Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT00560066
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2007-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
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': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Because cTIV was not available, the second part of the study was not performed. In addition, as deviations from protocol procedures and GCP were identified at some sites, data collected for this study were not used to support licensure of cTIV.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study period (day 1 to day 181).', 'description': 'All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Egg-derived Vaccine (TIV)', 'description': 'Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine', 'otherNumAtRisk': 396, 'otherNumAffected': 204, 'seriousNumAtRisk': 396, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Cell Culture-derived Vaccine (cTIV)', 'description': 'Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine', 'otherNumAtRisk': 1001, 'otherNumAffected': 568, 'seriousNumAtRisk': 1001, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 185}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 330}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 90}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 76}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 150}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 198}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 56}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Chest Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden Hearing Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Optic Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral Caruncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1001, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'Pain (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Chills (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Malaise (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Headache (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Sweating (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (N=66,226,7,11)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Fever (≥38 °C)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 through Day 7 post-vaccination', 'description': 'Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.'}, {'type': 'SECONDARY', 'title': 'Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'Pain (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Chills (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Malaise (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Headache (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Sweating (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (N=220,484,98,263)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Fever (≥38 °C)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 through Day 7 post-vaccination', 'description': 'Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.'}, {'type': 'SECONDARY', 'title': 'Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'A/H1N1 (Day 1)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '65'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '62'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '61'}, {'value': '56', 'groupId': 'OG003', 'lowerLimit': '35', 'upperLimit': '76'}]}]}, {'title': 'A/H1N1 (Day 22)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '98'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '86', 'upperLimit': '100'}]}]}, {'title': 'A/H3N2 (Day 1)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '63'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '55'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '59', 'upperLimit': '93'}, {'value': '64', 'groupId': 'OG003', 'lowerLimit': '43', 'upperLimit': '82'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '99'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '93'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '86', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG003', 'lowerLimit': '69', 'upperLimit': '97'}]}]}, {'title': 'B (Day 1)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '21'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '61'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '49'}]}]}, {'title': 'B (Day 22)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '84'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '71'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '46', 'upperLimit': '85'}, {'value': '48', 'groupId': 'OG003', 'lowerLimit': '28', 'upperLimit': '69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before vaccination (Day 1) and three weeks after vaccination (Day 22)', 'description': 'Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \\>70% (≥18 to ≤60 years), or \\>60% (≥61 years).', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set \\[FAS\\]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)'}, {'type': 'SECONDARY', 'title': 'Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '72'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '74'}, {'value': '72', 'groupId': 'OG002', 'lowerLimit': '51', 'upperLimit': '88'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '39', 'upperLimit': '79'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '71'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '65'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '61'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '61'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '64'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '50'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '45'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '41'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post-vaccination (Day 22)', 'description': 'Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer \\<10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be \\>40% (≥18 to ≤60 years) or \\>30% (≥61 years).', 'unitOfMeasure': 'Percentages of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'A/H1N1 (Day 1)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '49'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '46'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '33'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '17', 'upperLimit': '51'}]}]}, {'title': 'A/H1N1 (Day 22)', 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '443'}, {'value': '308', 'groupId': 'OG001', 'lowerLimit': '246', 'upperLimit': '386'}, {'value': '132', 'groupId': 'OG002', 'lowerLimit': '87', 'upperLimit': '199'}, {'value': '158', 'groupId': 'OG003', 'lowerLimit': '104', 'upperLimit': '238'}]}]}, {'title': 'A/H3N2 (Day 1)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '40'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '38'}, {'value': '56', 'groupId': 'OG002', 'lowerLimit': '32', 'upperLimit': '97'}, {'value': '41', 'groupId': 'OG003', 'lowerLimit': '23', 'upperLimit': '71'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000', 'lowerLimit': '179', 'upperLimit': '281'}, {'value': '156', 'groupId': 'OG001', 'lowerLimit': '125', 'upperLimit': '196'}, {'value': '174', 'groupId': 'OG002', 'lowerLimit': '112', 'upperLimit': '271'}, {'value': '145', 'groupId': 'OG003', 'lowerLimit': '93', 'upperLimit': '226'}]}]}, {'title': 'B (Day 1)', 'categories': [{'measurements': [{'value': '9.35', 'groupId': 'OG000', 'lowerLimit': '7.96', 'upperLimit': '11'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9.24', 'upperLimit': '13'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '31'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '8.86', 'upperLimit': '21'}]}]}, {'title': 'B (Day 22)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '66'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '47'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '72'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '44'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (Day 1) and three weeks after vaccination (Day 22)', 'description': 'Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG001', 'title': 'cTIV (Adults)', 'description': 'Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine'}, {'id': 'OG002', 'title': 'TIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine'}, {'id': 'OG003', 'title': 'cTIV (Elderly)', 'description': 'Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '9.65', 'groupId': 'OG000', 'lowerLimit': '7.03', 'upperLimit': '13'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '6.55', 'upperLimit': '12'}, {'value': '6.96', 'groupId': 'OG002', 'lowerLimit': '3.98', 'upperLimit': '12'}, {'value': '5.35', 'groupId': 'OG003', 'lowerLimit': '3.06', 'upperLimit': '9.37'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '7.35', 'groupId': 'OG000', 'lowerLimit': '5.62', 'upperLimit': '9.61'}, {'value': '5.32', 'groupId': 'OG001', 'lowerLimit': '4.07', 'upperLimit': '6.95'}, {'value': '3.12', 'groupId': 'OG002', 'lowerLimit': '1.76', 'upperLimit': '5.51'}, {'value': '3.58', 'groupId': 'OG003', 'lowerLimit': '2.02', 'upperLimit': '6.33'}]}]}, {'title': 'B', 'categories': [{'measurements': [{'value': '5.88', 'groupId': 'OG000', 'lowerLimit': '4.62', 'upperLimit': '7.49'}, {'value': '3.57', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.54'}, {'value': '2.17', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '3.64'}, {'value': '1.92', 'groupId': 'OG003', 'lowerLimit': '1.15', 'upperLimit': '3.21'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Three weeks post-vaccination (Day 22)', 'description': 'Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is \\>2.5 (≥18 to ≤60 years) or \\>2.0 (≥61 Years).', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '1001', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Egg-derived Vaccine (TIV)', 'description': 'Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine'}, {'id': 'OG001', 'title': 'Cell Culture-derived Vaccine (cTIV)', 'description': 'Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine'}], 'classes': [{'title': 'Any reaction - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any reaction - None', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}]}, {'title': 'Any reaction - Other than severe', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '495', 'groupId': 'OG001'}]}]}, {'title': 'Any reaction - Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Local reaction - Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Local reaction - None', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}]}, {'title': 'Local reaction - Other than severe', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}]}, {'title': 'Local reaction - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Systemic reaction - Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Systemic reaction - None', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}]}]}, {'title': 'Systemic reaction - Other than severe', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}]}, {'title': 'Systemic reaction - Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to and including Day 7 post-vaccination', 'description': 'Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Egg-derived Vaccine (TIV)', 'description': 'Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.'}, {'id': 'FG001', 'title': 'Cell Culture-derived Vaccine (cTIV)', 'description': 'Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '1002'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '980'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Missing primary reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 17 centres in Germany.', 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'BG000'}, {'value': '1002', 'groupId': 'BG001'}, {'value': '1398', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Egg-derived Vaccine (TIV)', 'description': 'Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine'}, {'id': 'BG001', 'title': 'Cell Culture-derived Vaccine (cTIV)', 'description': 'Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '17.3', 'groupId': 'BG000'}, {'value': '48.7', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '533', 'groupId': 'BG001'}, {'value': '739', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '659', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2011-12-13', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2007-11-16', 'dispFirstSubmitQcDate': '2011-12-13', 'resultsFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2007-11-16', 'dispFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-17', 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV', 'timeFrame': 'From Day 1 up to and including Day 7 post-vaccination', 'description': 'Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.'}], 'secondaryOutcomes': [{'measure': 'Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV', 'timeFrame': 'From Day 1 through Day 7 post-vaccination', 'description': 'Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).'}, {'measure': 'Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV', 'timeFrame': 'From Day 1 through Day 7 post-vaccination', 'description': 'Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.'}, {'measure': 'Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV', 'timeFrame': 'Before vaccination (Day 1) and three weeks after vaccination (Day 22)', 'description': 'Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \\>70% (≥18 to ≤60 years), or \\>60% (≥61 years).'}, {'measure': 'Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV', 'timeFrame': 'Three weeks post-vaccination (Day 22)', 'description': 'Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer \\<10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be \\>40% (≥18 to ≤60 years) or \\>30% (≥61 years).'}, {'measure': 'Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV', 'timeFrame': 'Before vaccination (Day 1) and three weeks after vaccination (Day 22)', 'description': 'Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).'}, {'measure': 'Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV', 'timeFrame': 'Three weeks post-vaccination (Day 22)', 'description': 'Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is \\>2.5 (≥18 to ≤60 years) or \\>2.0 (≥61 Years).'}]}, 'conditionsModule': {'keywords': ['influenza', 'vaccine'], 'conditions': ['Seasonal Influenza', 'Vaccine']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;\n2. Able to comply with all study procedures and requirements.\n\nExclusion Criteria:\n\n1. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;\n2. Fatal prognosis of an underlying medical condition (\\<12 months life expectancy);\n3. History of Guillain-Barre syndrome;\n4. Bleeding diathesis or receiving anticoagulants of the coumarin type;\n5. Hospitalization or residence in a nursing care facility;\n6. Planned to receive seasonal influenza vaccine outside of this study;\n7. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;\n8. Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;\n9. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;\n10. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;\n11. Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.'}, 'identificationModule': {'nctId': 'NCT00560066', 'briefTitle': 'Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions', 'orgStudyIdInfo': {'id': 'V58P14'}, 'secondaryIdInfos': [{'id': '2007-002872-32'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cTIV', 'description': 'Subjects received one vaccination of cell culture-derived influenza vaccine', 'interventionNames': ['Biological: Cell-derived influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIV', 'description': 'Subjects received one vaccination of egg-derived influenza vaccine', 'interventionNames': ['Biological: Egg-derived influenza vaccine']}], 'interventions': [{'name': 'Cell-derived influenza vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of 0.5 mL in the deltoid region of the non-dominant arm', 'armGroupLabels': ['cTIV']}, {'name': 'Egg-derived influenza vaccine', 'type': 'BIOLOGICAL', 'description': '1 dose of 0.5 mL in the deltoid region of the non-dominant arm', 'armGroupLabels': ['TIV']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Balve', 'country': 'Germany', 'geoPoint': {'lat': 51.3315, 'lon': 7.86424}}, {'city': 'Duisberg', 'country': 'Germany'}, {'city': 'Garmisch-Partenkirchen', 'country': 'Germany', 'geoPoint': {'lat': 47.49209, 'lon': 11.09576}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Herborn', 'country': 'Germany', 'geoPoint': {'lat': 50.68135, 'lon': 8.30369}}, {'city': 'Illingen', 'country': 'Germany', 'geoPoint': {'lat': 49.37362, 'lon': 7.04758}}, {'city': 'Kiel', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Laufach', 'country': 'Germany', 'geoPoint': {'lat': 50.01667, 'lon': 9.3}}, {'city': 'Marburg', 'country': 'Germany', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Midlum', 'country': 'Germany', 'geoPoint': {'lat': 53.73135, 'lon': 8.61695}}, {'city': 'Olpe', 'country': 'Germany', 'geoPoint': {'lat': 51.02899, 'lon': 7.85139}}, {'city': 'Potsdam', 'country': 'Germany', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Unterschleissheim', 'country': 'Germany', 'geoPoint': {'lat': 48.28038, 'lon': 11.57684}}, {'city': 'Wiesbaden', 'country': 'Germany', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}