Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT05201794
Status:
TERMINATED
Last Update Posted:
2025-07-31
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of JNJ-64281802 for the Prevention of Dengue Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Vietnam'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Medical Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90)', 'description': "All Cause Mortality: Randomized analysis set included all HHC participants who were randomized in the study. Serious and Other AEs: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Per plan, safety data collection and analysis was not performed for index case. Although dosing stopped at Day 28, safety data through Day 50 were included in the DB prophylactic phase due to the drug's extended half-life (\\~10 days).", 'eventGroups': [{'id': 'EG000', 'title': 'DB Prophylactic Phase: JNJ-64281802: High Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 283, 'otherNumAffected': 107, 'seriousNumAtRisk': 282, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 283, 'otherNumAffected': 106, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DB Prophylactic Phase: Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 285, 'otherNumAffected': 109, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Follow-up Phase: JNJ-64281802: High Dose Regimen', 'description': 'After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 9, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Follow-up Phase: JNJ-64281802: Low Dose Regimen', 'description': 'After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 6, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Follow-up Phase: Placebo', 'description': 'After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 8, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 67}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'seriousEvents': [{'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertensive Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Crush Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 69, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.1409', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '67.3', 'ciLowerLimit': '15.2', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}, {'pValue': '=0.1418', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '67.2', 'ciLowerLimit': '14.9', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \\[RT-PCR\\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \\[PCR\\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \\[\\>=\\] 11 relative units per milliliter \\[RU/mL\\]).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set(PAS): all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on target not detected \\[TND\\] results for DENV RNA assay and if available, negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0192', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '87.8', 'ciLowerLimit': '58.1', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}, {'pValue': '=0.1131', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '62.9', 'ciLowerLimit': '20', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for \\>=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result \\>=11 RU/mL).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete analysis set: All participants included in PAS or secondary analysis set (SAS) (all randomized participants who received at least 1 dose of study intervention, had evidence of DENV infection \\[based on positive results for DENV RNA or NS1 protein assays at baseline\\] but without DENV signs and symptoms at baseline). As pre-planned, data collection and analysis was not performed for index case.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0302', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '85.4', 'ciLowerLimit': '62.6', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}, {'pValue': '=0.2239', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '80', 'paramValue': '60.5', 'ciLowerLimit': '-6.3', 'pValueComment': 'One-sided p-value', 'estimateComment': '1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).', 'groupDescription': 'The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.', 'statisticalMethod': 'Exact logistic regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for \\>=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result \\>=11 RU/mL).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants who received at least 1 dose of study intervention, who had no evidence of DENV infection at baseline (based on TND\\] results for DENV RNA assay and, if available, a negative/borderline result for NS1 protein assays) and with at least 1 result for DENV RNA or NS1 protein assay available post baseline up to and including the last day of dosing + 1 day. As pre-planned, data collection and analysis was not performed for index case.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}, {'value': '284', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Prophylactic Phase: JNJ-64281802: High Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.'}, {'id': 'OG001', 'title': 'DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.'}, {'id': 'OG002', 'title': 'DB Prophylactic Phase: Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended up to Day 50 considering the long half-life (\\~10 days) of the study intervention.'}, {'id': 'OG003', 'title': 'Follow-up Phase: JNJ-64281802: High Dose Regimen', 'description': 'After completion of DB prophylactic dosing phase, participants who received high dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG004', 'title': 'Follow-up Phase: JNJ-64281802: Low Dose Regimen', 'description': 'After completion of DB prophylactic dosing phase, participants who received low dose of JNJ-64281802 in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG005', 'title': 'Follow-up Phase: Placebo', 'description': 'After completion of DB prophylactic dosing phase, participants who received placebo (matching to JNJ-64281802) in DB prophylactic dosing phase entered follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study intervention. As pre-planned, data collection and analysis was not performed for index case.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of drug administration (DB prophylactic Day 1) up to Day 50', 'description': 'Vital signs: pulse and blood pressure (systolic blood pressure\\[SBP\\]/diastolic blood pressure\\[DBP\\]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury\\[mmHg\\]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (\\>)150-155, G3(severe):\\>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (\\<)85, G3(severe):\\<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):\\>95-100, G3(severe):\\>100; Pulse(beats per minutes\\[bpm\\]):Tachycardia: G1(mild):\\>100-115, G2(moderate):\\>115-130, G3(severe):\\>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):\\<50-45, G3(severe):\\<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Only parameter (SBP: Hypertension) in which at least 1 participant had data was reported. As pre-planned, data collection and analysis was not performed for index case."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'title': 'Heart Rate: Abnormally Low (<45)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, Aggregate: Abnormally High (>=220)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'PR Interval, Aggregate: Abnormally Low (<110)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'QTcB Interval, Aggregate: Borderline prolonged QT (450< QTc <=480)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QTcF Interval, Aggregate: Borderline prolonged QT (450< QTc <=480)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'QRS Duration, Aggregate: Abnormally High (>=120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': "ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: \\< 45, high: \\>=120; PR Interval (milliseconds \\[ms\\]): low: \\<110, high: \\>=220; QRS interval (ms): high: \\>=120; QTcB and QTcF (ms): Borderline prolonged QT: 450\\< QTc \\<=480, 480 \\<QTc \\<=500, QTc \\>500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'title': 'Hematology: Hemoglobin, Low: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: Hemoglobin, Low: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: Activated partial thromboplastin time (APTT), High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: APTT, High: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: Prothrombin time (PT), High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: PT, High: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hematology: Platelets, Decrease: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hyperglycemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypoglycemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypoglycemia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Triglycerides (Fasting), High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Cholesterol, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Low density lipoprotein (Fasting), High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypernatremia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Creatine Kinase, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Creatine Kinase, High: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Alanine aminotransferase or Serum glutamic pyruvic transaminase (SGPT), High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Uric Acid, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hyperkalemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypokalemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Gamma Glutamyl Transferase, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Amylase (Pancreatic), High: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypophosphatemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Aspartate aminotransferase or Serum glutamic-oxaloacetic transaminase, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hyperbilirubinemia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypercalcemia: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Hypocalcemia: Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chemistry: Lipase, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Urinalysis: Protein, High: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Urinalysis: Glycosuria: Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of drug administration (DB prophylactic Day 1) up to Day 50', 'description': 'Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified rows. Only those parameters in which at least 1 participant had data was reported in this outcome measure. As pre-planned, data collection and analysis was not performed for index case."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 50', 'description': "Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who received at least 1 dose of study intervention. Here, 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure. As pre-planned, data collection and analysis was not performed for index case."}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of JNJ-64281802', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'OG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}], 'classes': [{'title': 'Pre-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '31.52', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '69.03', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4233.5', 'spread': '1534.79', 'groupId': 'OG000'}, {'value': '1777.1', 'spread': '732.09', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2735.0', 'spread': '1370.95', 'groupId': 'OG000'}, {'value': '1037.1', 'spread': '505.93', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2583.1', 'spread': '1311.77', 'groupId': 'OG000'}, {'value': '909.1', 'spread': '469.41', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2657.4', 'spread': '1380.73', 'groupId': 'OG000'}, {'value': '865.8', 'spread': '439.79', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2649.4', 'spread': '1606.28', 'groupId': 'OG000'}, {'value': '846.9', 'spread': '495.83', 'groupId': 'OG001'}]}]}, {'title': 'Post-dose on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2614.1', 'spread': '1653.06', 'groupId': 'OG000'}, {'value': '816.1', 'spread': '535.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1194.8', 'spread': '858.11', 'groupId': 'OG000'}, {'value': '325.4', 'spread': '238.77', 'groupId': 'OG001'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '640.2', 'spread': '543.84', 'groupId': 'OG000'}, {'value': '165.4', 'spread': '143.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.3', 'spread': '82.76', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '18.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90', 'description': 'Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.', 'unitOfMeasure': 'Nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic analysis set included all participants who received at least 1 dose of study intervention and who had at least 1 plasma concentration data value after dosing. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure, 'n' (number analyzed) refers to all participants evaluable at specified time points. Data for this outcome measure was planned to be collected and analyzed for specified arms only."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'FG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'FG003', 'title': 'Index Case Participants', 'description': 'Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '283'}, {'groupId': 'FG002', 'numSubjects': '285'}, {'groupId': 'FG003', 'numSubjects': '411'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '281'}, {'groupId': 'FG002', 'numSubjects': '284'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants Who Entered Into Follow-up Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '252'}, {'groupId': 'FG003', 'numSubjects': '411'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol-Specified Withdrawal Criterion Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-Compliance With Study Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Site Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized But Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Of 1595 enrolled participants (those who signed informed consent form \\[ICF\\]): 616 were index cases, 979 were household contacts (HHCs) identified from index cases. Of 616, 411 met the eligibility criteria for index case population (those who signed ICF and had a laboratory-confirmed dengue infection) and are reported below. Out of 979 HHCs, 128 were screen failures. Per plan, index cases were not included in any analysis and 851 randomized HHCs were included in the analysis.', 'preAssignmentDetails': "HHCs included family members, acquaintances, co-workers, and community contacts, who were asymptomatic at screening (no clinical dengue symptoms). For safety assessments, although dosing stopped at Day 28, safety data through Day 50 were included in double-blind (DB) prophylactic phase due to drug's extended half-life (\\~10 days)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '411', 'groupId': 'BG003'}, {'value': '1258', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'JNJ-64281802: High Dose Regimen', 'description': 'During the double-blind (DB) prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 400 milligrams (mg) tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 150 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'BG001', 'title': 'JNJ-64281802: Low Dose Regimen', 'description': 'During the DB prophylactic dosing phase, HHC participants received loading dose of JNJ-64281802 150 mg tablet orally twice daily for 48 hours (Day 1 and 2) followed by maintenance dose of JNJ-64281802 50 mg tablet orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'During the DB prophylactic dosing phase, HHC participants received placebo (matching to JNJ-64281802) tablet orally twice daily for 48 hours (Day 1 and 2) followed by orally once daily for 26 days (from Day 3 to 28) in fed conditions. After Day 28, the prophylactic dosing phase was extended to Day 50 considering the long half-life (\\~10 days) of the study intervention. Participants then entered the follow-up phase and were followed up for safety up to Day 90 (end of trial).'}, {'id': 'BG003', 'title': 'Index Case Participants', 'description': 'Index case included all enrolled (on Day 1) participants who were with laboratory-confirmed dengue infection and contributed HHC participants. These index case participants were not randomized to receive study intervention.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '12.07', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '11.67', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '11.57', 'groupId': 'BG002'}, {'value': '28.2', 'spread': '16.54', 'groupId': 'BG003'}, {'value': '32.3', 'spread': '13.81', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}, {'value': '664', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}, {'value': '593', 'groupId': 'BG004'}]}, {'title': 'Undifferentiated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}, {'value': '312', 'groupId': 'BG003'}, {'value': '1016', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '643', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '217', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '189', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '502', 'groupId': 'BG004'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '177', 'groupId': 'BG004'}]}]}, {'title': 'Panama', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'For randomized HHC participants: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. For index case participants: Index case analysis set included all participants enrolled as an index case, with a laboratory-confirmed dengue virus (DENV) infection.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-19', 'size': 3325300, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-25T08:31', 'hasProtocol': True}, {'date': '2024-10-21', 'size': 1120183, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-25T08:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1595}}, 'statusModule': {'whyStopped': 'The study was stopped due to portfolio reprioritization. This decision is not based on any safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2022-01-10', 'resultsFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-30', 'studyFirstPostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \\[RT-PCR\\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \\[PCR\\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \\[\\>=\\] 11 relative units per milliliter \\[RU/mL\\])."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline)', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for \\>=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result \\>=11 RU/mL)."}, {'measure': 'Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline', 'timeFrame': 'Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)', 'description': "Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for \\>=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result \\>=11 RU/mL)."}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs', 'timeFrame': 'From start of drug administration (DB prophylactic Day 1) up to Day 50', 'description': 'Vital signs: pulse and blood pressure (systolic blood pressure\\[SBP\\]/diastolic blood pressure\\[DBP\\]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury\\[mmHg\\]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (\\>)150-155, G3(severe):\\>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (\\<)85, G3(severe):\\<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):\\>95-100, G3(severe):\\>100; Pulse(beats per minutes\\[bpm\\]):Tachycardia: G1(mild):\\>100-115, G2(moderate):\\>115-130, G3(severe):\\>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):\\<50-45, G3(severe):\\<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.'}, {'measure': 'Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Day 28', 'description': "ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: \\< 45, high: \\>=120; PR Interval (milliseconds \\[ms\\]): low: \\<110, high: \\>=220; QRS interval (ms): high: \\>=120; QTcB and QTcF (ms): Borderline prolonged QT: 450\\< QTc \\<=480, 480 \\<QTc \\<=500, QTc \\>500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent."}, {'measure': 'Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters', 'timeFrame': 'From start of drug administration (DB prophylactic Day 1) up to Day 50', 'description': 'Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Physical Examinations', 'timeFrame': 'Day 50', 'description': "Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion."}, {'measure': 'Plasma Concentrations of JNJ-64281802', 'timeFrame': 'Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90', 'description': 'Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dengue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents\n* Must have a body mass index (BMI, weight in kilogram \\[kg\\] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m\\^2) inclusive, and a body weight of greater than or equal to (\\>=) 40.0 kg at screening\n* A woman must have a negative highly sensitive urine pregnancy test at screening\n* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for \\>= 90 days after receiving the last dose of study intervention\n* Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Having any dengue virus (DENV)-associated clinical signs and symptoms\n* Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients\n* Any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria\n* Reduced immune function to be: (a) Known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy)\n* Received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 \\[COVID-19\\] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study"}, 'identificationModule': {'nctId': 'NCT05201794', 'briefTitle': 'A Study of JNJ-64281802 for the Prevention of Dengue Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for the Prevention of Dengue Infection', 'orgStudyIdInfo': {'id': 'CR109157'}, 'secondaryIdInfos': [{'id': '64281802DNG2004', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose JNJ-64281802 regimen (HDR)', 'description': 'Participants will receive JNJ-64281802 400 milligrams (mg) loading dose (LD) twice daily for 48 hours (2 days), followed by JNJ-64281802 150 mg maintenance dose (MD) once daily for 26 days in fed conditions.', 'interventionNames': ['Drug: JNJ-64281802']}, {'type': 'EXPERIMENTAL', 'label': 'Low-dose JNJ-64281802 regimen (LDR)', 'description': 'Participants will receive JNJ-64281802 150 mg LD twice daily for 48 hours (2 days), followed by JNJ-64281802 50 mg MD once daily for 26 days in fed conditions.', 'interventionNames': ['Drug: JNJ-64281802']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'JNJ-64281802', 'type': 'DRUG', 'description': 'JNJ-64281802 tablets will be administered orally as per the defined regimens.', 'armGroupLabels': ['High-dose JNJ-64281802 regimen (HDR)', 'Low-dose JNJ-64281802 regimen (LDR)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo for each dose level as tablet will be administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31270901', 'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'Universidade Federal De Minas Gerais - 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