Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 12:55 PM
Study NCT ID:
NCT01542632
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 0 to Day 120', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).", 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.', 'otherNumAtRisk': 25, 'otherNumAffected': 18, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.', 'otherNumAtRisk': 24, 'otherNumAffected': 20, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.', 'otherNumAtRisk': 21, 'otherNumAffected': 16, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.', 'otherNumAtRisk': 21, 'otherNumAffected': 17, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.', 'otherNumAtRisk': 24, 'otherNumAffected': 18, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90)."}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.'}], 'classes': [{'title': 'Edema=0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'Erythema=0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}]}, {'title': 'Itching=0', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Itching=1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Pain=0', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'Pain=1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Pain=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 104', 'description': 'Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': 'Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).'}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'classes': [{'title': 'Day 7 Dengue-2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'Day 9 Dengue-2', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}]}, {'title': 'Day 9 Dengue-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 11 Dengue-2', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}]}]}, {'title': 'Day 11 Dengue-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 11 Dengue-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 14 Dengue-2', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}]}, {'title': 'Day 17 Dengue-1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 17 Dengue-2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Day 21 Dengue-2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 90 Dengue-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'various timepoints up to 30 days after each dose (Up to Day 120)', 'description': 'Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': 'Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).'}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For 30 days after each dose (Up to Day 120)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': 'Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).'}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For 30 days after each dose (Up to Day 120)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': 'Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).'}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDV,P D90:TDV,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'classes': [{'title': 'Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '428.6', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '473.6', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '370.1', 'spread': '3.87', 'groupId': 'OG002'}, {'value': '45.6', 'spread': '3.97', 'groupId': 'OG003'}, {'value': '69.1', 'spread': '5.51', 'groupId': 'OG004'}, {'value': '391.4', 'spread': '3.30', 'groupId': 'OG005'}]}]}, {'title': 'Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '6411.9', 'spread': '7.83', 'groupId': 'OG000'}, {'value': '4843.3', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '6274.1', 'spread': '3.57', 'groupId': 'OG002'}, {'value': '4953.8', 'spread': '3.01', 'groupId': 'OG003'}, {'value': '5419.6', 'spread': '3.06', 'groupId': 'OG004'}, {'value': '7315.3', 'spread': '5.90', 'groupId': 'OG005'}]}]}, {'title': 'Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '62.3', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '151.0', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '70.3', 'spread': '6.10', 'groupId': 'OG002'}, {'value': '47.2', 'spread': '5.69', 'groupId': 'OG003'}, {'value': '62.0', 'spread': '6.19', 'groupId': 'OG004'}, {'value': '37.4', 'spread': '6.13', 'groupId': 'OG005'}]}]}, {'title': 'Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '8.2', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '4.65', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '5.00', 'groupId': 'OG002'}, {'value': '45.6', 'spread': '5.13', 'groupId': 'OG003'}, {'value': '21.5', 'spread': '5.89', 'groupId': 'OG004'}, {'value': '17.4', 'spread': '10.28', 'groupId': 'OG005'}]}]}, {'title': 'Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23)', 'categories': [{'measurements': [{'value': '155.6', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '130.7', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '142.2', 'spread': '6.16', 'groupId': 'OG002'}, {'value': '27.3', 'spread': '3.11', 'groupId': 'OG003'}, {'value': '37.0', 'spread': '5.91', 'groupId': 'OG004'}, {'value': '127.6', 'spread': '5.92', 'groupId': 'OG005'}]}]}, {'title': 'Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23)', 'categories': [{'measurements': [{'value': '1597.9', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '1758.7', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '1814.4', 'spread': '3.13', 'groupId': 'OG002'}, {'value': '1383.1', 'spread': '2.82', 'groupId': 'OG003'}, {'value': '1288.7', 'spread': '3.14', 'groupId': 'OG004'}, {'value': '1756.5', 'spread': '5.80', 'groupId': 'OG005'}]}]}, {'title': 'Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23)', 'categories': [{'measurements': [{'value': '32.0', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '5.38', 'groupId': 'OG002'}, {'value': '20.0', 'spread': '4.17', 'groupId': 'OG003'}, {'value': '27.7', 'spread': '4.68', 'groupId': 'OG004'}, {'value': '22.6', 'spread': '4.87', 'groupId': 'OG005'}]}]}, {'title': 'Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.44', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '3.62', 'groupId': 'OG002'}, {'value': '13.7', 'spread': '3.60', 'groupId': 'OG003'}, {'value': '11.2', 'spread': '3.62', 'groupId': 'OG004'}, {'value': '13.5', 'spread': '6.85', 'groupId': 'OG005'}]}]}, {'title': 'Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '223.2', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '136.5', 'spread': '3.88', 'groupId': 'OG001'}, {'value': '216.3', 'spread': '6.23', 'groupId': 'OG002'}, {'value': '38.6', 'spread': '2.70', 'groupId': 'OG003'}, {'value': '65.4', 'spread': '5.00', 'groupId': 'OG004'}, {'value': '179.6', 'spread': '4.85', 'groupId': 'OG005'}]}]}, {'title': 'Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '1597.9', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '1478.9', 'spread': '2.72', 'groupId': 'OG001'}, {'value': '1893.9', 'spread': '2.89', 'groupId': 'OG002'}, {'value': '1631.8', 'spread': '3.49', 'groupId': 'OG003'}, {'value': '1295.5', 'spread': '3.22', 'groupId': 'OG004'}, {'value': '1356.1', 'spread': '5.37', 'groupId': 'OG005'}]}]}, {'title': 'Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '51.3', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '3.70', 'groupId': 'OG001'}, {'value': '56.6', 'spread': '4.43', 'groupId': 'OG002'}, {'value': '30.5', 'spread': '3.36', 'groupId': 'OG003'}, {'value': '51.2', 'spread': '3.00', 'groupId': 'OG004'}, {'value': '25.9', 'spread': '3.87', 'groupId': 'OG005'}]}]}, {'title': 'Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '12.0', 'spread': '3.58', 'groupId': 'OG002'}, {'value': '23.2', 'spread': '3.52', 'groupId': 'OG003'}, {'value': '25.5', 'spread': '3.74', 'groupId': 'OG004'}, {'value': '12.8', 'spread': '5.81', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 30, 90 and 120 after 1st vaccination', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.'}, {'type': 'PRIMARY', 'title': 'Rate of Seroconversion to Each of Four Dengue Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': 'Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).'}, {'id': 'OG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'OG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'OG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'classes': [{'title': 'Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '81.0', 'groupId': 'OG003'}, {'value': '89.5', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '95.8', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '87.5', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}, {'value': '94.7', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24)', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '81.0', 'groupId': 'OG003'}, {'value': '57.9', 'groupId': 'OG004'}, {'value': '29.2', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24)', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}, {'value': '95.7', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '72.2', 'groupId': 'OG004'}, {'value': '87.5', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '91.7', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24)', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}, {'value': '82.6', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '62.5', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24)', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '38.9', 'groupId': 'OG004'}, {'value': '37.5', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}, {'value': '95.7', 'groupId': 'OG002'}, {'value': '84.2', 'groupId': 'OG003'}, {'value': '94.1', 'groupId': 'OG004'}, {'value': '95.8', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '95.8', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}, {'value': '91.3', 'groupId': 'OG002'}, {'value': '94.7', 'groupId': 'OG003'}, {'value': '94.1', 'groupId': 'OG004'}, {'value': '83.3', 'groupId': 'OG005'}]}]}, {'title': 'Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '52.2', 'groupId': 'OG002'}, {'value': '73.7', 'groupId': 'OG003'}, {'value': '76.5', 'groupId': 'OG004'}, {'value': '41.7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days after the last immunization (Up to Day 120)', 'description': 'Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90)."}, {'id': 'FG001', 'title': 'Group 2 (D0:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'FG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'FG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'FG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'FG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Sponsor/Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 3 investigative sites in the United States from 23 January 2012 to 10 January 2014.', 'preAssignmentDetails': 'Participants were enrolled in 1 of 6 treatment groups (GRP). GRP1: 1 dose TDV on Day 0 and 90, GRP2: 2 doses of TDV on Day 0, GRP3: 2 Doses of TDV on Day 0 and 1 dose of TDV on Day 90, GRP4: 1 Dose of TDV New Formula on Day 0 and 90, GRP5: 2 doses of TDV New Formula on Day 0 and 90 and GRP6: 1/10 dose of TDV on Day 0 and 90.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (D0:TDV,P D90:TDV)', 'description': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90)."}, {'id': 'BG001', 'title': 'Group 2 (DO:TDV,TDV D90:P)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'BG002', 'title': 'Group 3 (D0:TDV,TDV D90:TDV)', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.'}, {'id': 'BG003', 'title': 'Group 4 (D0:TDVN,P D90:TDVN,P)', 'description': 'TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'BG004', 'title': 'Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.'}, {'id': 'BG005', 'title': 'Group 6 (D0:1/10TDV D90:1/10TDV)', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '5.74', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '6.40', 'groupId': 'BG002'}, {'value': '30.0', 'spread': '6.67', 'groupId': 'BG003'}, {'value': '30.3', 'spread': '7.95', 'groupId': 'BG004'}, {'value': '32.5', 'spread': '6.04', 'groupId': 'BG005'}, {'value': '30.0', 'spread': '6.54', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '73', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Hispanic Or Latino', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '112', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '11.66', 'groupId': 'BG000'}, {'value': '75.9', 'spread': '13.22', 'groupId': 'BG001'}, {'value': '76.7', 'spread': '15.76', 'groupId': 'BG002'}, {'value': '80.8', 'spread': '14.12', 'groupId': 'BG003'}, {'value': '77.3', 'spread': '14.91', 'groupId': 'BG004'}, {'value': '81.7', 'spread': '16.02', 'groupId': 'BG005'}, {'value': '77.5', 'spread': '14.36', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '0.092', 'groupId': 'BG000'}, {'value': '1.71', 'spread': '0.084', 'groupId': 'BG001'}, {'value': '1.70', 'spread': '0.108', 'groupId': 'BG002'}, {'value': '1.76', 'spread': '0.105', 'groupId': 'BG003'}, {'value': '1.73', 'spread': '0.099', 'groupId': 'BG004'}, {'value': '1.75', 'spread': '0.104', 'groupId': 'BG005'}, {'value': '1.72', 'spread': '0.100', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.81', 'spread': '2.423', 'groupId': 'BG000'}, {'value': '25.97', 'spread': '3.314', 'groupId': 'BG001'}, {'value': '26.50', 'spread': '3.735', 'groupId': 'BG002'}, {'value': '26.09', 'spread': '3.202', 'groupId': 'BG003'}, {'value': '25.81', 'spread': '3.712', 'groupId': 'BG004'}, {'value': '26.35', 'spread': '3.517', 'groupId': 'BG005'}, {'value': '25.91', 'spread': '3.323', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2014-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2012-02-27', 'resultsFirstSubmitDate': '2014-12-31', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-31', 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported', 'timeFrame': 'Day 0 to Day 104', 'description': 'Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.'}, {'measure': 'Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose', 'timeFrame': 'For 30 days after each dose (Up to Day 120)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.'}, {'measure': 'Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose', 'timeFrame': 'For 30 days after each dose (Up to Day 120)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.'}, {'measure': 'Rate of Seroconversion to Each of Four Dengue Serotypes', 'timeFrame': 'Up to 30 days after the last immunization (Up to Day 120)', 'description': 'Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations', 'timeFrame': 'various timepoints up to 30 days after each dose (Up to Day 120)', 'description': 'Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.'}, {'measure': 'Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes', 'timeFrame': 'Days 30, 90 and 120 after 1st vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety and immunogenicity of dengue vaccine'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.\n\nBlood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \\[during the screening period or on day of vaccination (Day 0)\\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \\[during the screening period or on day of vaccination (Day 0)\\], then on Days 30, 90 and 120.\n\nThe entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female at least 18 years and ≤ 45 years old at time of screening\n2. In good health as determined by medical history, physical examination including height and weight\n3. Normal clinical safety laboratory examinations \\[Sodium (Na), Potassium (K), Glucose, Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count, hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and urinalysis (by dipstick)\\].\n4. Weight: Body Mass Index (BMI) ≤32\n5. Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen\n\nExclusion Criteria:\n\n1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator\n2. Clinically significant ECG findings\n3. History of any significant dermatologic disease in the last 6 months,\n4. History of diabetes mellitus\n5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines\n6. Hypersensitivity to any vaccine\n7. Receipt of any vaccine in the 4 weeks preceding the first vaccination\n8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study\n9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)\n10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)\n11. Seropositivity to dengue or West Nile (WN) virus\n12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months\n13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed\n14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination\n15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)\n16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids\n17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90\n18. Females who are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT01542632', 'briefTitle': 'A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years', 'orgStudyIdInfo': {'id': 'INV-DEN-104'}, 'secondaryIdInfos': [{'id': 'U1111-1177-8166', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.", 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90.', 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.', 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)"]}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.', 'interventionNames': ['Biological: TDV New Formulation', 'Drug: New Formulation Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.', 'interventionNames': ['Biological: TDV New Formulation', 'Drug: New Formulation Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': '1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.', 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)"]}], 'interventions': [{'name': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'type': 'BIOLOGICAL', 'description': 'TDV subcutaneous injection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 6']}, {'name': 'TDV New Formulation', 'type': 'BIOLOGICAL', 'description': 'TDV New Formulation subcutaneous injection', 'armGroupLabels': ['Group 4', 'Group 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous injection', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'New Formulation Placebo', 'type': 'DRUG', 'description': 'New Formulation placebo subcutaneous injection', 'armGroupLabels': ['Group 4', 'Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Heart Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Gilad Gordon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inviragen Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}