Viewing Study NCT01857206

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Ignite Creation Date: 2025-12-26 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
Study NCT ID: NCT01857206
Status: COMPLETED
Last Update Posted: 2014-12-05
First Post: 2013-05-16
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D005334', 'term': 'Fever'}], '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'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated.', 'description': 'For subjects aged ≥4 to ≤8 years not previously vaccinated AEs collected from day 1 to 7 and day 29 to 35. SAEs, medically attended AEs and NOCD till day 213 For subjects aged ≥4 to ≤8 years previously vaccinated and subjects aged ≥9 to ≤17 Years AEs were collected from day 1 to 7. SAEs, medically attended AEs and NOCD were collected till day 183', 'eventGroups': [{'id': 'EG000', 'title': 'TIVc(4-8Years )', 'description': 'Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.', 'otherNumAtRisk': 688, 'otherNumAffected': 545, 'seriousNumAtRisk': 688, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'TIVf(4-8Years )', 'description': 'Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.', 'otherNumAtRisk': 341, 'otherNumAffected': 267, 'seriousNumAtRisk': 341, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'TIVc(9-17Years )', 'description': 'Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.', 'otherNumAtRisk': 682, 'otherNumAffected': 489, 'seriousNumAtRisk': 682, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'TIVf(9-17Years )', 'description': 'Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.', 'otherNumAtRisk': 341, 'otherNumAffected': 220, 'seriousNumAtRisk': 341, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 109}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJECTION SITE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 433}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 211}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 385}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 159}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJECTION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 130}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 45}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 137}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 62}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'LYMPHADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ACUTE SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'APPENDICITIS PERFORATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'DENGUE FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PHARYNGOTONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'RESPIRATORY SYNCYTIAL VIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'SINUSITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ANIMAL BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ANIMAL SCRATCH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'LIGAMENT RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'MULTIPLE INJURIES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'RADIUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'CEREBELLAR ATAXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'VISUAL FIELD DEFECT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ADNEXAL TORSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 688, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 682, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 341, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '682', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TIVc (≥4 to ≤8 Years)', 'description': 'Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based 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[{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Swelling (AE)', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Erythema (AE)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Ecchymosis (AE)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Injection site Pain (AE)', 'categories': [{'measurements': [{'value': '384', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}, {'title': 'Any Systemic', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}, {'title': 'Chills (AE)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Nausea (AE)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia (AE)', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia (AE)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Headache (AE)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue (AE)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Loss of appetite (AE)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Malaise (AE)', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}]}, {'title': 'Sweating (AE)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Body Temperature (≥38°C) (AE)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '≥40°C (Other Indicator)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Prevention of pain and/or fever (Other Indicator)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Treatment of pain and/or fever (Other Indicator)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 7 after any vaccination', 'description': 'Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.'}, {'type': 'PRIMARY', 'title': 'Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '340', 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'Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'OG001', 'title': 'TIVf (≥4 to ≤8 Years)', 'description': 'Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'OG002', 'title': 'TIVc (≥9 to ≤17 Years)', 'description': 'Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'OG003', 'title': 'TIVf (≥9 to ≤17 Years)', 'description': 'Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, 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{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects', 'description': 'Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TIVc', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'FG001', 'title': 'TIVf', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1372'}, {'groupId': 'FG001', 'numSubjects': '683'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1359'}, {'groupId': 'FG001', 'numSubjects': '673'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'ADMINISTRATIVE REASON', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at a total of 34 centers in 5 countries: 18 sites in the US, 6 sites in Australia, 2 sites in New Zealand, 5 sites in the Philippines and 3 sites in Thailand.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1372', 'groupId': 'BG000'}, {'value': '683', 'groupId': 'BG001'}, {'value': '2055', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TIVc', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'BG001', 'title': 'TIVf', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.'}, {'id': 'BG002', 'title': 'TOTAL', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '703', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '1052', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '669', 'groupId': 'BG000'}, {'value': '334', 'groupId': 'BG001'}, {'value': '1003', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 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Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy subjects 4-17 years of age\n\nExclusion Criteria:\n\n* Subjects who are not healthy,\n* Subjects who are pregnant or breast feeding,\n* Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.'}, 'identificationModule': {'nctId': 'NCT01857206', 'briefTitle': 'Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.', 'orgStudyIdInfo': {'id': 'V58_31'}, 'secondaryIdInfos': [{'id': 'U1111-1139-9440', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIVc', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.', 'interventionNames': ['Biological: Mammalian cell based flu vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIVf', 'description': 'Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.', 'interventionNames': ['Biological: Egg based flu vaccine']}], 'interventions': [{'name': 'Mammalian cell based flu vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TIVc']}, {'name': 'Egg based flu vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['TIVf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': '320, Novartis Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '32081', 'city': 'Ponte Vedra', 'state': 'Florida', 'country': 'United States', 'facility': '312, Novartis Investigational Site', 'geoPoint': {'lat': 30.22746, 'lon': -81.38008}}, {'zip': '67010', 'city': 'Augusta', 'state': 'Kansas', 'country': 'United States', 'facility': '313, Novartis Investigational Site', 'geoPoint': {'lat': 37.68668, 'lon': -96.9767}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': '305, Novartis Investigational Site', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': '302, Novartis Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': '301, Novartis Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': '311, Novartis Investigational Site', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': '308, Novartis Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44121', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': '317, Novartis Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '74127', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': '309, Novartis Investigational Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': '314, Novartis Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29464', 'city': 'Mt. 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