67, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 100, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 53, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 98, 'numAffected': 91}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 60, 'numAffected': 56}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 111, 'numAffected': 102}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrohoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 110, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 120, 'numAffected': 112}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 90, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 126, 'numAffected': 115}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 109, 'numAffected': 98}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 107, 'numAffected': 99}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 135, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 148, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 129, 'numAffected': 119}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 156, 'numAffected': 144}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 147, 'numAffected': 125}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 145, 'numAffected': 127}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal septum disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urticaria chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sexual abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subgaleal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 610, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 612, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1436, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 1436, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine efficacy increase', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.70', 'ciLowerLimit': '18.53', 'ciUpperLimit': '93.39', 'groupDescription': 'Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \\> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \\>0.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 after first vaccination until study conclusion on Day 385', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 14 days after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 42 days after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Pneumonia Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1940', 'groupId': 'OG000'}, {'value': '1933', 'groupId': 'OG001'}, {'value': '1930', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1903', 'groupId': 'OG000'}, {'value': '1913', 'groupId': 'OG001'}, {'value': '1897', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '745', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}]}]}, {'title': 'Muscle aches all over body', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '668', 'groupId': 'OG000'}, {'value': '626', 'groupId': 'OG001'}, {'value': '634', 'groupId': 'OG002'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '379', 'groupId': 'OG002'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '682', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '649', 'groupId': 'OG002'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}, {'value': '352', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '422', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '326', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1903', 'groupId': 'OG000'}, {'value': '1913', 'groupId': 'OG001'}, {'value': '1897', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '716', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}, {'value': '677', 'groupId': 'OG002'}]}]}, {'title': 'Muscle aches all over body', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '643', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '360', 'groupId': 'OG002'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '656', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}, {'value': '627', 'groupId': 'OG002'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 14 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1903', 'groupId': 'OG000'}, {'value': '1913', 'groupId': 'OG001'}, {'value': '1897', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Muscle aches all over body', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1903', 'groupId': 'OG000'}, {'value': '1913', 'groupId': 'OG001'}, {'value': '1897', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Muscle aches all over body', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 14 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of efficacy, which included all eligible subjects, who received the study vaccine/placebo according to their treatment assignment, and for whom efficacy data were available. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-6Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to less than (\\<) 6 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 2D 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to less than (\\<) 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG003', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG004', 'title': 'Arepanrix 1D 3Y-6Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to less than (\\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG005', 'title': 'Arepanrix 1D 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to less than (\\<) 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG006', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG007', 'title': 'GSK2340273A 3Y-6Y Group', 'description': 'Subjects, male and female, aged 2 years (Y) to less than (\\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG008', 'title': 'GSK2340273A 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to less than (\\<) 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}, {'value': '416', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}, {'value': '357', 'groupId': 'OG004'}, {'value': '409', 'groupId': 'OG005'}, {'value': '122', 'groupId': 'OG006'}, {'value': '212', 'groupId': 'OG007'}, {'value': '254', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}, {'value': '347', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '133', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '157', 'groupId': 'OG007'}, {'value': '213', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '699', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}, {'value': '727', 'groupId': 'OG004'}, {'value': '681', 'groupId': 'OG005'}, {'value': '593', 'groupId': 'OG006'}, {'value': '696', 'groupId': 'OG007'}, {'value': '709', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '487', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}, {'value': '382', 'groupId': 'OG004'}, {'value': '431', 'groupId': 'OG005'}, {'value': '154', 'groupId': 'OG006'}, {'value': '258', 'groupId': 'OG007'}, {'value': '322', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '712', 'groupId': 'OG002'}, {'value': '612', 'groupId': 'OG003'}, {'value': '744', 'groupId': 'OG004'}, {'value': '692', 'groupId': 'OG005'}, {'value': '613', 'groupId': 'OG006'}, {'value': '714', 'groupId': 'OG007'}, {'value': '722', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '612', 'groupId': 'OG002'}, {'value': '744', 'groupId': 'OG003'}, {'value': '613', 'groupId': 'OG004'}, {'value': '714', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-6Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to less than (\\<) 6 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-6Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to less than (\\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to less than (\\<) 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-6Y Group', 'description': 'Subjects, male and female, aged 2 years (Y) to less than (\\<) 6 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). 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'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '612', 'groupId': 'OG002'}, {'value': '744', 'groupId': 'OG003'}, {'value': '613', 'groupId': 'OG004'}, {'value': '714', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '612', 'groupId': 'OG002'}, {'value': '744', 'groupId': 'OG003'}, {'value': '613', 'groupId': 'OG004'}, {'value': '714', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '83', 'groupId': 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Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG001', 'title': 'Arepanrix 1D 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'GSK2340273A 6Y-10Y Group', 'description': 'Subjects, male and female, aged 6 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Any Gastro.sympt., Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Gastro.sympt., Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Related Gastro.sympt., Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 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Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Any Joint pain at other location, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Joint pain at other location, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Joint pain at other location, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Any Muscle aches, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Muscle aches, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Related Muscle aches, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Any Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Related Sweating, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '712', 'groupId': 'OG000'}, {'value': '692', 'groupId': 'OG001'}, {'value': '722', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature \\[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, from the age strata groups, who received at least 1 dose of study vaccine and who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2048', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}, {'value': '2049', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 385', 'description': 'Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. This analysis compared the different treatment groups based on the type of vaccine received.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Medically-attended Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2048', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}, {'value': '2049', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '1189', 'groupId': 'OG000'}, {'value': '1173', 'groupId': 'OG001'}, {'value': '1190', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 385', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2048', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}, {'value': '2049', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '913', 'groupId': 'OG000'}, {'value': '904', 'groupId': 'OG001'}, {'value': '895', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Day 42', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2048', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}, {'value': '2049', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 385', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all subjects, who received at least 1 dose of study vaccine and who filled in their symptom sheets. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12.40', 'groupId': 'OG000', 'lowerLimit': '10.21', 'upperLimit': '15.06'}, {'value': '16.92', 'groupId': 'OG001', 'lowerLimit': '13.77', 'upperLimit': '20.80'}, {'value': '11.19', 'groupId': 'OG002', 'lowerLimit': '9.32', 'upperLimit': '13.43'}, {'value': '14.17', 'groupId': 'OG003', 'lowerLimit': '11.48', 'upperLimit': '17.49'}, {'value': '12.25', 'groupId': 'OG004', 'lowerLimit': '9.97', 'upperLimit': '15.07'}, {'value': '14.76', 'groupId': 'OG005', 'lowerLimit': '12.04', 'upperLimit': '18.10'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1738.90', 'groupId': 'OG000', 'lowerLimit': '1598.65', 'upperLimit': '1891.44'}, {'value': '1345.36', 'groupId': 'OG001', 'lowerLimit': '1228.32', 'upperLimit': '1473.55'}, {'value': '258.02', 'groupId': 'OG002', 'lowerLimit': '219.86', 'upperLimit': '302.79'}, {'value': '279.52', 'groupId': 'OG003', 'lowerLimit': '229.58', 'upperLimit': '340.31'}, {'value': '188.89', 'groupId': 'OG004', 'lowerLimit': '156.13', 'upperLimit': '228.53'}, {'value': '443.98', 'groupId': 'OG005', 'lowerLimit': '367.03', 'upperLimit': '537.04'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 42', 'description': 'Titers are presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '73', 'groupId': 'OG005'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 42', 'description': 'A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}, {'value': '187', 'groupId': 'OG004'}, {'value': '155', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}, {'value': '164', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '160', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 42', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with both doses of study vaccine/placebo administered per protocol treatment assignment and assay results for antibodies against A/California at the relevant timepoints were available.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}, {'value': '220', 'groupId': 'OG004'}, {'value': '161', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '140.8', 'groupId': 'OG000', 'lowerLimit': '116.6', 'upperLimit': '170.0'}, {'value': '79.9', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '97.6'}, {'value': '23.4', 'groupId': 'OG002', 'lowerLimit': '21.2', 'upperLimit': '25.7'}, {'value': '20.3', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '23.3'}, {'value': '15.6', 'groupId': 'OG004', 'lowerLimit': '13.5', 'upperLimit': '18.0'}, {'value': '29.9', 'groupId': 'OG005', 'lowerLimit': '25.1', 'upperLimit': '35.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoints.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 1D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG001', 'title': 'Arepanrix 2D Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}, {'id': 'OG002', 'title': 'GSK2340273A Group', 'description': 'Subjects, male and female, aged 6 months to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh. This group pooled the subjects from the 6M-3Y and 3Y-10Y age strata.'}], 'classes': [{'categories': [{'measurements': [{'value': '278.9', 'groupId': 'OG000'}, {'value': '1548.5', 'groupId': 'OG001'}, {'value': '275.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted GMT ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.61', 'ciLowerLimit': '4.92', 'ciUpperLimit': '6.41', 'groupDescription': 'Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted GMT ratios', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.19', 'groupDescription': 'Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 42', 'description': 'The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol.', 'unitOfMeasure': 'Adjusted GMT ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 42, which included all evaluable subjects with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint. The groups were pooled, based on the type of vaccine received and regardless the age strata.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12.62', 'groupId': 'OG000', 'lowerLimit': '8.79', 'upperLimit': '18.12'}, {'value': '11.79', 'groupId': 'OG001', 'lowerLimit': '7.90', 'upperLimit': '17.60'}, {'value': '9.77', 'groupId': 'OG002', 'lowerLimit': '7.23', 'upperLimit': '13.22'}, {'value': '17.57', 'groupId': 'OG003', 'lowerLimit': '12.16', 'upperLimit': '25.40'}, {'value': '14.22', 'groupId': 'OG004', 'lowerLimit': '9.03', 'upperLimit': '22.40'}, {'value': '12.19', 'groupId': 'OG005', 'lowerLimit': '8.43', 'upperLimit': '17.63'}]}]}, {'title': 'Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '287.22', 'groupId': 'OG000', 'lowerLimit': '246.77', 'upperLimit': '334.29'}, {'value': '238.25', 'groupId': 'OG001', 'lowerLimit': '213.25', 'upperLimit': '266.18'}, {'value': '76.52', 'groupId': 'OG002', 'lowerLimit': '61.99', 'upperLimit': '94.46'}, {'value': '108.59', 'groupId': 'OG003', 'lowerLimit': '94.10', 'upperLimit': '125.30'}, {'value': '74.94', 'groupId': 'OG004', 'lowerLimit': '59.09', 'upperLimit': '95.05'}, {'value': '145.06', 'groupId': 'OG005', 'lowerLimit': '128.28', 'upperLimit': '164.03'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 182', 'description': 'Titers are presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '384', 'groupId': 'OG003'}, {'value': '174', 'groupId': 'OG004'}, {'value': '377', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 182', 'description': 'A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 182', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Day 182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}, {'value': '184', 'groupId': 'OG004'}, {'value': '379', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '288', 'groupId': 'OG003'}, {'value': '117', 'groupId': 'OG004'}, {'value': '337', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 182', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '31.1'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '25.8'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '9.3'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '7.9'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '6.3'}, {'value': '8.5', 'groupId': 'OG005', 'lowerLimit': '6.4', 'upperLimit': '11.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 182', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 182, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.62', 'groupId': 'OG000', 'lowerLimit': '6.76', 'upperLimit': '13.69'}, {'value': '15.71', 'groupId': 'OG001', 'lowerLimit': '9.76', 'upperLimit': '25.27'}, {'value': '9.93', 'groupId': 'OG002', 'lowerLimit': '6.71', 'upperLimit': '14.71'}, {'value': '14.92', 'groupId': 'OG003', 'lowerLimit': '8.99', 'upperLimit': '24.74'}, {'value': '10.13', 'groupId': 'OG004', 'lowerLimit': '7.04', 'upperLimit': '14.56'}, {'value': '13.57', 'groupId': 'OG005', 'lowerLimit': '8.50', 'upperLimit': '21.66'}]}]}, {'title': 'Day 385', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '265.61', 'groupId': 'OG000', 'lowerLimit': '228.92', 'upperLimit': '308.18'}, {'value': '189.44', 'groupId': 'OG001', 'lowerLimit': '169.64', 'upperLimit': '211.55'}, {'value': '112.56', 'groupId': 'OG002', 'lowerLimit': '91.27', 'upperLimit': '138.81'}, {'value': '103.57', 'groupId': 'OG003', 'lowerLimit': '89.90', 'upperLimit': '119.32'}, {'value': '54.90', 'groupId': 'OG004', 'lowerLimit': '42.15', 'upperLimit': '71.50'}, {'value': '92.33', 'groupId': 'OG005', 'lowerLimit': '80.18', 'upperLimit': '106.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 385', 'description': 'Titers are presented as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Day 385', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '333', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 385', 'description': 'A seropositive subject was defined as a subject whose HI titers was greater than or equal to (≥) 1:10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 385', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'title': 'Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Day 385', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '344', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '266', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '259', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 385', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'OG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'OG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '35.3'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '19.0'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '11.0'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '9.4'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '2.8', 'upperLimit': '4.7'}, {'value': '6.1', 'groupId': 'OG005', 'lowerLimit': '4.2', 'upperLimit': '8.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 385', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity - Day 385, which included all evaluable subjects from Arepanrix age strata groups and subjects from main GSK2340273A Group, with study vaccine/placebo administered per protocol and assay results available at the relevant timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'FG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'FG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'FG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'FG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'FG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '610'}, {'groupId': 'FG001', 'numSubjects': '1438'}, {'groupId': 'FG002', 'numSubjects': '612'}, {'groupId': 'FG003', 'numSubjects': '1436'}, {'groupId': 'FG004', 'numSubjects': '613'}, {'groupId': 'FG005', 'numSubjects': '1436'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '576'}, {'groupId': 'FG001', 'numSubjects': '1375'}, {'groupId': 'FG002', 'numSubjects': '573'}, {'groupId': 'FG003', 'numSubjects': '1380'}, {'groupId': 'FG004', 'numSubjects': '578'}, {'groupId': 'FG005', 'numSubjects': '1369'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '35'}, {'groupId': 'FG005', 'numSubjects': '67'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '24'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Refused blood sampling', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Data not reliable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Unable to attend visit(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Consent not received from both parents', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Failure to comply with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject lost legal representation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '34'}]}]}], 'preAssignmentDetails': 'Out of the 1654 subjects enrolled, study vaccine was not administered but subject number was allocated to 9 subjects. These 9 subjects were excluded from the study, therefore leading to 1645 subjects starting the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '610', 'groupId': 'BG000'}, {'value': '1438', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}, {'value': '1436', 'groupId': 'BG003'}, {'value': '613', 'groupId': 'BG004'}, {'value': '1436', 'groupId': 'BG005'}, {'value': '6145', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'BG001', 'title': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'BG002', 'title': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'BG003', 'title': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'BG004', 'title': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.'}, {'id': 'BG005', 'title': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '23.8', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '73.2', 'spread': '24.2', 'groupId': 'BG003'}, {'value': '21.2', 'spread': '8.6', 'groupId': 'BG004'}, {'value': '73.2', 'spread': '24.3', 'groupId': 'BG005'}, {'value': '57.7', 'spread': '31.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '688', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}, {'value': '748', 'groupId': 'BG003'}, {'value': '291', 'groupId': 'BG004'}, {'value': '732', 'groupId': 'BG005'}, {'value': '3058', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '750', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}, {'value': '688', 'groupId': 'BG003'}, {'value': '322', 'groupId': 'BG004'}, {'value': '704', 'groupId': 'BG005'}, {'value': '3087', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage/African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}]}]}, {'title': 'Asian-Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Asian-East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}, {'title': 'Asian-Japanese Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Asian-South East Asian Heritage', 'categories': [{'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}, {'value': '503', 'groupId': 'BG003'}, {'value': '297', 'groupId': 'BG004'}, {'value': '499', 'groupId': 'BG005'}, {'value': '2404', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or other Pacific islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'White-Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'White-Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}, {'value': '693', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '731', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '745', 'groupId': 'BG003'}, {'value': '243', 'groupId': 'BG004'}, {'value': '734', 'groupId': 'BG005'}, {'value': '2934', 'groupId': 'BG006'}]}]}], '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': 6154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2011-11-10', 'completionDateStruct': {'date': '2011-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2010-01-14', 'dispFirstSubmitQcDate': '2011-11-10', 'resultsFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2010-01-14', 'dispFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-30', 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}, {'measure': 'Number of Subjects Reporting at Least One A/California Influenza Event', 'timeFrame': 'From Day 0 until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}, {'measure': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.'}, {'measure': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.'}, {'measure': 'Number of Subjects Reporting at Least One Culture Confirmed A/California Influenza Event', 'timeFrame': 'From Day 0 until study conclusion on Day 385', 'description': 'The influenza virus presence was confirmed by a positive culture.'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From 14 days after first vaccination until study conclusion on Day 385'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From 42 days after first vaccination until study conclusion on Day 385'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From Day 0 after first vaccination until study conclusion on Day 385'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From 14 days after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From 42 days after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}, {'measure': 'Number of Subjects With at Least One Pneumonia Event', 'timeFrame': 'From Day 0 after first vaccination until study conclusion at Day 385', 'description': 'Pneumonia was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).'}, {'measure': 'Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases', 'timeFrame': 'From Day 0 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.'}, {'measure': 'Number of Subjects With Protocol Specified Influenza-like Illness (ILI) Symptoms in All Reported ILI Cases', 'timeFrame': 'From Day 14 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.'}, {'measure': 'Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases', 'timeFrame': 'From Day 0 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue.'}, {'measure': 'Number of Subjects With Protocol Specified ILI Symptoms in RT-qPCR-confirmed A/California Influenza Cases', 'timeFrame': 'From Day 14 until study end at Day 385', 'description': 'Protocol specified ILI symptoms were: fever, muscle aches all over the body, cough, sore throat, runny or stuffy nose, short of breath, headache, vomiting, diarrhea, chills and fatigue. Analysis for the time frame Day 42 till Day 385 was not performed as planned per protocol.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged 6 Months to Less Than 6 Years', 'timeFrame': 'During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses', 'description': 'Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \\[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness which prevented normal everyday activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Children Aged Between 6 to 10 Years', 'timeFrame': 'During the 7-day follow-up period (Day 0 - Day 6) after each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (gastro.sympt.), headache, joint pain at other location, muscle aches, shivering, sweating and temperature \\[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\]. Any = Incidence of a particular symptom regardless of intensity grade or relationship to study vaccination. Grade 3 = symptom which prevented normal everyday activity. Grade 3 temperature = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'Up to Day 385', 'description': 'Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects With Any Medically-attended Adverse Events (MAEs)', 'timeFrame': 'Up to Day 385', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'From Day 0 to Day 42', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 385', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 42', 'description': 'Titers are presented as geometric mean titers (GMTs).'}, {'measure': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 42', 'description': 'A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.'}, {'measure': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 42', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.'}, {'measure': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 42', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.'}, {'measure': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 42', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post-vaccination compared to Day 0.'}, {'measure': 'Geometric Mean Antibody Titer Ratio Adjusted for Baseline Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)', 'timeFrame': 'At Day 42', 'description': 'The geometric mean titer ratio (GMT ratio) was defined as the ratio of geometric mean of the post-vaccination reciprocal HI titer between groups. The analysis was not performed for Day 182 and Day 385 as planned per protocol.'}, {'measure': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1)', 'timeFrame': 'At Days 0 and 182', 'description': 'Titers are presented as geometric mean titers (GMTs).'}, {'measure': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 182', 'description': 'A seropositive subject was defined as a subject whose HI titers were greater than or equal to (≥) 1:10.'}, {'measure': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 182', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.'}, {'measure': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 182', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.'}, {'measure': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 182', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.'}, {'measure': 'Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 385', 'description': 'Titers are presented as geometric mean titers (GMTs).'}, {'measure': 'Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 385', 'description': 'A seropositive subject was defined as a subject whose HI titers was greater than or equal to (≥) 1:10.'}, {'measure': 'Number of Seroconverted (SCR) Subjects for Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 385', 'description': 'Seroconversion was defined as: for initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; and for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.'}, {'measure': 'Number of Seroprotected (SPR) Subjects Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Days 0 and 385', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.'}, {'measure': 'Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 (H1N1) Influenza Strain', 'timeFrame': 'At Day 385', 'description': 'The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.'}]}, 'conditionsModule': {'keywords': ['Influenza', 'H1N1', 'Pandemic'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '114000', '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': '114000', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114000', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114000', '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': '114000', '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': '114000', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '24652494', 'type': 'BACKGROUND', 'citation': 'Nolan T, Roy-Ghanta S, Montellano M, Weckx L, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Safadi MA, Cruz-Valdez A, Litao S, Lim FS, de Los Santos AM, Weber MA, Tinoco JC, Mezerville MH, Faingezicht I, Kosuwon P, Lopez P, Borja-Tabora C, Li P, Durviaux S, Fries L, Dubin G, Breuer T, Innis BL, Vaughn DW. Relative efficacy of AS03-adjuvanted pandemic influenza A(H1N1) vaccine in children: results of a controlled, randomized efficacy trial. J Infect Dis. 2014 Aug 15;210(4):545-57. doi: 10.1093/infdis/jiu173. Epub 2014 Mar 20.'}, {'pmid': '27667752', 'type': 'DERIVED', 'citation': 'Taylor S, Lopez P, Weckx L, Borja-Tabora C, Ulloa-Gutierrez R, Lazcano-Ponce E, Kerdpanich A, Angel Rodriguez Weber M, Mascarenas de Los Santos A, Tinoco JC, Safadi MA, Lim FS, Hernandez-de Mezerville M, Faingezicht I, Cruz-Valdez A, Feng Y, Li P, Durviaux S, Haars G, Roy-Ghanta S, Vaughn DW, Nolan T. Respiratory viruses and influenza-like illness: Epidemiology and outcomes in children aged 6 months to 10 years in a multi-country population sample. J Infect. 2017 Jan;74(1):29-41. doi: 10.1016/j.jinf.2016.09.003. Epub 2016 Sep 22.'}], '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 characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female children 6 months to less than 10 years of age at the time of the first vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of first vaccine dose under this protocol.\n* Written informed consent obtained from the subject\'s parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements).\n* Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment.\n* Parent(s)/LAR(s) available and accessible for active surveillance contacts.\n* Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator\'s opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document.\n* Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.\n\nExclusion Criteria:\n\n* Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.\n* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.\n* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/LAR(s) unable/unlikely to provide accurate safety reports.\n* Presence of a temperature ≥ 38.0ºC (≥ 100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.\n* Diagnosed with cancer, or treatment for cancer, within 3 years.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.\n* Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.\n* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.\n* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.\n* Administration of any licensed live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination.\n* Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.\n* Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period.\n* Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before the first dose of study vaccine, or planned use during the study period.\n* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.\n* Child in care.'}, 'identificationModule': {'nctId': 'NCT01051661', 'briefTitle': 'Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Evaluate the Safety and Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children Aged 6 Months to Less Than 10 Years of Age', 'orgStudyIdInfo': {'id': '114000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arepanrix 2D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)"]}, {'type': 'EXPERIMENTAL', 'label': 'Arepanrix 2D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)"]}, {'type': 'EXPERIMENTAL', 'label': 'Arepanrix 1D 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)", 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arepanrix 1D 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)", 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GSK2340273A 6M-3Y Group', 'description': 'Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \\<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \\<12 months of age, in the right anterolateral thigh.', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)"]}, {'type': 'EXPERIMENTAL', 'label': 'GSK2340273A 3Y-10Y Group', 'description': 'Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).', 'interventionNames': ["Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)"]}], 'interventions': [{'name': "GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)", 'type': 'BIOLOGICAL', 'otherNames': ['Arepanrix'], 'description': 'Intramuscular injection, one or two doses', 'armGroupLabels': ['Arepanrix 1D 3Y-10Y Group', 'Arepanrix 1D 6M-3Y Group', 'Arepanrix 2D 3Y-10Y Group', 'Arepanrix 2D 6M-3Y Group']}, {'name': "GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)", 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, two doses', 'armGroupLabels': ['GSK2340273A 3Y-10Y Group', 'GSK2340273A 6M-3Y Group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, one dose', 'armGroupLabels': ['Arepanrix 1D 3Y-10Y Group', 'Arepanrix 1D 6M-3Y Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '88025 300', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'zip': '04038 001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}, {'zip': '3400', 'city': 'Durango', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.02032, 'lon': -104.65756}}, {'zip': '04530', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Monterrey', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '1781', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '4114', 'city': 'Dasmariñas, Cavite', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '1008', 'city': 'Sampaloc, Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '768826', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicalstudydatarequest.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD is available via the Clinical Study Data Request site (click on the link provided below)', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}