Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00788151
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2008-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
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': 'C445780', 'term': 'ChimeriVax'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}], 'ancestors': [{'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Director', 'organization': 'Sanofi Pasteur SA'}, '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 participant 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 event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.', 'description': 'Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 71, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 29, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Injection site Pain; Post-injection 1, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Erythema; Post-injection 1, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Swelling; Post-injection 1, all participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Pain; Post-injection 2, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Pain; Post-injection 3, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Erythema; Post-injection 3, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site Swelling; Post-injection 3, All participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 186, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epiphyseal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Inj. site Pain; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '32.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 1 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 2 (All ages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 2 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 3 (2-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Inj. site Pain: Post-Inj.1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 1 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 2 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 3 (2-5 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Inj. site Pain; Post-Inj.1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Pain; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Erythema; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Inj. site Swelling; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 1 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 2 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Fever; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Headache; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '36.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Malaise; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Asthenia; Post-Inj. 3 (6-11 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '46.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '23.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '32.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '32.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '39.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '44.7', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '47.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \\>= 10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '65.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Dengue parental serotype 1; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 1; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 2; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 3; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '22.4', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '36.2', 'groupId': 'OG001'}]}]}, {'title': 'Dengue parental serotype 4; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'At least 1 positive serotype; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '42.4', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '38.4', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '22.6', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '25.8', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; Pre-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; Pre-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. 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Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'At least 1 positive serotype; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '44.2', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '16.0', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}, {'value': '37.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>= 10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'At least 1 positive serotype; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '51.1', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 positive serotype; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '71.7', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 2 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '40.8', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 3 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; Pre-Inj. 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '22.4', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}, {'title': 'All 4 positive serotypes; 28 days Post-Inj. 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '41.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and \'number analyzed\' = participants with available data for specified category.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Serotype 1; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '23.2'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '34.8'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '159'}, {'value': '26.4', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '41.8'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '224'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '62.1'}]}]}, {'title': 'Serotype 2; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '18.3'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '25.8'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000', 'lowerLimit': '128', 'upperLimit': '178'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '23.9'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000', 'lowerLimit': '152', 'upperLimit': '207'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '31.5'}]}]}, {'title': 'Serotype 3; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '21.2'}, {'value': '21.8', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '31.3'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '186'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '39.0'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '224'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '52.0'}]}]}, {'title': 'Serotype 4; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.12', 'groupId': 'OG000', 'lowerLimit': '6.91', 'upperLimit': '9.54'}, {'value': '8.94', 'groupId': 'OG001', 'lowerLimit': '6.97', 'upperLimit': '11.5'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '166'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '9.50', 'upperLimit': '17.2'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000', 'lowerLimit': '159', 'upperLimit': '212'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '22.8'}]}]}, {'title': 'Serotype 1; 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Pre-Inj. 1, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '8.94', 'upperLimit': '15.6'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '9.31', 'upperLimit': '20.6'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 2, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '168'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '8.80', 'upperLimit': '19.9'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 3, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000', 'lowerLimit': '163', 'upperLimit': '234'}, {'value': '21.8', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '39.2'}]}]}, {'title': 'Serotype 3; Pre-Inj. 1, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '23.4'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '27.4'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 2, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '131', 'upperLimit': '224'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '45.7'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 3, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '169', 'upperLimit': '270'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '60.6'}]}]}, {'title': 'Serotype 4; Pre-Inj. 1, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '6.20', 'upperLimit': '9.70'}, {'value': '9.02', 'groupId': 'OG001', 'lowerLimit': '6.27', 'upperLimit': '13.0'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 2, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '203'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '8.83', 'upperLimit': '23.6'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 3, 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '181', 'upperLimit': '276'}, {'value': '18.7', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '31.4'}]}]}, {'title': 'Serotype 1; Pre-Inj. 1, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '28.4'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '63.1'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 2, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '165'}, {'value': '36.2', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '71.0'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000', 'lowerLimit': '115', 'upperLimit': '216'}, {'value': '45.8', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '88.8'}]}]}, {'title': 'Serotype 2; Pre-Inj. 1, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '26.3'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '43.1'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 2, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '130', 'upperLimit': '216'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '37.0'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000', 'lowerLimit': '127', 'upperLimit': '208'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '35.6'}]}]}, {'title': 'Serotype 3; Pre-Inj. 1, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '24.0'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '48.7'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 2, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '182'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '46.8'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '213'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '61.6'}]}]}, {'title': 'Serotype 4; Pre-Inj. 1, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.50', 'groupId': 'OG000', 'lowerLimit': '6.72', 'upperLimit': '10.8'}, {'value': '8.87', 'groupId': 'OG001', 'lowerLimit': '6.21', 'upperLimit': '12.6'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 2, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '153'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '7.96', 'upperLimit': '16.3'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '184'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '22.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.', 'unitOfMeasure': 'Titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Pre-Inj. 1; All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}, {'title': '28 days Post-Inj. 1; All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '83.2', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Inj. 1; 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}]}]}, {'title': '28 days Post-Inj. 1; 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}, {'value': '72.9', 'groupId': 'OG001'}]}]}, {'title': 'Pre-Inj. 1; 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}, {'title': '28 days Post-Inj. 1; 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '93.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 1', 'description': 'Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Pre-Inj. 1; All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '39.4'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '47.7'}]}]}, {'title': '28 days Post-Inj. 1; All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '52.8'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '47.3'}]}]}, {'title': 'Pre-Inj. 1; 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '20.6'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '30.7'}]}]}, {'title': '28 days Post-Inj. 1; 2-5 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '28.7'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '31.1'}]}]}, {'title': 'Pre-Inj. 1; 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '82.9'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '45.8', 'upperLimit': '89.2'}]}]}, {'title': '28 days Post-Inj. 1; 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000', 'lowerLimit': '66.2', 'upperLimit': '104'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '44.0', 'upperLimit': '86.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 1', 'description': 'GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.', 'unitOfMeasure': 'Titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}, {'type': 'SECONDARY', 'title': 'GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'classes': [{'title': 'Serotype 1; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '25.6'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '36.9'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj.1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '61.9'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '35.1'}]}]}, {'title': 'Serotype 1; Pre-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '41.7'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '41.5'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000', 'lowerLimit': '171', 'upperLimit': '266'}, {'value': '26.1', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '42.0'}]}]}, {'title': 'Serotype 1; Pre-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '89.2'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '49.3'}]}]}, {'title': 'Serotype 1; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000', 'lowerLimit': '203', 'upperLimit': '318'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '58.7'}]}]}, {'title': 'Serotype 2; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.55', 'groupId': 'OG000', 'lowerLimit': '6.50', 'upperLimit': '8.78'}, {'value': '7.76', 'groupId': 'OG001', 'lowerLimit': '6.31', 'upperLimit': '9.53'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj.1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '19.4'}, {'value': '7.51', 'groupId': 'OG001', 'lowerLimit': '6.19', 'upperLimit': '9.12'}]}]}, {'title': 'Serotype 2; Pre-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '9.52', 'upperLimit': '14.1'}, {'value': '7.32', 'groupId': 'OG001', 'lowerLimit': '6.06', 'upperLimit': '8.84'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '25.9'}, {'value': '6.99', 'groupId': 'OG001', 'lowerLimit': '5.82', 'upperLimit': '8.39'}]}]}, {'title': 'Serotype 2; Pre-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '9.39', 'upperLimit': '13.8'}, {'value': '7.26', 'groupId': 'OG001', 'lowerLimit': '6.01', 'upperLimit': '8.78'}]}]}, {'title': 'Serotype 2; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '26.4'}, {'value': '7.73', 'groupId': 'OG001', 'lowerLimit': '6.24', 'upperLimit': '9.58'}]}]}, {'title': 'Serotype 3; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '16.5'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '22.8'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj.1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '55.4'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '21.3'}]}]}, {'title': 'Serotype 3; Pre-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '29.5'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '21.2'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '150'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '21.5'}]}]}, {'title': 'Serotype 3; Pre-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '24.3', 'upperLimit': '39.6'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '19.0'}]}]}, {'title': 'Serotype 3; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '84.8', 'upperLimit': '116'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '22.2'}]}]}, {'title': 'Serotype 4; Pre-Inj. 1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.52', 'groupId': 'OG000', 'lowerLimit': '6.37', 'upperLimit': '8.87'}, {'value': '8.08', 'groupId': 'OG001', 'lowerLimit': '6.39', 'upperLimit': '10.2'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj.1, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '65.4', 'upperLimit': '118'}, {'value': '7.84', 'groupId': 'OG001', 'lowerLimit': '6.25', 'upperLimit': '9.83'}]}]}, {'title': 'Serotype 4; Pre-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '26.8'}, {'value': '7.73', 'groupId': 'OG001', 'lowerLimit': '6.27', 'upperLimit': '9.53'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 2, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '186'}, {'value': '7.81', 'groupId': 'OG001', 'lowerLimit': '6.27', 'upperLimit': '9.74'}]}]}, {'title': 'Serotype 4; Pre-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '31.7', 'upperLimit': '48.5'}, {'value': '7.49', 'groupId': 'OG001', 'lowerLimit': '6.06', 'upperLimit': '9.26'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 3, All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '172'}, {'value': '8.54', 'groupId': 'OG001', 'lowerLimit': '6.71', 'upperLimit': '10.9'}]}]}, {'title': 'Serotype 1; 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28 days Post-Inj. 2, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '164'}, {'value': '7.44', 'groupId': 'OG001', 'lowerLimit': '5.63', 'upperLimit': '9.83'}]}]}, {'title': 'Serotype 4; Pre-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '53.2'}, {'value': '7.06', 'groupId': 'OG001', 'lowerLimit': '5.37', 'upperLimit': '9.29'}]}]}, {'title': 'Serotype 4; 28 days Post-Inj. 3, 6-11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '157'}, {'value': '7.82', 'groupId': 'OG001', 'lowerLimit': '5.79', 'upperLimit': '10.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.', 'unitOfMeasure': 'Titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'Received Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'Received Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Received Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Other adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.', 'preAssignmentDetails': 'A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CYD Dengue Vaccine Group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '2 to 5 years', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': '6 to 11 years', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed in Full analysis set which included all the participants present at vaccination 1 and received at least 1 dose of vaccine.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2010-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2008-11-07', 'resultsFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2008-11-07', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-24', 'studyFirstPostDateStruct': {'date': '2008-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.'}, {'measure': 'Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.'}, {'measure': 'Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3', 'description': 'Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \\>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \\> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \\>= 10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>= 10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>= 10 1/dilution.'}, {'measure': 'Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution.'}, {'measure': 'Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 2 and 3', 'description': 'GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.'}, {'measure': 'Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 1', 'description': 'Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \\>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.'}, {'measure': 'GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1 and 28 days Post-Injection 1', 'description': 'GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.'}, {'measure': 'GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo', 'timeFrame': 'Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3', 'description': 'GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dengue virus', 'Dengue fever', 'Dengue Hemorrhagic fever', 'Dengue diseases', 'Dengue vaccine'], 'conditions': ['Dengue Virus', 'Dengue Fever', 'Dengue Hemorrhagic Fever', 'Dengue Diseases']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.'}, {'pmid': '22863660', 'type': 'RESULT', 'citation': 'Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, Saville M, Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012 Sep 7;30(41):5935-41. doi: 10.1016/j.vaccine.2012.07.043. Epub 2012 Jul 31.'}], 'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.\n\nPrimary Objectives:\n\n* To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.\n* To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).\n* To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).', 'detailedDescription': 'Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Aged 2 to 11 years on the day of inclusion.\n* Participant in good health, based on medical history, physical examination and laboratory parameters.\n* Provision of Assent Form signed by the participants (for participants \\>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\\[s\\]).\n* Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.\n* For a female participant of child-bearing potential (girls post-menarche), 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* Documented receipt of yellow fever vaccine since at least one month before the first 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 (girls post-menarche), known pregnancy.\n* For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.\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 trial.\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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.\n* Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.\n* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.\n* Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.\n* Receipt of any blood or blood-derived products in the past 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* Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.\n* Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.\n* Known previous vaccination with pneumococcal polysaccharide vaccine."}, 'identificationModule': {'nctId': 'NCT00788151', 'briefTitle': 'Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru', 'orgStudyIdInfo': {'id': 'CYD24'}, 'secondaryIdInfos': [{'id': '2014-001711-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CYD Dengue vaccine group', 'description': 'Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).', 'interventionNames': ['Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).', 'interventionNames': ['Biological: Pneumococcal polysaccharide vaccine']}], 'interventions': [{'name': 'CYD Dengue Vaccine Serotypes 1, 2, 3, and 4', 'type': 'BIOLOGICAL', 'otherNames': ['ChimeriVax™'], 'description': '0.5 mL, Subcutaneous (SC)', 'armGroupLabels': ['CYD Dengue vaccine group']}, {'name': 'Pneumococcal polysaccharide vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumo23®'], 'description': '0.5 mL, SC', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chulucanas Morropon', 'state': 'Piura', 'country': 'Peru'}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur SA'}]}, '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'}}}}