Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-25 @ 3:37 PM
Study NCT ID:
NCT00306995
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2006-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.', 'description': 'One subject from the SB218352\\_15 Group reported both SAE(s) included in the Adverse Events section.', 'eventGroups': [{'id': 'EG000', 'title': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 26, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 16, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SB218352_4 Group', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 14, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 28, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 22, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 24, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 22, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '35.0'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '22.1'}, {'value': '14.6', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '20.8'}, {'value': '9.8', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '12.8'}, {'value': '23.3', 'groupId': 'OG004', 'lowerLimit': '16.9', 'upperLimit': '32.0'}, {'value': '18.8', 'groupId': 'OG005', 'lowerLimit': '12.3', 'upperLimit': '28.5'}, {'value': '16.9', 'groupId': 'OG006', 'lowerLimit': '12.3', 'upperLimit': '23.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '47.8'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '28.9'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '34.8'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '9.1', 'upperLimit': '15.9'}, {'value': '42.1', 'groupId': 'OG004', 'lowerLimit': '28.7', 'upperLimit': '61.7'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '13.3', 'upperLimit': '30.0'}, {'value': '17.8', 'groupId': 'OG006', 'lowerLimit': '12.9', 'upperLimit': '24.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor for Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '2.9'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '1.7'}, {'value': '3.1', 'groupId': 'OG004', 'lowerLimit': '2.3', 'upperLimit': '4.2'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '2.4', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '3.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor for Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '5.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '5.0'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.2'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '8.4'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '3.9'}, {'value': '2.5', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '3.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Seroprotection Power Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '21', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '10', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Seroprotection Power Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '21', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '8', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-days (Day 0-30) post vaccination', '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 analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 to Day 51', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the 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'lowerLimit': '1073.00', 'upperLimit': '1873.00'}, {'value': '989.50', 'groupId': 'OG005', 'lowerLimit': '734.00', 'upperLimit': '1912.50'}, {'value': '972.50', 'groupId': 'OG006', 'lowerLimit': '820.00', 'upperLimit': '1466.00'}]}]}, {'title': 'CD4-ALL DOUBLES, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1100.00', 'groupId': 'OG000', 'lowerLimit': '733.00', 'upperLimit': '1567.00'}, {'value': '1349.00', 'groupId': 'OG001', 'lowerLimit': '722.00', 'upperLimit': '1812.00'}, {'value': '967.00', 'groupId': 'OG002', 'lowerLimit': '647.00', 'upperLimit': '1693.00'}, {'value': '965.00', 'groupId': 'OG003', 'lowerLimit': '651.00', 'upperLimit': '1645.00'}, {'value': '1600.00', 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{'value': '1161.00', 'groupId': 'OG004', 'lowerLimit': '630.00', 'upperLimit': '1639.00'}, {'value': '1158.00', 'groupId': 'OG005', 'lowerLimit': '760.00', 'upperLimit': '1378.00'}, {'value': '886.00', 'groupId': 'OG006', 'lowerLimit': '613.00', 'upperLimit': '1399.00'}]}]}, {'title': 'CD4-CD40L, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1069.00', 'groupId': 'OG000', 'lowerLimit': '851.00', 'upperLimit': '1320.00'}, {'value': '1243.50', 'groupId': 'OG001', 'lowerLimit': '730.00', 'upperLimit': '1511.00'}, {'value': '1074.00', 'groupId': 'OG002', 'lowerLimit': '752.00', 'upperLimit': '1483.00'}, {'value': '788.50', 'groupId': 'OG003', 'lowerLimit': '376.00', 'upperLimit': 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'lowerLimit': '-108.00', 'upperLimit': '451.50'}, {'value': '172.50', 'groupId': 'OG002', 'lowerLimit': '3.50', 'upperLimit': '478.00'}, {'value': '78.50', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '438.00'}, {'value': '167.00', 'groupId': 'OG004', 'lowerLimit': '92.00', 'upperLimit': '427.00'}, {'value': '165.00', 'groupId': 'OG005', 'lowerLimit': '23.00', 'upperLimit': '273.00'}, {'value': '72.50', 'groupId': 'OG006', 'lowerLimit': '-54.50', 'upperLimit': '375.00'}]}]}, {'title': 'CD4-IFN-γ, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '107.00', 'groupId': 'OG000', 'lowerLimit': '-58.00', 'upperLimit': '256.00'}, {'value': '120.00', 'groupId': 'OG001', 'lowerLimit': '-34.00', 'upperLimit': '442.00'}, {'value': '205.00', 'groupId': 'OG002', 'lowerLimit': '-3.00', 'upperLimit': '343.00'}, {'value': '77.50', 'groupId': 'OG003', 'lowerLimit': '-41.00', 'upperLimit': '304.00'}, {'value': '145.50', 'groupId': 'OG004', 'lowerLimit': '57.00', 'upperLimit': '506.00'}, {'value': '229.00', 'groupId': 'OG005', 'lowerLimit': '-57.00', 'upperLimit': '600.00'}, {'value': '150.00', 'groupId': 'OG006', 'lowerLimit': '83.00', 'upperLimit': '260.00'}]}]}, {'title': 'CD4-IFN-γ, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '125.00', 'groupId': 'OG000', 'lowerLimit': '27.00', 'upperLimit': '196.00'}, {'value': '145.00', 'groupId': 'OG001', 'lowerLimit': '-115.00', 'upperLimit': '236.00'}, {'value': '124.00', 'groupId': 'OG002', 'lowerLimit': '8.50', 'upperLimit': '350.50'}, {'value': '136.00', 'groupId': 'OG003', 'lowerLimit': '60.00', 'upperLimit': '248.00'}, {'value': '320.00', 'groupId': 'OG004', 'lowerLimit': '-19.00', 'upperLimit': '621.00'}, {'value': '186.00', 'groupId': 'OG005', 'lowerLimit': '103.00', 'upperLimit': '375.00'}, {'value': '233.50', 'groupId': 'OG006', 'lowerLimit': '64.50', 'upperLimit': '544.00'}]}]}, {'title': 'CD4-IL-2, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '226.00', 'groupId': 'OG000', 'lowerLimit': '51.00', 'upperLimit': '574.00'}, {'value': '289.50', 'groupId': 'OG001', 'lowerLimit': '48.00', 'upperLimit': '729.50'}, {'value': '152.00', 'groupId': 'OG002', 'lowerLimit': '-45.50', 'upperLimit': '648.50'}, {'value': '225.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '442.00'}, {'value': '369.50', 'groupId': 'OG004', 'lowerLimit': '-38.00', 'upperLimit': '645.00'}, {'value': '242.00', 'groupId': 'OG005', 'lowerLimit': '120.00', 'upperLimit': '668.00'}, {'value': '158.50', 'groupId': 'OG006', 'lowerLimit': '-90.00', 'upperLimit': '523.00'}]}]}, {'title': 'CD4-IL2, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '227.00', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '547.00'}, {'value': '401.00', 'groupId': 'OG001', 'lowerLimit': '170.50', 'upperLimit': '644.00'}, {'value': '297.00', 'groupId': 'OG002', 'lowerLimit': '15.00', 'upperLimit': '549.00'}, {'value': '117.00', 'groupId': 'OG003', 'lowerLimit': '-64.50', 'upperLimit': '459.00'}, {'value': '400.50', 'groupId': 'OG004', 'lowerLimit': '132.00', 'upperLimit': '789.00'}, {'value': '518.00', 'groupId': 'OG005', 'lowerLimit': '224.00', 'upperLimit': '701.00'}, {'value': '257.00', 'groupId': 'OG006', 'lowerLimit': '150.00', 'upperLimit': '499.00'}]}]}, {'title': 'CD4-IL-2, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '363.50', 'groupId': 'OG000', 'lowerLimit': '57.00', 'upperLimit': '613.00'}, {'value': '285.00', 'groupId': 'OG001', 'lowerLimit': '58.00', 'upperLimit': '540.00'}, {'value': '294.50', 'groupId': 'OG002', 'lowerLimit': '158.00', 'upperLimit': '457.50'}, {'value': '359.00', 'groupId': 'OG003', 'lowerLimit': '180.00', 'upperLimit': '656.00'}, {'value': '648.00', 'groupId': 'OG004', 'lowerLimit': '40.00', 'upperLimit': '970.00'}, {'value': '523.00', 'groupId': 'OG005', 'lowerLimit': '381.00', 'upperLimit': '629.00'}, {'value': '493.00', 'groupId': 'OG006', 'lowerLimit': '198.00', 'upperLimit': '766.50'}]}]}, {'title': 'CD4-TNF-α, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '324.00', 'groupId': 'OG000', 'lowerLimit': '50.00', 'upperLimit': '425.00'}, {'value': '221.50', 'groupId': 'OG001', 'lowerLimit': '41.00', 'upperLimit': '608.50'}, {'value': '194.00', 'groupId': 'OG002', 'lowerLimit': '70.50', 'upperLimit': '550.00'}, {'value': '122.00', 'groupId': 'OG003', 'lowerLimit': '-68.00', 'upperLimit': '501.00'}, {'value': '210.50', 'groupId': 'OG004', 'lowerLimit': '-61.00', 'upperLimit': '423.00'}, {'value': '194.00', 'groupId': 'OG005', 'lowerLimit': '-33.00', 'upperLimit': '469.00'}, {'value': '140.50', 'groupId': 'OG006', 'lowerLimit': '-42.00', 'upperLimit': '540.50'}]}]}, {'title': 'CD4-TNF-α, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '293.00', 'groupId': 'OG000', 'lowerLimit': '150.00', 'upperLimit': '412.00'}, {'value': '282.50', 'groupId': 'OG001', 'lowerLimit': '164.00', 'upperLimit': '610.50'}, {'value': '259.00', 'groupId': 'OG002', 'lowerLimit': '12.00', 'upperLimit': '648.00'}, {'value': '142.50', 'groupId': 'OG003', 'lowerLimit': '-17.00', 'upperLimit': '430.00'}, {'value': '470.50', 'groupId': 'OG004', 'lowerLimit': '233.00', 'upperLimit': '795.00'}, {'value': '156.50', 'groupId': 'OG005', 'lowerLimit': '31.00', 'upperLimit': '937.00'}, {'value': '229.00', 'groupId': 'OG006', 'lowerLimit': '139.00', 'upperLimit': '340.00'}]}]}, {'title': 'CD4-TNF-α, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '291.50', 'groupId': 'OG000', 'lowerLimit': '177.00', 'upperLimit': '693.00'}, {'value': '157.00', 'groupId': 'OG001', 'lowerLimit': '-46.00', 'upperLimit': '538.00'}, {'value': '175.00', 'groupId': 'OG002', 'lowerLimit': '-20.50', 'upperLimit': '510.50'}, {'value': '239.00', 'groupId': 'OG003', 'lowerLimit': '114.00', 'upperLimit': '574.00'}, {'value': '454.00', 'groupId': 'OG004', 'lowerLimit': '234.00', 'upperLimit': '805.00'}, {'value': '313.00', 'groupId': 'OG005', 'lowerLimit': '239.00', 'upperLimit': '484.00'}, {'value': '252.50', 'groupId': 'OG006', 'lowerLimit': '106.00', 'upperLimit': '606.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Days 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.', 'unitOfMeasure': 'CD4+ T-cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'SECONDARY', 'title': 'Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'title': 'CD8-ALL DOUBLES, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '107.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '168.00'}, {'value': '62.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '186.00'}, {'value': '104.00', 'groupId': 'OG002', 'lowerLimit': '27.00', 'upperLimit': '292.00'}, {'value': '83.50', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '294.00'}, {'value': '83.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '302.00'}, {'value': '83.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '263.00'}, {'value': '12.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '124.00'}]}]}, {'title': 'CD8-ALL DOUBLES, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '104.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '320.00'}, {'value': '47.50', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '195.00'}, {'value': '148.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '218.00'}, {'value': '102.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '235.00'}, {'value': '34.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '313.00'}, {'value': '73.00', 'groupId': 'OG005', 'lowerLimit': '9.00', 'upperLimit': '347.00'}, {'value': '17.50', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '175.00'}]}]}, {'title': 'CD8-ALL DOUBLES, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '76.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '187.50'}, {'value': '19.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '151.00'}, {'value': '57.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '361.00'}, {'value': '51.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '378.00'}, {'value': '172.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '482.00'}, {'value': '98.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '304.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '265.00'}]}]}, {'title': 'CD8-ALL DOUBLES, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '438.50'}, {'value': '70.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '258.00'}, {'value': '167.50', 'groupId': 'OG002', 'lowerLimit': '43.00', 'upperLimit': '336.00'}, {'value': '147.50', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '301.00'}, {'value': '163.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '307.00'}, {'value': '173.50', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '434.00'}, {'value': '100.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '358.00'}]}]}, {'title': 'CD8-CD40L, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '54.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '58.50'}, {'value': '49.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '101.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '52.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '60.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '102.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '113.00'}]}]}, {'title': 'CD8-CD40L, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '81.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '3.50', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '60.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '190.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '95.50'}, {'value': '49.50', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '98.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '9.50'}]}]}, {'title': 'CD8-CD40L, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '52.00'}, {'value': '51.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '82.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '7.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '56.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '51.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '49.00'}]}]}, {'title': 'CD8-CD40L, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '100.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '49.00'}, {'value': '48.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 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subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'classes': [{'title': 'CD8-ALL DOUBLES, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-86.00', 'upperLimit': '143.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-99.00', 'upperLimit': 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'99.00'}, {'value': '-29.00', 'groupId': 'OG002', 'lowerLimit': '-50.00', 'upperLimit': '335.00'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '204.00'}, {'value': '-5.00', 'groupId': 'OG004', 'lowerLimit': '-188.00', 'upperLimit': '126.00'}, {'value': '94.00', 'groupId': 'OG005', 'lowerLimit': '-54.00', 'upperLimit': '386.00'}, {'value': '-1.50', 'groupId': 'OG006', 'lowerLimit': '-47.00', 'upperLimit': '344.00'}]}]}, {'title': 'CD8-CD40L, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-50.00', 'upperLimit': '1.00'}, 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'OG002', 'lowerLimit': '-18.00', 'upperLimit': '60.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-48.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-86.00', 'upperLimit': '62.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-76.00', 'upperLimit': '45.00'}]}]}, {'title': 'CD8-CD40L, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-48.00', 'upperLimit': '47.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-49.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': 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'upperLimit': '105.50'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-3.00', 'upperLimit': '50.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-50.00', 'upperLimit': '73.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-100.50', 'upperLimit': '135.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-42.00', 'upperLimit': '49.00'}]}]}, {'title': 'CD8-IFN-γ, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-63.00', 'upperLimit': '76.00'}, {'value': '-6.00', 'groupId': 'OG001', 'lowerLimit': '-96.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-159.00', 'upperLimit': 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'14.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '140.00'}, {'value': '-50.00', 'groupId': 'OG004', 'lowerLimit': '-96.00', 'upperLimit': '67.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-50.00', 'upperLimit': '120.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-124.00', 'upperLimit': '124.00'}]}]}, {'title': 'CD8-IL-2, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-103.00', 'upperLimit': '59.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-38.00', 'upperLimit': '47.00'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '-123.00', 'upperLimit': '66.50'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-98.00', 'upperLimit': '100.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-50.00', 'upperLimit': '118.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-80.00', 'upperLimit': '160.50'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-21.00', 'upperLimit': '96.00'}]}]}, {'title': 'CD8-IL-2, DAY 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-28.00', 'groupId': 'OG000', 'lowerLimit': '-151.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-38.00', 'upperLimit': '50.00'}, {'value': '-1.00', 'groupId': 'OG002', 'lowerLimit': '-205.00', 'upperLimit': '113.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '129.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-81.00', 'upperLimit': '38.00'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-60.00', 'upperLimit': '98.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-16.00', 'upperLimit': '78.50'}]}]}, {'title': 'CD8-IL-2, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-69.50', 'groupId': 'OG000', 'lowerLimit': '-106.00', 'upperLimit': '97.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-69.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-46.00', 'upperLimit': '247.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-67.00', 'upperLimit': '112.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-13.00', 'upperLimit': '98.00'}, {'value': '46.00', 'groupId': 'OG005', 'lowerLimit': '-102.00', 'upperLimit': '292.00'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '-45.00', 'upperLimit': '147.00'}]}]}, {'title': 'CD8-TNF-α, DAY 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '-99.00', 'upperLimit': '99.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-97.00', 'upperLimit': '47.00'}, {'value': '23.00', 'groupId': 'OG002', 'lowerLimit': '-49.50', 'upperLimit': '121.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': 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'upperLimit': '247.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-49.00', 'upperLimit': '47.00'}, {'value': '-24.50', 'groupId': 'OG005', 'lowerLimit': '-127.50', 'upperLimit': '114.50'}, {'value': '0.00', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '47.00'}]}]}, {'title': 'CD8-TNF-α, DAY 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-99.00', 'upperLimit': '47.00'}, {'value': '48.00', 'groupId': 'OG001', 'lowerLimit': '-69.00', 'upperLimit': '159.00'}, {'value': '74.00', 'groupId': 'OG002', 'lowerLimit': '-7.00', 'upperLimit': '289.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-52.00', 'upperLimit': '255.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-62.00', 'upperLimit': '149.00'}, {'value': '99.00', 'groupId': 'OG005', 'lowerLimit': '-34.00', 'upperLimit': '243.00'}, {'value': '24.00', 'groupId': 'OG006', 'lowerLimit': '-95.00', 'upperLimit': '120.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Days 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.', 'unitOfMeasure': 'CD8+ T-cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '77.8'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '50.2'}, {'value': '31.0', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '45.1'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '26.2'}, {'value': '63.1', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '87.9'}, {'value': '38.0', 'groupId': 'OG005', 'lowerLimit': '26.7', 'upperLimit': '54.1'}, {'value': '26.0', 'groupId': 'OG006', 'lowerLimit': '20.0', 'upperLimit': '34.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000', 'lowerLimit': '31.8', 'upperLimit': '77.4'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '86.7'}, {'value': '51.1', 'groupId': 'OG002', 'lowerLimit': '32.8', 'upperLimit': '79.5'}, {'value': '32.2', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '47.5'}, {'value': '71.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '100.7'}, {'value': '44.0', 'groupId': 'OG005', 'lowerLimit': '30.3', 'upperLimit': '64.0'}, {'value': '28.3', 'groupId': 'OG006', 'lowerLimit': '18.9', 'upperLimit': '42.4'}, {'value': '103.0', 'groupId': 'OG007', 'lowerLimit': '63.3', 'upperLimit': '167.5'}, {'value': '41.3', 'groupId': 'OG008', 'lowerLimit': '27.1', 'upperLimit': '62.7'}, {'value': '41.9', 'groupId': 'OG009', 'lowerLimit': '23.7', 'upperLimit': '74.1'}, {'value': '21.4', 'groupId': 'OG010', 'lowerLimit': '14.5', 'upperLimit': '31.6'}, {'value': '108.1', 'groupId': 'OG011', 'lowerLimit': '69.4', 'upperLimit': '168.5'}, {'value': '62.5', 'groupId': 'OG012', 'lowerLimit': '40.9', 'upperLimit': '95.3'}, {'value': '54.9', 'groupId': 'OG013', 'lowerLimit': '37.4', 'upperLimit': '80.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor for Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '9.0'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '6.8'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '6.4'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '3.7'}, {'value': '8.3', 'groupId': 'OG004', 'lowerLimit': '5.8', 'upperLimit': '11.9'}, {'value': '4.9', 'groupId': 'OG005', 'lowerLimit': '3.4', 'upperLimit': '7.2'}, {'value': '3.7', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '4.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor for Influenza A Subtype H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '8.2'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '13.5'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '13.6'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '6.4'}, {'value': '10.5', 'groupId': 'OG004', 'lowerLimit': '7.0', 'upperLimit': '15.6'}, {'value': '6.4', 'groupId': 'OG005', 'lowerLimit': '4.3', 'upperLimit': '9.6'}, {'value': '4.3', 'groupId': 'OG006', 'lowerLimit': '2.8', 'upperLimit': '6.4'}, {'value': '11.9', 'groupId': 'OG007', 'lowerLimit': '6.4', 'upperLimit': '21.9'}, {'value': '5.5', 'groupId': 'OG008', 'lowerLimit': '3.5', 'upperLimit': '8.6'}, {'value': '5.6', 'groupId': 'OG009', 'lowerLimit': '3.2', 'upperLimit': '9.6'}, {'value': '2.8', 'groupId': 'OG010', 'lowerLimit': '1.9', 'upperLimit': '4.2'}, {'value': '11.2', 'groupId': 'OG011', 'lowerLimit': '5.9', 'upperLimit': '21.1'}, {'value': '2.0', 'groupId': 'OG012', 'lowerLimit': '1.3', 'upperLimit': '3.2'}, {'value': '5.4', 'groupId': 'OG013', 'lowerLimit': '3.0', 'upperLimit': '9.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.', 'unitOfMeasure': 'Fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '51', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected Subjects Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}, {'value': '16', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Seroprotection Power Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '9', 'groupId': 'OG012'}, {'value': '10', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Seroprotection Power Against H9N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '21', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}, {'value': '16', 'groupId': 'OG012'}, {'value': '15', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Pain, Dose 1', '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'}]}]}, {'title': 'Any Redness (mm), Dose 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Redness (mm), Dose 1', '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'}]}]}, {'title': 'Any Swelling (mm), Dose 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Swelling (mm), Dose 1', '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'}]}]}, {'title': 'Any Pain, Dose 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Pain, Dose 2', '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'}]}]}, {'title': 'Any Redness (mm), Dose 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Redness (mm), Dose 2', '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'}]}]}, {'title': 'Any Swelling (mm), Dose 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Swelling (mm), Dose 2', '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'}]}]}, {'title': 'Any Pain, Across doses', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Pain, Across doses', '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'}]}]}, {'title': 'Any Redness (mm), Across doses', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Redness (mm), Across doses', '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'}]}]}, {'title': 'Any Swelling (mm), Across doses', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Swelling (mm), Across doses', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Pain', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Redness (mm)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Redness (mm)', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Swelling (mm)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Swelling (mm)', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'classes': [{'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Arthralgia', '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'}]}]}, {'title': 'Related Arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Fatigue', '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'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Temperature (Axillary) (°C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Temperature (Axillary) (°C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Related Temperature (Axillary) (°C)', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Headache', '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'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Myalgia', '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'}]}]}, {'title': 'Related Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Shivering', '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'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Any Sweating', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Sweating', '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'}]}]}, {'title': 'Related Sweating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-days (Day 0-3) post Dose 1', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'classes': [{'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Arthralgia', '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'}]}]}, {'title': 'Related Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Fatigue', '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'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Any Temperature (Axillary) (°C)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Temperature (Axillary) (°C)', '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'}]}]}, {'title': 'Related Temperature (Axillary) (°C)', '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'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Headache', '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'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Myalgia', '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'}]}]}, {'title': 'Related Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Shivering', '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'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Any Sweating', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Sweating', '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'}]}]}, {'title': 'Related Sweating', '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': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-days post Dose 2 (Days 21-24)', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '55', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG001', 'title': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG002', 'title': 'SB218352_4 Group', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG003', 'title': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG004', 'title': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG005', 'title': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'OG006', 'title': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'classes': [{'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Arthralgia', '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'}]}]}, {'title': 'Related Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Fatigue', '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'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Temperature (Axillary) (°C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Temperature (Axillary) (°C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Related Temperature (Axillary) (°C)', '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': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Headache', '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'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Myalgia', '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'}]}]}, {'title': 'Related Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Shivering', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '1', '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'}]}]}, {'title': 'Any Sweating', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Grade 3 Sweating', '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'}]}]}, {'title': 'Related Sweating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4-Days (Day 0-3) across doses 1 and 2', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'Any Arthralgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Arthralgia', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Arthralgia', '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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Fatigue', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Temperature', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Temperature', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Temperature', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Headache', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Myalgia', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Myalgia', 'categories': [{'measurements': [{'value': '1', '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': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Shivering', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Shivering', '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': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Any Sweating', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 Sweating', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related Sweating', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'Any unsolicited AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 unsolicited AEs', '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': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Related unsolicited AEs', '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'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)', '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 analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'Any SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '22', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '26', 'groupId': 'OG012'}, {'value': '24', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}]}, {'title': 'Grade 3 SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Related SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}]}], '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': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30-day post Dose 3 (Days 365-394)', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort (TVc) of Subset 2, which included all vaccinated subjects (for whom the diary card was available).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Antibody Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'SPR, Day 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}]}]}, {'title': 'SPR, Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '17', 'groupId': 'OG012'}, {'value': '16', 'groupId': 'OG013'}]}]}, {'title': 'SCR, Day 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}]}]}, {'title': 'SCR, Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 189 and 365', 'description': 'Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for Influenza A Subtype H9N2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'SB218352_15 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG001', 'title': 'SB218352_8 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG002', 'title': 'SB218352_4 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG003', 'title': 'SB218352_2 Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG004', 'title': 'SB218352_8AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG005', 'title': 'SB218352_4AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG006', 'title': 'SB218352_2AL Subset 1', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.'}, {'id': 'OG007', 'title': 'SB218352_15 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG008', 'title': 'SB218352_8 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG009', 'title': 'SB218352_4 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG010', 'title': 'SB218352_2 Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG011', 'title': 'SB218352_8AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG012', 'title': 'SB218352_4AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}, {'id': 'OG013', 'title': 'SB218352_2AL Subset 2', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.'}], 'classes': [{'title': 'SCF, Day 189', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '25', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.5'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '5.2'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '6.5'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '3.1'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '5.0'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '2.1', 'upperLimit': '4.9'}, {'value': '1.8', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '2.5'}, {'value': '3.3', 'groupId': 'OG007', 'lowerLimit': '1.8', 'upperLimit': '6.1'}, {'value': '2.7', 'groupId': 'OG008', 'lowerLimit': '1.5', 'upperLimit': '4.9'}, {'value': '2.1', 'groupId': 'OG009', 'lowerLimit': '1.1', 'upperLimit': '4.1'}, {'value': '1.5', 'groupId': 'OG010', 'lowerLimit': '1.1', 'upperLimit': '1.9'}, {'value': '5.8', 'groupId': 'OG011', 'lowerLimit': '3.4', 'upperLimit': '10.0'}, {'value': '2.2', 'groupId': 'OG012', 'lowerLimit': '1.3', 'upperLimit': '3.8'}, {'value': '1.7', 'groupId': 'OG013', 'lowerLimit': '1.1', 'upperLimit': '2.8'}]}]}, {'title': 'SCF, Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '20', 'groupId': 'OG010'}, {'value': '23', 'groupId': 'OG011'}, {'value': '24', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.6'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '8.5'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '7.4'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '3.0'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '6.1'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '4.2'}, {'value': '2.1', 'groupId': 'OG006', 'lowerLimit': '1.4', 'upperLimit': '3.1'}, {'value': '11.9', 'groupId': 'OG007', 'lowerLimit': '6.4', 'upperLimit': '21.9'}, {'value': '5.5', 'groupId': 'OG008', 'lowerLimit': '3.5', 'upperLimit': '8.6'}, {'value': '5.6', 'groupId': 'OG009', 'lowerLimit': '3.2', 'upperLimit': '9.6'}, {'value': '2.8', 'groupId': 'OG010', 'lowerLimit': '1.9', 'upperLimit': '4.2'}, {'value': '11.2', 'groupId': 'OG011', 'lowerLimit': '5.9', 'upperLimit': '21.1'}, {'value': '7.5', 'groupId': 'OG012', 'lowerLimit': '4.9', 'upperLimit': '11.5'}, {'value': '5.4', 'groupId': 'OG013', 'lowerLimit': '3.0', 'upperLimit': '9.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 189 and 365', 'description': 'SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'FG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}], 'periods': [{'title': 'Study Part I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '55'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '55'}, {'groupId': 'FG006', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}, {'title': 'Study Part II for Subset 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Study Part II for Subset 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After Part I, the core study (study period from Visit 1 on Day 0 up to the phone contact on Day 51), the enrolled subjects were stratified into Subset 1 (Part II - Visit 5 on Day 189 to study conclusion, i.e ., Visit 7 on Day 365) or Subset 2 (Part II - Visit 6 on Day 365 to study conclusion, i.e ., phone contact on Day 395).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}, {'value': '385', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'SB218352_15 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG001', 'title': 'SB218352_8 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG002', 'title': 'SB218352_4 Group:', 'description': 'Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG003', 'title': 'SB218352_2 Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG004', 'title': 'SB218352_8AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG005', 'title': 'SB218352_4AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.'}, {'id': 'BG006', 'title': 'SB218352_2AL Group:', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '5.11', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '5.66', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '5.77', 'groupId': 'BG002'}, {'value': '69.1', 'spread': '5.94', 'groupId': 'BG003'}, {'value': '68.4', 'spread': '5.92', 'groupId': 'BG004'}, {'value': '68.4', 'spread': '6.31', 'groupId': 'BG005'}, {'value': '69.8', 'spread': '5.91', 'groupId': 'BG006'}, {'value': '68.9', 'spread': '5.80', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}, {'value': '212', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '173', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Arabic/North African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'White-Caucasian', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '55', 'groupId': 'BG006'}, {'value': '384', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2006-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2006-02-16', 'resultsFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-06', 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer'}, {'measure': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer'}, {'measure': 'Seroconversion Factor for Influenza A Subtype H9N2', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.'}, {'measure': 'Seroconversion Factor for Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.'}, {'measure': 'Number of Seroprotected Subjects Against H9N2', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.'}, {'measure': 'Number of Seroprotected Subjects Against H9N2', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.'}, {'measure': 'Number of Subjects With Seroprotection Power Against H9N2', 'timeFrame': 'At Day 10 post Dose 1', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.'}, {'measure': 'Number of Subjects With Seroprotection Power Against H9N2', 'timeFrame': 'At Day 21 post Dose 1', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.'}, {'measure': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).'}, {'measure': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer'}, {'measure': 'Number of Seroconverted Subjects Against Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \\< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer'}, {'measure': 'Seroconversion Factor for Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.'}, {'measure': 'Seroconversion Factor for Influenza A Subtype H9N2', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.'}, {'measure': 'Number of Seroprotected Subjects Against H9N2', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.'}, {'measure': 'Number of Seroprotected Subjects Against H9N2', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.'}, {'measure': 'Number of Subjects With Seroprotection Power Against H9N2', 'timeFrame': 'At Day 21 post Dose 2 (Day 42)', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.'}, {'measure': 'Number of Subjects With Seroprotection Power Against H9N2', 'timeFrame': 'At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)', 'description': 'Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \\< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-days (Day 0-30) post vaccination', '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': 'From Day 0 to Day 51', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).'}, {'measure': 'Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells', 'timeFrame': 'At Days 0, 10, 21 and 42 post vaccination', 'description': 'Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).'}, {'measure': 'Frequency of Antigen-specific CD4 T-cells', 'timeFrame': 'At Days 0, 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).'}, {'measure': 'Cytokine-positive CD4 T-cells Frequency', 'timeFrame': 'At Days 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.'}, {'measure': 'Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells', 'timeFrame': 'At Days 0, 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).'}, {'measure': 'Frequency of Antigen-specific CD8 T-cells', 'timeFrame': 'At Days 0, 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).'}, {'measure': 'Cytokine-positive CD8 T-cells Frequency', 'timeFrame': 'At Days 10, 21 and 42 post-vaccination', 'description': 'Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-days (Day 0-3) post Dose 1', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-days post Dose 2 (Days 21-24)', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4-Days (Day 0-3) across doses 1 and 2', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, fever \\[defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)\\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.'}, {'measure': 'Number of Subjects With Unsolicited AEs', 'timeFrame': 'During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)', '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 SAEs', 'timeFrame': 'Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).'}, {'measure': 'Number of Subjects With Any SAEs', 'timeFrame': 'Up to 30-day post Dose 3 (Days 365-394)', 'description': 'A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.'}, {'measure': 'Number of Subjects With Antibody Persistence', 'timeFrame': 'At Days 189 and 365', 'description': 'Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.'}, {'measure': 'Seroconversion Factor (SCF) for Influenza A Subtype H9N2.', 'timeFrame': 'At Days 189 and 365', 'description': 'SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.'}]}, 'conditionsModule': {'keywords': ['prophylaxis of pandemic influenza'], 'conditions': ['Influenza', 'Influenza Vaccines']}, 'referencesModule': {'availIpds': [{'id': '102499', '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': '102499', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102499', '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': '102499', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102499', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol\n* A male or female aged over 60 years at the time of vaccination.\n* Written informed consent obtained from the subject.\n\nExclusion criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.\n* Participation in an earlier study with a candidate pandemic H9N2 vaccine.\n* Acute disease at the time of enrolment.\n* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Drug and/or alcohol dependency.'}, 'identificationModule': {'nctId': 'NCT00306995', 'briefTitle': 'Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age', 'orgStudyIdInfo': {'id': '102499'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SB218352_15 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_15']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_8 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_8']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_4 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_4']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_2 Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_2']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_8AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_8AL']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_4AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_4AL']}, {'type': 'EXPERIMENTAL', 'label': 'SB218352_2AL Group', 'description': 'Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.', 'interventionNames': ['Biological: SB218352_2AL']}], 'interventions': [{'name': 'SB218352_15', 'type': 'BIOLOGICAL', 'description': 'Non-adjuvanted pandemic influenza A formulation 1 vaccine', 'armGroupLabels': ['SB218352_15 Group']}, {'name': 'SB218352_8', 'type': 'BIOLOGICAL', 'description': 'Non-adjuvanted pandemic influenza A formulation 2 vaccine', 'armGroupLabels': ['SB218352_8 Group']}, {'name': 'SB218352_4', 'type': 'BIOLOGICAL', 'description': 'Non-adjuvanted pandemic influenza A formulation 3 vaccine', 'armGroupLabels': ['SB218352_4 Group']}, {'name': 'SB218352_2', 'type': 'BIOLOGICAL', 'description': 'Non-adjuvanted pandemic influenza A formulation 4 vaccine', 'armGroupLabels': ['SB218352_2 Group']}, {'name': 'SB218352_8AL', 'type': 'BIOLOGICAL', 'description': 'Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine', 'armGroupLabels': ['SB218352_8AL Group']}, {'name': 'SB218352_4AL', 'type': 'BIOLOGICAL', 'description': 'Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine', 'armGroupLabels': ['SB218352_4AL Group']}, {'name': 'SB218352_2AL', 'type': 'BIOLOGICAL', 'description': 'Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine', 'armGroupLabels': ['SB218352_2AL Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03238', 'city': 'Finsterwalde', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.63388, 'lon': 13.70662}}, {'zip': '14669', 'city': 'Ketzin', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.47809, 'lon': 12.8453}}, {'zip': '21255', 'city': 'Tostedt', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK 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