Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 9:32 AM
Study NCT ID:
NCT01187433
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2010-08-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South 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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'C509326', 'term': 'adacel'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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': 'Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3', 'eventGroups': [{'id': 'EG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.', 'otherNumAtRisk': 100, 'otherNumAffected': 61, 'seriousNumAtRisk': 100, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.', 'otherNumAtRisk': 50, 'otherNumAffected': 25, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache: Post Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 61, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site Pain; Post Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site Swelling; Post Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fever; Post Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malaise; Post-Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia; Post-Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia; Post-Any Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intra uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Serotype 1; Pre-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '79.8', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Pre-Injection 3 (n=90, 46)', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 3 (n=90, 46)', 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000'}, {'value': '76.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '76.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}, {'value': '67.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '71.7', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '73.9', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Pre-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Post -njection 1 (n=99, 48)', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '57.4', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Post-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Pre-Injection 3 (n=88, 46)', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '73.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seropositivity was assessed in the Full Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Serotype 1; Pre-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000'}, {'value': '82.9', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Pre-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Pre-Injection 3 (n=74, 38)', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '81.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 1; Post-Injection 3 (n=73, 38)', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '81.6', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '89.7', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Pre-Injection 3 (n=74, 38)', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2; Post-Injection 3 (n=73, 38)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 1 (n=80, 41)', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '87.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Pre-Injection 3 (n=74, 38)', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3; Post-Injection 3 (n=73, 38)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4; 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Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '1.91'}, {'value': '0.673', 'groupId': 'OG001', 'lowerLimit': '0.489', 'upperLimit': '0.925'}]}]}, {'title': 'Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46)', 'categories': [{'measurements': [{'value': '1.53', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '1.86'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.681', 'upperLimit': '0.94'}]}]}, {'title': 'Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '26.0'}, {'value': '0.806', 'groupId': 'OG001', 'lowerLimit': '0.665', 'upperLimit': '0.976'}]}]}, {'title': 'Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '19.2'}, {'value': '1.27', 'groupId': 'OG001', 'lowerLimit': '0.795', 'upperLimit': '2.04'}]}]}, {'title': 'Serotype 4; 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Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000', 'lowerLimit': '173', 'upperLimit': '475'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '238'}]}]}, {'title': 'Serotype 2; Post-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '647', 'groupId': 'OG000', 'lowerLimit': '449', 'upperLimit': '932'}, {'value': '137', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '306'}]}]}, {'title': 'Serotype 2; Pre-Injection 3 (n=90, 46)', 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000', 'lowerLimit': '219', 'upperLimit': '592'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '65.7', 'upperLimit': '262'}]}]}, {'title': 'Serotype 2; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '544', 'groupId': 'OG000', 'lowerLimit': '378', 'upperLimit': '782'}, {'value': '132', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '259'}]}]}, {'title': 'Serotype 3; 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Pre-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '481', 'groupId': 'OG000', 'lowerLimit': '300', 'upperLimit': '772'}, {'value': '144', 'groupId': 'OG001', 'lowerLimit': '65.8', 'upperLimit': '316'}]}]}, {'title': 'Serotype 3; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '741', 'groupId': 'OG000', 'lowerLimit': '516', 'upperLimit': '1062'}, {'value': '140', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '298'}]}]}, {'title': 'Serotype 4; Pre-Injection 1 (n=99, 49)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '19.4'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '25.8'}]}]}, {'title': 'Serotype 4; Post-Injection 1 (n=99, 48)', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000', 'lowerLimit': '262', 'upperLimit': '559'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '27.7'}]}]}, {'title': 'Serotype 4; Pre-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '238'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '45.8'}]}]}, {'title': 'Serotype 4; Post-Injection 2 (n=94, 47)', 'categories': [{'measurements': [{'value': '346', 'groupId': 'OG000', 'lowerLimit': '281', 'upperLimit': '425'}, {'value': '31.2', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '53.7'}]}]}, {'title': 'Serotype 4; Pre-Injection 3 (n=88, 46)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000', 'lowerLimit': '192', 'upperLimit': '347'}, {'value': '37.4', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '62.1'}]}]}, {'title': 'Serotype 4; Post-Injection 3 (n=89, 46)', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000', 'lowerLimit': '335', 'upperLimit': '556'}, {'value': '33.4', 'groupId': 'OG001', 'lowerLimit': '21.5', 'upperLimit': '51.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).', 'unitOfMeasure': 'Titers (1/dilutions)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the Full Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.'}], 'classes': [{'title': 'Serotype 1; 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Pre-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '591', 'groupId': 'OG000', 'lowerLimit': '376', 'upperLimit': '928'}, {'value': '224', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '446'}]}]}, {'title': 'Serotype 2; Post-Injection 2 (n=78, 39)', 'categories': [{'measurements': [{'value': '978', 'groupId': 'OG000', 'lowerLimit': '697', 'upperLimit': '1374'}, {'value': '271', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '610'}]}]}, {'title': 'Serotype 2; Pre-Injection 3 (n=74, 38)', 'categories': [{'measurements': [{'value': '648', 'groupId': 'OG000', 'lowerLimit': '400', 'upperLimit': '1048'}, {'value': '240', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '471'}]}]}, {'title': 'Serotype 2; Post-Injection 3 (n=73, 38)', 'categories': [{'measurements': [{'value': '835', 'groupId': 'OG000', 'lowerLimit': '584', 'upperLimit': '1193'}, {'value': '242', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '463'}]}]}, {'title': 'Serotype 3; 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Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Injection 2 (N=94, 47)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Injection 3 (N=82, 43)', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Injection 3 (N=82, 43)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Injection 3 (N=89, 45)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 14 post each vaccination', 'description': 'Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \\>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.', 'preAssignmentDetails': 'A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '150', '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': '12.7', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '12.7', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '12.7', 'spread': '2.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2013-11-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2010-08-20', 'dispFirstSubmitQcDate': '2013-11-04', 'resultsFirstSubmitDate': '2016-09-25', 'studyFirstSubmitQcDate': '2010-08-20', 'dispFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-25', 'studyFirstPostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).'}, {'measure': 'Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.'}, {'measure': 'Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 Days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \\<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.'}, {'measure': 'Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).'}, {'measure': 'Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.'}, {'measure': 'Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \\<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.'}, {'measure': 'Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).'}, {'measure': 'Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).'}, {'measure': 'Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.'}, {'measure': 'Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Before and 28 days after each injection', 'description': 'Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \\<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.'}, {'measure': 'Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo', 'timeFrame': 'Day 0 up to Day 14 post each vaccination', 'description': 'Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \\>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dengue', 'Dengue hemorrhagic fever', 'CYD Dengue Vaccines'], 'conditions': ['Dengue', 'Dengue Hemorrhagic Fever']}, 'referencesModule': {'references': [{'pmid': '24189367', 'type': 'RESULT', 'citation': 'Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-1065. doi: 10.4269/ajtmh.13-0304. Epub 2013 Nov 4.'}, {'pmid': '32932330', 'type': 'DERIVED', 'citation': 'Coronel D, Garcia-Rivera EJ, Rivera DM, Arredondo-Garcia JL, Dietze R, Perroud AP, Cortes M, Bonaparte M, Wang H, Pagnon A, Jantet-Blaudez F, Penalosa LAR, Dayan G, Zambrano B, DiazGranados CA, Noriega F. Immune Response Persistence and Safety of a Booster Dose of the Tetravalent Dengue Vaccine in Adolescents and Adults Who Previously Completed the 3-dose Schedule 4-5 Years Earlier in Latin America: A Randomized Placebo-controlled Trial. Pediatr Infect Dis J. 2020 Oct;39(10):961-968. doi: 10.1097/INF.0000000000002830.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.\n\nPrimary Objectives:\n\n* To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.\n* To evaluate the safety of each vaccination with CYD dengue vaccine.', 'detailedDescription': 'Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.'}, '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\n* Participant in good health, based on medical history and physical examination\n* Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative\n* Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures\n* For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination\n\nExclusion Criteria :\n\n* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia\n* For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1\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* Breast-feeding woman\n* Planned participation in another clinical trial during the present trial period\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy\n* Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator\n* Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures\n* Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination\n* Planned receipt of any vaccine in the 4 weeks following the first trial vaccination\n* Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent\n* Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment\n* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination\n* Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression."}, 'identificationModule': {'nctId': 'NCT01187433', 'briefTitle': 'Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America', 'orgStudyIdInfo': {'id': 'CYD30'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1111-6073', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dengue Vaccine Group', 'description': 'Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine', 'interventionNames': ['Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants will receive a placebo, NaCl 0.9%.', 'interventionNames': ['Biological: NaCl 0.9%', 'Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed', 'Biological: Meningococcal A+C vaccine']}], 'interventions': [{'name': 'Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus', 'type': 'BIOLOGICAL', 'otherNames': ['CYD Dengue Vaccine'], 'description': '0.5 mL, Subcutaneous (SC)', 'armGroupLabels': ['Dengue Vaccine Group']}, {'name': 'NaCl 0.9%', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Subcutaneous', 'armGroupLabels': ['Control Group']}, {'name': 'Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed', 'type': 'BIOLOGICAL', 'otherNames': ['ADACEL®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Control Group']}, {'name': 'Meningococcal A+C vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ES, 29040-091', 'city': 'Vitória', 'country': 'Brazil', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}], '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'}}}}