Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT01374516
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2011-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}, {'id': 'D019595', 'term': 'Severe Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Unsolicited adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each vaccination. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 72 months).', 'description': 'Analysis were performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.', 'otherNumAtRisk': 1333, 'deathsNumAtRisk': 13915, 'otherNumAffected': 1038, 'seriousNumAtRisk': 13915, 'deathsNumAffected': 42, 'seriousNumAffected': 1765}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo vaccine; one each at 0, 6, and 12 months.', 'otherNumAtRisk': 664, 'deathsNumAtRisk': 6939, 'otherNumAffected': 515, 'seriousNumAtRisk': 6939, 'deathsNumAffected': 27, 'seriousNumAffected': 911}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 771, 'numAffected': 500}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 366, 'numAffected': 253}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 99, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 52, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1056, 'numAffected': 650}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 384, 'numAffected': 270}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 92, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 853, 'numAffected': 539}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 383, 'numAffected': 264}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 270, 'numAffected': 238}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 142, 'numAffected': 127}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 80, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 40, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 163, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 70, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 921, 'numAffected': 578}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 400, 'numAffected': 267}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1333, 'numEvents': 1385, 'numAffected': 753}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 652, 'numAffected': 388}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Anaemia Of Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Aplastic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Idiopathic Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Lymphoid Tissue Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Wolff-Parkinson-White Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Arteriovenous Malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Hereditary Spherocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Sickle Cell Trait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Tympanic Membrane Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Hypothalamo-Pituitary Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Keratoconus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abdominal Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Acute Abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Anal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Gastritis Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Inguinal Hernia, Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Intestinal Functional Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Malocclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 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'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Nasal Septum Deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Nasal Turbinate Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pulmonary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Respiratory Tract Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Status Asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Tonsillar Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Tonsillar Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Erythema Nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Henoch-Schonlein Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Hypertrophic Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Mechanical Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Rash Erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Skin Fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Subcutaneous Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Physical Assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Sexual Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Substance Use', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Victim Of Crime', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Victim Of Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Victim Of Sexual Abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abortion Induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Abortion Induced Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Caesarean Section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Obesity Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Scoliosis Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Umbilical Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}, {'term': 'Secondary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13915, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6939, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12574', 'groupId': 'OG000'}, {'value': '6261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.8', 'ciLowerLimit': '52.0', 'ciUpperLimit': '68.0', 'groupDescription': 'The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \\& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction (RT-PCR) and/or dengue non-structural (NS) protein 1 antigen enzyme-linked immunosorbent assay (ELISA). Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of symptomatic VCD cases were assessed in the Per-Protocol Analysis Set for Efficacy, defined as participants who had no protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13914', 'groupId': 'OG000'}, {'value': '6940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.7', 'ciLowerLimit': '58.7', 'ciUpperLimit': '69.8', 'groupDescription': 'The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included all participants who received at least 1 injection.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13914', 'groupId': 'OG000'}, {'value': '6940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.7', 'ciLowerLimit': '58.7', 'ciUpperLimit': '69.9', 'groupDescription': 'The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-injection 1 and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included participants who received at least 1 dose of study vaccine.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13506', 'groupId': 'OG000'}, {'value': '6765', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.9', 'ciLowerLimit': '54.7', 'ciUpperLimit': '68.0', 'groupDescription': 'The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-injection 2 and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of symptomatic VCD cases were assessed in the Other Efficacy Analysis Set, which included participants who received at least 2 doses of study vaccine.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12809', 'groupId': 'OG000'}, {'value': '6380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Due to Any of the 4 Serotypes: Any Grade', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade II', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to the end of study (up to 72 months)', 'description': 'Dengue hemorrhagic fever (DHF) cases were defined as number of participants with at least one symptomatic VCD episode meeting the 1997 WHO criteria. (a) Fever: acute onset, high (\\>= 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet \\<=100 x 109/L) and plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion (seen on CXR) and/or ascites and/ or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish a clinical diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhage.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': "Number of WHO dengue hemorrhagic fever cases were assessed in the Safety Analysis Set, which included all participants who received at least one dose of study vaccine. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic VCD Cases Meeting WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11063', 'groupId': 'OG000'}, {'value': '5430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Due to Any of the 4 Serotypes: Any Grade', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade II', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Due to Any of the 4 Serotypes: Grade IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)', 'description': 'The 1997 WHO criteria are: a) Fever: acute onset, high (\\>= 38°C) and continuous, for 2 to 7 days and (b) any of the following: thrombocytopenia (platelet \\<=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participant, usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of WHO dengue hemorrhagic fever cases were assessed in the Full Analysis Set for Surveillance Expansion Period, which included all participants who received at least 1 injection and accepted to be included in the Surveillance Expansion Period.'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12809', 'groupId': 'OG000'}, {'value': '6380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to the end of study (up to 72 months)', 'description': 'Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) requiring hospitalization.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': "Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13915', 'groupId': 'OG000'}, {'value': '6939', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to end of the study (up to 72 months)', 'description': 'Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) requiring hospitalization.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12809', 'groupId': 'OG000'}, {'value': '6380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to the end of study (up to 72 months)', 'description': 'The severity of VCD cases was assessed by an Independent Data monitoring Committee (IDMC) based on a medical review of cases and any of the following criteria:1) Platelet count \\<=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure \\<= 20 mmHg in a child, or hypotension \\[\\<= 90 mmHg\\] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by Glasgow Coma Scale (GCS) score 5) Liver impairment (AST \\>1000 IU/L or prothrombin time \\[PT\\] International normalized ratio \\[INR\\] \\>1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine \\>= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': "Number of clinically severe VCD cases were assessed in the Safety Analysis Set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11061', 'groupId': 'OG000'}, {'value': '5431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)', 'description': 'The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:-1) Platelet count \\<=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure \\<= 20 mmHg in a child, or hypotension \\[\\<= 90 mmHg\\] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST \\>1000 IU/L or PT INR \\>1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine \\>= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'populationDescription': "Number of clinically severe VCD cases were assessed in the Full Analysis Set for Surveillance Expansion Period. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Antibody Titers >=10 1/Dil Against Each Dengue Virus Serotype Before and Following Injection (Inj.) With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '643', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Subset of participants who received at least one dose of CYD Dengue vaccine.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subset of participants who received at least one dose of placebo vaccine.'}], 'classes': [{'title': 'Dengue virus Serotype 1: Pre-Inj.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '70.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 1: Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 1: Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 1; 1 year Post-Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 1; 5 year Post-Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1299', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}, {'value': '73.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 2; Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}, {'value': '75.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 2; Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}, {'value': '77.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 2; 1 year Post-Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1264', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}, {'value': '78.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 2; 5 year Post-Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}, {'value': '83.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 3; Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}, {'value': '75.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 3; Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '78.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 3; 1 year Post-Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1265', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 3; 5 year Post-Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000'}, {'value': '82.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 4; Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1295', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '67.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 4; Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 4; 1 year Post-Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1265', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue virus Serotype 4; 5 year Post-Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}, {'value': '78.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit [V] 07) and 60 months (Visit [V] 12) post-injection 3', 'description': 'Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (parental strains) were measured by the plaque reduction neutralization test in a pre-defined subset of participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Antibody titers against each dengue virus serotype strain were assessed in Full Analysis Set for Immunogenicity(FASI),which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose.Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1301', 'groupId': 'OG000'}, {'value': '643', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Subset of participants who received at least one dose of CYD Dengue vaccine.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subset of participants who received at least one dose of the placebo vaccine.'}], 'classes': [{'title': 'Dengue virus Serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '641', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '145'}, {'value': '119', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '142'}]}]}, {'title': 'Dengue virus Serotype 1; Post Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '638', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000', 'lowerLimit': '406', 'upperLimit': '517'}, {'value': '128', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '154'}]}]}, {'title': 'Dengue virus Serotype 1; Post Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '395', 'groupId': 'OG000', 'lowerLimit': '353', 'upperLimit': '441'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '145'}]}]}, {'title': 'Dengue virus Serotype 1; Year 1 Post Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1261', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000', 'lowerLimit': '234', 'upperLimit': '302'}, {'value': '146', 'groupId': 'OG001', 'lowerLimit': '121', 'upperLimit': '176'}]}]}, {'title': 'Dengue virus Serotype 1; Year 5 Post Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000', 'lowerLimit': '252', 'upperLimit': '321'}, {'value': '210', 'groupId': 'OG001', 'lowerLimit': '172', 'upperLimit': '255'}]}]}, {'title': 'Dengue virus Serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1299', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000', 'lowerLimit': '123', 'upperLimit': '156'}, {'value': '115', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '136'}]}]}, {'title': 'Dengue virus Serotype 2; Post Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000', 'lowerLimit': '566', 'upperLimit': '684'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '148'}]}]}, {'title': 'Dengue virus Serotype 2; Post Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '574', 'groupId': 'OG000', 'lowerLimit': '528', 'upperLimit': '624'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '109', 'upperLimit': '152'}]}]}, {'title': 'Dengue virus Serotype 2; Year 1 Post-Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1264', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000', 'lowerLimit': '336', 'upperLimit': '409'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '173'}]}]}, {'title': 'Dengue virus Serotype 2; Year 5 Post-Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000', 'lowerLimit': '269', 'upperLimit': '328'}, {'value': '201', 'groupId': 'OG001', 'lowerLimit': '168', 'upperLimit': '242'}]}]}, {'title': 'Dengue virus Serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '136'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '136'}]}]}, {'title': 'Dengue virus Serotype 3; Post Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '556', 'groupId': 'OG000', 'lowerLimit': '506', 'upperLimit': '610'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '139'}]}]}, {'title': 'Dengue virus Serotype 3; Post Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000', 'lowerLimit': '465', 'upperLimit': '555'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '147'}]}]}, {'title': 'Dengue virus Serotype 3; Year 1 Post Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1265', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000', 'lowerLimit': '263', 'upperLimit': '325'}, {'value': '137', 'groupId': 'OG001', 'lowerLimit': '114', 'upperLimit': '165'}]}]}, {'title': 'Dengue virus Serotype 3; Year 5 Post Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '346', 'groupId': 'OG000', 'lowerLimit': '313', 'upperLimit': '383'}, {'value': '224', 'groupId': 'OG001', 'lowerLimit': '185', 'upperLimit': '271'}]}]}, {'title': 'Dengue virus Serotype 4; Pre Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000', 'lowerLimit': '39.6', 'upperLimit': '48.0'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '44.7'}]}]}, {'title': 'Dengue virus Serotype 4; Post Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1295', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000', 'lowerLimit': '242', 'upperLimit': '281'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '35.5', 'upperLimit': '47.0'}]}]}, {'title': 'Dengue virus Serotype 4; Post Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1291', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '226', 'upperLimit': '258'}, {'value': '44.3', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '50.8'}]}]}, {'title': 'Dengue virus Serotype 4; Year 1 Post Inj. 3 (V 07)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1265', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000', 'lowerLimit': '161', 'upperLimit': '188'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '44.3', 'upperLimit': '59.8'}]}]}, {'title': 'Dengue virus Serotype 4; Year 5 Post Inj. 3 (V 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '508', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '156'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '63.4', 'upperLimit': '85.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3', 'description': 'Geometric mean titers for each of the 4 dengue virus serotypes (parental strains) were assessed using the plaque reduction neutralization test in a pre-defined subset of participants.', 'unitOfMeasure': 'Titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Antibody titers against each dengue virus serotype strain were assessed in FASI, which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here,'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1333', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Injection-site Pain (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '650', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (Post-any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (Post-any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Pain (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Pain (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Erythema (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Swelling (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1326', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Pain (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Pain (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Erythema (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Swelling (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Pain (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1279', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Pain (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1279', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Erythema (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1278', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Erythema (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1278', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site Swelling (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1279', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection-site Swelling (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1279', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each and any injection', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (9-11 years): Pain: incapacitating, unable to perform usual activities; Erythema and Swelling, \\>= 50 mm. Grade 3 Solicited injection site reactions (12-16 years): Pain: significant, prevents daily activity; Erythema and Swelling, \\>100 mm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Solicited injection site reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine and who were evaluated for reactogenicity. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1333', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Fever (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1318', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Headache (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '727', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '536', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '576', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia (Post any injection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1328', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1264', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1264', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Headache (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1324', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '528', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1324', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia (Post-injection 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1228', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1228', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Headache (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '273', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia (Post-injection 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1298', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Fever (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1215', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1215', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Headache (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '378', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Malaise (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '255', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia (Post-injection 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1277', 'groupId': 'OG000'}, {'value': '631', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after each and any injection', 'description': 'Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: \\>= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Solicited systemic reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine and who were evaluated for reactogenicity. Here, 'number analyzed' = participants with available data for specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}], 'periods': [{'title': 'Vaccination Phase (Up to 25 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13920'}, {'groupId': 'FG001', 'numSubjects': '6949'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13281'}, {'groupId': 'FG001', 'numSubjects': '6640'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}, {'groupId': 'FG001', 'numSubjects': '309'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '480'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Surveillance Expansion Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13281'}, {'groupId': 'FG001', 'numSubjects': '6640'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10932'}, {'groupId': 'FG001', 'numSubjects': '5387'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2349'}, {'groupId': 'FG001', 'numSubjects': '1253'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '386'}, {'groupId': 'FG001', 'numSubjects': '217'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1870'}, {'groupId': 'FG001', 'numSubjects': '986'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 08 June 2011 to 16 March 2012 at 5 clinical centers in Brazil, 9 in Colombia, 1 in Honduras, 5 in Mexico, and 2 in Puerto Rico.', 'preAssignmentDetails': 'A total of 20869 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13920', 'groupId': 'BG000'}, {'value': '6949', 'groupId': 'BG001'}, {'value': '20869', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants received 3 doses of placebo matched to vaccine; one each at 0, 6, and 12 months and were followed up to 60 months after last vaccination (or a total duration of up to 72 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '13920', 'groupId': 'BG000'}, {'value': '6949', 'groupId': 'BG001'}, {'value': '20869', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Age Continuous', 'categories': [{'measurements': [{'value': '12.5', 'spread': '2.14', 'groupId': 'BG000'}, {'value': '12.5', 'spread': '2.13', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '2.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7048', 'groupId': 'BG000'}, {'value': '3532', 'groupId': 'BG001'}, {'value': '10580', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6872', 'groupId': 'BG000'}, {'value': '3417', 'groupId': 'BG001'}, {'value': '10289', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '6497', 'groupId': 'BG000'}, {'value': '3246', 'groupId': 'BG001'}, {'value': '9743', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '2370', 'groupId': 'BG000'}, {'value': '1178', 'groupId': 'BG001'}, {'value': '3548', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '2312', 'groupId': 'BG000'}, {'value': '1152', 'groupId': 'BG001'}, {'value': '3464', 'groupId': 'BG002'}]}]}, {'title': 'Honduras', 'categories': [{'measurements': [{'value': '1866', 'groupId': 'BG000'}, {'value': '933', 'groupId': 'BG001'}, {'value': '2799', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '875', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '1315', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20869}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2016-01-11', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2011-06-14', 'dispFirstSubmitQcDate': '2016-01-11', 'resultsFirstSubmitDate': '2016-09-25', 'studyFirstSubmitQcDate': '2011-06-15', 'dispFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-05', 'studyFirstPostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': '28 days and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction (RT-PCR) and/or dengue non-structural (NS) protein 1 antigen enzyme-linked immunosorbent assay (ELISA). Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.'}], 'secondaryOutcomes': [{'measure': 'Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Day 0 up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.'}, {'measure': 'Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': '28 days post-injection 1 and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.'}, {'measure': 'Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': '28 days post-injection 2 and up to 13 months post-injection 3', 'description': 'Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \\>= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.'}, {'measure': 'Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Day 0 to the end of study (up to 72 months)', 'description': 'Dengue hemorrhagic fever (DHF) cases were defined as number of participants with at least one symptomatic VCD episode meeting the 1997 WHO criteria. (a) Fever: acute onset, high (\\>= 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet \\<=100 x 109/L) and plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion (seen on CXR) and/or ascites and/ or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish a clinical diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhage.'}, {'measure': 'Number of Symptomatic VCD Cases Meeting WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)', 'description': 'The 1997 WHO criteria are: a) Fever: acute onset, high (\\>= 38°C) and continuous, for 2 to 7 days and (b) any of the following: thrombocytopenia (platelet \\<=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participant, usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse.'}, {'measure': 'Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Day 0 up to the end of study (up to 72 months)', 'description': 'Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) requiring hospitalization.'}, {'measure': 'Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to end of the study (up to 72 months)', 'description': 'Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature \\>=38°C on at least 2 consecutive days) requiring hospitalization.'}, {'measure': 'Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Day 0 to the end of study (up to 72 months)', 'description': 'The severity of VCD cases was assessed by an Independent Data monitoring Committee (IDMC) based on a medical review of cases and any of the following criteria:1) Platelet count \\<=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure \\<= 20 mmHg in a child, or hypotension \\[\\<= 90 mmHg\\] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by Glasgow Coma Scale (GCS) score 5) Liver impairment (AST \\>1000 IU/L or prothrombin time \\[PT\\] International normalized ratio \\[INR\\] \\>1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine \\>= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.'}, {'measure': 'Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)', 'description': 'The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:-1) Platelet count \\<=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure \\<= 20 mmHg in a child, or hypotension \\[\\<= 90 mmHg\\] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST \\>1000 IU/L or PT INR \\>1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine \\>= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.'}, {'measure': 'Percentage of Participants With Antibody Titers >=10 1/Dil Against Each Dengue Virus Serotype Before and Following Injection (Inj.) With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit [V] 07) and 60 months (Visit [V] 12) post-injection 3', 'description': 'Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (parental strains) were measured by the plaque reduction neutralization test in a pre-defined subset of participants.'}, {'measure': 'Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo', 'timeFrame': 'Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3', 'description': 'Geometric mean titers for each of the 4 dengue virus serotypes (parental strains) were assessed using the plaque reduction neutralization test in a pre-defined subset of participants.'}, {'measure': 'Number of Participants With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Within 7 days after each and any injection', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (9-11 years): Pain: incapacitating, unable to perform usual activities; Erythema and Swelling, \\>= 50 mm. Grade 3 Solicited injection site reactions (12-16 years): Pain: significant, prevents daily activity; Erythema and Swelling, \\>100 mm.'}, {'measure': 'Number of Participants With Solicited Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Within 14 days after each and any injection', 'description': 'Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: \\>= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dengue Virus', 'Dengue fever', 'Dengue Hemorrhagic Fever', 'CYD dengue vaccine', 'Flavivirus', 'Dengue Disease'], 'conditions': ['Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue']}, 'referencesModule': {'references': [{'pmid': '25365753', 'type': 'RESULT', 'citation': 'Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C, Reynales H, Costa MS, Morales-Ramirez JO, Carrasquilla G, Rey LC, Dietze R, Luz K, Rivas E, Miranda Montoya MC, Cortes Supelano M, Zambrano B, Langevin E, Boaz M, Tornieporth N, Saville M, Noriega F; CYD15 Study Group. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015 Jan 8;372(2):113-23. doi: 10.1056/NEJMoa1411037. Epub 2014 Nov 3.'}, {'pmid': '26214039', 'type': 'RESULT', 'citation': 'Hadinegoro SR, Arredondo-Garcia JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, Muhammad Ismail HI, Reynales H, Limkittikul K, Rivera-Medina DM, Tran HN, Bouckenooghe A, Chansinghakul D, Cortes M, Fanouillere K, Forrat R, Frago C, Gailhardou S, Jackson N, Noriega F, Plennevaux E, Wartel TA, Zambrano B, Saville M; CYD-TDV Dengue Vaccine Working Group. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease. N Engl J Med. 2015 Sep 24;373(13):1195-206. doi: 10.1056/NEJMoa1506223. Epub 2015 Jul 27.'}, {'pmid': '29408333', 'type': 'RESULT', 'citation': 'Arredondo-Garcia JL, Hadinegoro SR, Reynales H, Chua MN, Rivera Medina DM, Chotpitayasunondh T, Tran NH, Deseda CC, Wirawan DN, Cortes Supelano M, Frago C, Langevin E, Coronel D, Laot T, Perroud AP, Sanchez L, Bonaparte M, Limkittikul K, Chansinghakul D, Gailhardou S, Noriega F, Wartel TA, Bouckenooghe A, Zambrano B; CYD-TDV Dengue Vaccine Study Group. Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America. Clin Microbiol Infect. 2018 Jul;24(7):755-763. doi: 10.1016/j.cmi.2018.01.018. Epub 2018 Feb 8.'}, {'pmid': '27007959', 'type': 'RESULT', 'citation': "L'Azou M, Moureau A, Sarti E, Nealon J, Zambrano B, Wartel TA, Villar L, Capeding MR, Ochiai RL; CYD14 Primary Study Group; CYD15 Primary Study Group. Symptomatic Dengue in Children in 10 Asian and Latin American Countries. 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Analysis of Hospitalized and Severe Dengue Cases Over the 6 years of Follow-up of the Tetravalent Dengue Vaccine (CYD-TDV) Efficacy Trials in Asia and Latin America. Clin Infect Dis. 2021 Sep 15;73(6):1003-1012. doi: 10.1093/cid/ciab288.'}, {'pmid': '33212068', 'type': 'DERIVED', 'citation': 'DiazGranados CA, Bonaparte M, Wang H, Zhu M, Lustig Y, Schwartz E, Forrat R, Dayan GH, Hodge S, Ataman-Onal Y, Savarino SJ. Accuracy and efficacy of pre-dengue vaccination screening for previous dengue infection with five commercially available immunoassays: a retrospective analysis of phase 3 efficacy trials. Lancet Infect Dis. 2021 Apr;21(4):529-536. doi: 10.1016/S1473-3099(20)30695-2. Epub 2020 Nov 16.'}, {'pmid': '32040014', 'type': 'DERIVED', 'citation': 'Reynales H, Carrasquilla G, Zambrano B, Cortes S M, Machabert T, Jing J, Pallardy S, Haney O, Faccini M, Quintero J, Noriega F. 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Elife. 2017 Sep 5;6:e24196. doi: 10.7554/eLife.24196.'}, {'pmid': '27459266', 'type': 'DERIVED', 'citation': 'Harenberg A, de Montfort A, Jantet-Blaudez F, Bonaparte M, Boudet F, Saville M, Jackson N, Guy B. Cytokine Profile of Children Hospitalized with Virologically-Confirmed Dengue during Two Phase III Vaccine Efficacy Trials. PLoS Negl Trop Dis. 2016 Jul 26;10(7):e0004830. doi: 10.1371/journal.pntd.0004830. eCollection 2016 Jul.'}, {'pmid': '27418050', 'type': 'DERIVED', 'citation': 'Olivera-Botello G, Coudeville L, Fanouillere K, Guy B, Chambonneau L, Noriega F, Jackson N; CYD-TDV Vaccine Trial Group. Tetravalent Dengue Vaccine Reduces Symptomatic and Asymptomatic Dengue Virus Infections in Healthy Children and Adolescents Aged 2-16 Years in Asia and Latin America. J Infect Dis. 2016 Oct 1;214(7):994-1000. doi: 10.1093/infdis/jiw297. Epub 2016 Jul 14.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The aim of the study was to assess the efficacy of Sanofi Pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.\n\nPrimary Objective:\n\nTo assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion.\n\nSecondary Objectives:\n\n* To describe the efficacy of CYD dengue vaccine in preventing symptomatic VCD cases after the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses.\n* To describe the occurrence of hospitalized VCD cases and the occurrence of severe (clinically severe or as per World Health Organization (WHO) criteria) VCD cases, throughout the Surveillance Expansion Period (SEP) and throughout the trial (from Day 0 until the end of the study).\n* To describe the antibody response to each dengue serotype after Dose 2, after Dose 3, and 1 and 5 years after Dose 3.\n* To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all participants throughout the trial period.", 'detailedDescription': 'Participants were randomized to either receive 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months.\n\nA subset of participants from each country (N=2000) was also evaluated for reactogenicity and immunogenicity.\n\nFor each participant, the Active Phase of dengue case detection began after the first injection (Dose 1) and continued until 13 months after the third injection (Dose 3). It was assumed that 12 months of surveillance should result in the detection of a sufficient number of VCD cases to allow for an assessment of efficacy.\n\nThe Hospital Phase began after the Active Phase. Participants with a febrile illness and requiring hospitalization were screened for dengue until the end of the study.\n\nParticipants who consented to participate in the SEP were actively followed for dengue case detection (i.e. at least weekly contact and capturing any acute febrile illness, not just hospitalized febrile cases, as in the Active Phase). The SEP was designed to maximize the detection of symptomatic VCD (hospitalized or not) in order to describe CYD dengue vaccine efficacy and safety in preventing symptomatic dengue in the long-term. Participants who declined participating in the SEP continued surveillance as in the Hospital Phase until trial completion.\n\nSymptomatic VCD cases occurring more than (\\>) 28 days after dose 3 (during the Active Phase) are defined as:\n\n* Acute febrile illness (i.e. temperature \\>=38 degree Celsius (°C) on at least 2 consecutive days)\n* Virologically confirmed by dengue Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) and/or dengue non-structural (NS)1 enzyme-linked immunosorbent assay (ELISA) Ag test.\n\nSeverity was assessed using a definition consistent with the 1997 WHO Classification Dengue Hemorrhagic Fever and by an independent Data Monitoring Committee (IDMC) severity criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 9 to 16 years on the day of inclusion and resident of the site zone\n* Participant in good health, based on medical history and physical examination\n* Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)\n* Participant was able to attend all scheduled visits and comply with all trial procedures.\n\nExclusion Criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination).\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Self-reported or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\n* Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection\n* Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion\n* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response\n* Planned receipt of any vaccine in the 4 weeks following any trial vaccination\n* Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures\n* Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator."}, 'identificationModule': {'nctId': 'NCT01374516', 'briefTitle': 'Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America', 'orgStudyIdInfo': {'id': 'CYD15'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1116-4986', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYD Dengue Vaccine Group', 'description': 'Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.', 'interventionNames': ['Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants were to receive a placebo vaccine at 0, 6, and 12 months.', 'interventionNames': ['Biological: Placebo: (NaCl) 0.9% solution']}], 'interventions': [{'name': 'Live, attenuated, dengue serotype 1, 2, 3, 4 virus', 'type': 'BIOLOGICAL', 'otherNames': ['CYD Dengue Vaccine'], 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['CYD Dengue Vaccine Group']}, {'name': 'Placebo: (NaCl) 0.9% solution', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60430 270', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '29040 09', 'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'zip': '74675 020', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '79074 460', 'city': 'Campo Grande', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'geoPoint': {'lat': -20.44278, 'lon': -54.64639}}, {'zip': '59025 600', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'city': 'Aguazul', 'state': 'Casanare Department', 'country': 'Colombia', 'geoPoint': {'lat': 5.17282, 'lon': -72.54706}}, {'city': 'Yopal', 'state': 'Casanare Department', 'country': 'Colombia', 'geoPoint': {'lat': 5.33573, 'lon': -72.3939}}, {'city': 'Girardot City', 'state': 'Cundinamarca', 'country': 'Colombia', 'geoPoint': {'lat': 4.30079, 'lon': -74.80754}}, {'city': 'Acacías', 'state': 'Meta Department', 'country': 'Colombia', 'geoPoint': {'lat': 3.98695, 'lon': -73.75797}}, {'city': 'Armenia', 'state': 'Quindío Department', 'country': 'Colombia', 'geoPoint': {'lat': 4.53656, 'lon': -75.67263}}, {'city': 'Calarcá', 'state': 'Quindío Department', 'country': 'Colombia', 'geoPoint': {'lat': 4.52949, 'lon': -75.64091}}, {'city': 'La Tebaida', 'state': 'Quindío Department', 'country': 'Colombia', 'geoPoint': {'lat': 4.45265, 'lon': -75.78746}}, {'city': 'Montenegro', 'state': 'Quindío Department', 'country': 'Colombia', 'geoPoint': {'lat': 4.56639, 'lon': -75.75111}}, {'city': 'Bucaramanga', 'state': 'Santander Department', 'country': 'Colombia', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Tegucigalpa', 'state': 'Municipalidad Del Distrito Central', 'country': 'Honduras', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}, {'city': 'Temixco', 'state': 'Morelos', 'country': 'Mexico', 'geoPoint': {'lat': 18.85254, 'lon': -99.22537}}, {'city': 'Municipio de Cd. Mante', 'state': 'Tamaulipas', 'country': 'Mexico'}, {'city': 'Veracruz Puerto', 'state': 'Veracruz', 'country': 'Mexico'}, {'city': 'Tizimín', 'state': 'Yucatán', 'country': 'Mexico', 'geoPoint': {'lat': 21.14304, 'lon': -88.15188}}, {'city': 'Valladolid', 'state': 'Yucatán', 'country': 'Mexico', 'geoPoint': {'lat': 20.68812, 'lon': -88.19936}}, {'zip': '00784', 'city': 'Guayama', 'country': 'Puerto Rico', 'geoPoint': {'lat': 17.98413, 'lon': -66.11378}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}