Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-02 @ 6:19 AM
Study NCT ID:
NCT04068792
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624632', 'term': 'JNJ-53718678'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior director 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The required number of participants in the interventional phase was not reached, and hence, limiting the interpretability of the data.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 31', 'description': "The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis Atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis Diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Respiratory Syncytial Virus Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '26.13', 'spread': '23.701', 'groupId': 'OG000', 'lowerLimit': '23.701', 'upperLimit': '28.555'}, {'value': '25.10', 'spread': '22.497', 'groupId': 'OG001', 'lowerLimit': '22.497', 'upperLimit': '27.707'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.03', 'ciLowerLimit': '-4.467', 'ciUpperLimit': '2.416', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) up to Day 5', 'description': 'RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.', 'unitOfMeasure': 'log10 copies*day per milliliter', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat-infected (ITT-i) analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of greater than or equal to (\\>=) 1 log10 copies per milliliter (mL) above the lower limit of quantification (LLOQ) of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized.'}, {'type': 'SECONDARY', 'title': 'RSV Viral Load Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.744', 'spread': '1.1991', 'groupId': 'OG000'}, {'value': '7.477', 'spread': '1.4111', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.748', 'spread': '1.2387', 'groupId': 'OG000'}, {'value': '6.613', 'spread': '3.2426', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.415', 'spread': '2.3924', 'groupId': 'OG000'}, {'value': '6.277', 'spread': '2.8027', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.600', 'spread': '2.2868', 'groupId': 'OG000'}, {'value': '5.683', 'spread': '3.2009', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.105', 'spread': '1.3664', 'groupId': 'OG000'}, {'value': '5.287', 'spread': '2.0195', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.335', 'spread': '2.3774', 'groupId': 'OG000'}, {'value': '4.023', 'spread': '2.8076', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.953', 'spread': '1.0500', 'groupId': 'OG000'}, {'value': '3.624', 'spread': '2.4153', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.020', 'spread': '0.9431', 'groupId': 'OG000'}, {'value': '2.924', 'spread': '2.1366', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.145', 'spread': '1.8643', 'groupId': 'OG000'}, {'value': '2.666', 'spread': '2.1545', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.657', 'spread': '1.9192', 'groupId': 'OG000'}, {'value': '3.035', 'spread': '2.2622', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.598', 'spread': '1.6655', 'groupId': 'OG000'}, {'value': '3.059', 'spread': '2.6895', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.967', 'spread': '1.6743', 'groupId': 'OG000'}, {'value': '3.417', 'spread': '3.4191', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.352', 'spread': '2.3700', 'groupId': 'OG000'}, {'value': '2.020', 'spread': '2.4599', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.837', 'spread': '1.9135', 'groupId': 'OG000'}, {'value': '0.883', 'spread': '1.3426', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21', 'description': 'RSV viral load actual values over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.', 'unitOfMeasure': 'log10 copies per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in RSV Viral Load Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.9247', 'groupId': 'OG000'}, {'value': '-0.797', 'spread': '1.8465', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.329', 'spread': '2.3903', 'groupId': 'OG000'}, {'value': '-1.293', 'spread': '1.6220', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.002', 'spread': '2.7624', 'groupId': 'OG000'}, {'value': '-1.857', 'spread': '1.9805', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.638', 'spread': '1.4728', 'groupId': 'OG000'}, {'value': '-2.222', 'spread': '1.4063', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.391', 'spread': '2.8796', 'groupId': 'OG000'}, {'value': '-3.153', 'spread': '1.5444', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.667', 'spread': '1.8529', 'groupId': 'OG000'}, {'value': '-3.552', 'spread': '1.1919', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.630', 'spread': '1.5622', 'groupId': 'OG000'}, {'value': '-4.634', 'spread': '1.6078', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.046', 'spread': '1.8708', 'groupId': 'OG000'}, {'value': '-5.564', 'spread': '2.2160', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.782', 'spread': '2.3406', 'groupId': 'OG000'}, {'value': '-5.195', 'spread': '2.3057', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.580', 'spread': '1.8008', 'groupId': 'OG000'}, {'value': '-5.263', 'spread': '2.7523', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.225', 'spread': '0.9469', 'groupId': 'OG000'}, {'value': '-4.905', 'spread': '3.4450', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.439', 'spread': '2.0248', 'groupId': 'OG000'}, {'value': '-5.588', 'spread': '2.7565', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.907', 'spread': '1.6829', 'groupId': 'OG000'}, {'value': '-6.514', 'spread': '1.5001', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21', 'description': 'Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.', 'unitOfMeasure': 'log10 copies per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here, 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.44', 'groupId': 'OG000', 'lowerLimit': '12.841', 'upperLimit': '16.042'}, {'value': '13.70', 'groupId': 'OG001', 'lowerLimit': '11.990', 'upperLimit': '15.406'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.20', 'groupId': 'OG000', 'lowerLimit': '34.913', 'upperLimit': '43.491'}, {'value': '35.11', 'groupId': 'OG001', 'lowerLimit': '31.342', 'upperLimit': '38.880'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Days 3, 8, and 14', 'description': 'RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens.', 'unitOfMeasure': 'log10 copies*hour per milliliter (h/mL)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. At Day 14, data was not collected due to low sample size."}, {'type': 'SECONDARY', 'title': 'Time to Undetectable RSV Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '500.1', 'comment': "'NA' refers that upper limit of confidence interval was not estimable due to low sample size, and censoring.", 'groupId': 'OG000', 'lowerLimit': '239.90', 'upperLimit': 'NA'}, {'value': '391.4', 'groupId': 'OG001', 'lowerLimit': '185.50', 'upperLimit': '526.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 21 days', 'description': 'Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post-baseline time point at which the virus is confirmed undetectable. A confirmed undetectable sample is defined as the first of at least two consecutive samples that are undetectable. The last obtained sample for a participant, if undetectable, is considered confirmed.', 'unitOfMeasure': 'hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21', 'description': 'Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.345', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.527', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.535', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.610', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.456', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.398', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.461', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.285', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.323', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.053', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 3, 5, 8, 14, and 21', 'description': 'The severity of signs and symptoms of RSV infection (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) were assessed by the PRESORS. PRESORS is a questionnaire by parent(s)/caregiver(s) recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.', 'unitOfMeasure': 'Unit on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.341', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.249', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.309', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.437', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.314', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.508', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.396', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.396', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.408', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.390', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 5, 8, 14, 21', 'description': 'PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinician PRESORS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.287', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.212', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.291', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.151', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.192', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.276', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 5, 8, 14, 21', 'description': 'Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 10-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \\>=1 log10 copies per mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure; 'n' (number analyzed) included all participants who were analyzed at specified timepoints for specific category."}, {'type': 'SECONDARY', 'title': 'Time to Resolution of RSV Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '194.00', 'groupId': 'OG000', 'lowerLimit': '164.20', 'upperLimit': '238.00'}, {'value': '118.60', 'groupId': 'OG001', 'lowerLimit': '17.00', 'upperLimit': '238.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 21 days', 'description': 'Time to resolution from first dose of study drug until the first time of resolution of all RSV Symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.', 'unitOfMeasure': 'Hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement on Overall Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '188.3', 'groupId': 'OG000', 'lowerLimit': '183.60', 'upperLimit': '238.00'}, {'value': '199.7', 'groupId': 'OG001', 'lowerLimit': '183.70', 'upperLimit': '238.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 21 days', 'description': 'Time to improvement based on general questions on overall health was reported. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question \'Would you say the child\'s RSV symptoms have improved, are about the same or are worse than when the child entered the study\'.', 'unitOfMeasure': 'Hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Worsening or Improvement of RSV Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'Day 2 : Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 4: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 4: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 6: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 9: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 9: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 10: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 10 Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11 Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 11: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 12 Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 12: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 13 Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 13: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 15: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 16: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 17: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 17: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 18: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 19: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 20: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Very Much Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '77.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 21: Very Much Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21', 'description': 'Percentage of participants with worsening or improvement of RSV disease based on general questions on overall health was reported. Improvement is defined improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question \'Would you say the child\'s RSV symptoms have improved, are about the same or are worse than when the child entered the study\'.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \\>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'timeFrame': 'Up to 21 days', 'description': 'Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected due to low number of participants. Hence, no results are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants who require (re)hospitalization during treatment and follow-up were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Safety set (SAF) included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Chemistry Laboratory Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'ALT Increase - Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT Increase - Grade 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST- Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia - Grade 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia - Grade 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with abnormal chemistry laboratory findings (alanine aminotransferase \\[ALT; Grade 1 and 4\\], aspartate aminotransferase \\[AST; Grade 1\\], and Hyperkalemia \\[Grade 1 and 2\\]) were reported based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed at specified categories."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Urinalysis Laboratory Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'QTcB Interval (450 ms, 480 ms)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'QTcB Interval (480 ms, 500 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcB Interval (More than 500 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (450 ms, 480 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (480 ms, 500 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (More than 500 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcB Interval (30; 60) ms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'QTcB Interval (>60 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (30; 60) ms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval (>60 ms)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': "Percentage of participants with abnormal ECGs findings were reported. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB) Interval (\\[450 milliseconds {ms}, 480 ms\\], \\[480 ms, 500 ms\\], and \\[more than 500 ms\\]), QTc according to Fridericia's formula (QTcF) Interval (\\[450 ms, 480 ms\\], \\[480 ms, 500 ms\\], and \\[more than 500 ms\\]), change from baseline for QTcB Interval (\\[30; 60\\] ms, and greater than \\[\\>\\] 60 ms), and for QTcF Interval (\\[30; 60\\] ms, and \\>60 ms).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vital Sign Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'classes': [{'title': 'SBP- ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP- ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP- ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP- ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate- ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate- ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate-ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory Rate-ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Temperature-ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Temperature-ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Oxygen Saturation- ABL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Oxygen Saturation- ABH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with vital signs (systolic blood pressure \\[SBP\\], diastolic blood pressure \\[DBP\\], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation \\[SpO2\\]) abnormalities (abnormally low \\[ABL\\] and abnormally high \\[ABH\\]) were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed for specified categories."}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of JNJ-53718678', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'OG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'timeFrame': 'Day 1 and Day 3', 'description': 'No data was collected for pharmacokinetic (PK) analysis due to small sample size. Hence, no results are reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for PK analysis due to small sample size. Hence, no results are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'FG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \\[greater than or equal to {\\>=} 28 days and less than {\\<} 3 months\\], for Age Group 2 \\[\\>=3 and \\<6 months\\], and for Age Group 3 \\[\\>=6 months\\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.'}, {'id': 'BG001', 'title': 'JNJ-53718678', 'description': 'As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \\[\\>= 28 days and \\< 3 months\\]: 5 milligrams/kilogram \\[mg/kg\\]; for Age Group 2 \\[\\>=3 and \\<6 months\\]: 6 mg/kg and for Age Group 3 \\[\\>=6 months\\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '1.962', 'groupId': 'BG000'}, {'value': '3.18', 'spread': '1.343', 'groupId': 'BG001'}, {'value': '3.64', 'spread': '1.707', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Panama', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, Province Of China', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-13', 'size': 2603898, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-12T10:49', 'hasProtocol': True}, {'date': '2021-06-02', 'size': 1740973, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-12T10:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2019-08-23', 'resultsFirstSubmitDate': '2022-05-12', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-12', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])', 'timeFrame': 'Baseline (Day 1) up to Day 5', 'description': 'RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.'}], 'secondaryOutcomes': [{'measure': 'RSV Viral Load Over Time', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21', 'description': 'RSV viral load actual values over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.'}, {'measure': 'Change From Baseline in RSV Viral Load Over Time', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21', 'description': 'Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.'}, {'measure': 'RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14', 'timeFrame': 'Baseline through Days 3, 8, and 14', 'description': 'RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens.'}, {'measure': 'Time to Undetectable RSV Viral Load', 'timeFrame': 'Up to 21 days', 'description': 'Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post-baseline time point at which the virus is confirmed undetectable. A confirmed undetectable sample is defined as the first of at least two consecutive samples that are undetectable. The last obtained sample for a participant, if undetectable, is considered confirmed.'}, {'measure': 'Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study', 'timeFrame': 'Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21', 'description': 'Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported.'}, {'measure': 'Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)', 'timeFrame': 'Baseline, Days 3, 5, 8, 14, and 21', 'description': 'The severity of signs and symptoms of RSV infection (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) were assessed by the PRESORS. PRESORS is a questionnaire by parent(s)/caregiver(s) recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.'}, {'measure': 'Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores', 'timeFrame': 'Baseline, Day 3, 5, 8, 14, 21', 'description': 'PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.'}, {'measure': 'Change From Baseline in Clinician PRESORS Score', 'timeFrame': 'Baseline, Day 3, 5, 8, 14, 21', 'description': 'Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 10-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.'}, {'measure': 'Time to Resolution of RSV Symptoms', 'timeFrame': 'Up to 21 days', 'description': 'Time to resolution from first dose of study drug until the first time of resolution of all RSV Symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.'}, {'measure': 'Time to Improvement on Overall Health', 'timeFrame': 'Up to 21 days', 'description': 'Time to improvement based on general questions on overall health was reported. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question \'Would you say the child\'s RSV symptoms have improved, are about the same or are worse than when the child entered the study\'.'}, {'measure': 'Percentage of Participants With Worsening or Improvement of RSV Disease', 'timeFrame': 'On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21', 'description': 'Percentage of participants with worsening or improvement of RSV disease based on general questions on overall health was reported. Improvement is defined improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question \'Would you say the child\'s RSV symptoms have improved, are about the same or are worse than when the child entered the study\'.'}, {'measure': 'Time to Return to Pre-RSV Health as Rated by the Parent(s)/Caregiver(s)', 'timeFrame': 'Up to 21 days', 'description': 'Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level.'}, {'measure': 'Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants who require (re)hospitalization during treatment and follow-up were reported.'}, {'measure': 'Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Up to Day 31', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}, {'measure': 'Percentage of Participants With Abnormal Chemistry Laboratory Findings', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with abnormal chemistry laboratory findings (alanine aminotransferase \\[ALT; Grade 1 and 4\\], aspartate aminotransferase \\[AST; Grade 1\\], and Hyperkalemia \\[Grade 1 and 2\\]) were reported based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.'}, {'measure': 'Percentage of Participants With Abnormal Urinalysis Laboratory Findings', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.'}, {'measure': 'Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings', 'timeFrame': 'Up to Day 31', 'description': "Percentage of participants with abnormal ECGs findings were reported. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB) Interval (\\[450 milliseconds {ms}, 480 ms\\], \\[480 ms, 500 ms\\], and \\[more than 500 ms\\]), QTc according to Fridericia's formula (QTcF) Interval (\\[450 ms, 480 ms\\], \\[480 ms, 500 ms\\], and \\[more than 500 ms\\]), change from baseline for QTcB Interval (\\[30; 60\\] ms, and greater than \\[\\>\\] 60 ms), and for QTcF Interval (\\[30; 60\\] ms, and \\>60 ms)."}, {'measure': 'Percentage of Participants With Vital Sign Abnormalities', 'timeFrame': 'Up to Day 31', 'description': 'Percentage of participants with vital signs (systolic blood pressure \\[SBP\\], diastolic blood pressure \\[DBP\\], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation \\[SpO2\\]) abnormalities (abnormally low \\[ABL\\] and abnormally high \\[ABH\\]) were reported.'}, {'measure': 'Plasma Concentrations of JNJ-53718678', 'timeFrame': 'Day 1 and Day 3', 'description': 'No data was collected for pharmacokinetic (PK) analysis due to small sample size. Hence, no results are reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Viruses']}, 'descriptionModule': {'briefSummary': 'The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory Syncytial Virus (RSV) fusion inhibitor, JNJ-53718678 (interventional stage). In the observational stage the infant is closely monitored for early symptoms by the parent(s)/caregiver(s) and thus may be brought in for diagnosis earlier than in the typical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPart 1: Observational Stage\n\n* The infant is less than or equal to (\\<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study\n* At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)\n* The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\n\nPart 2: Interventional Stage\n\n* The infant is 28 days and if prematurely born infant (that is \\[i.e.\\], less than \\[\\<\\] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age\n* The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay\n* The participant weighs more than 2.4 kilogram (kg)\n* The participant has an acute respiratory illness as evaluated by the investigator\n* Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions\n* The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection\n\nExclusion Criteria:\n\nPart 1: Observational Stage\n\n* The participant has any physical abnormality which limits the ability to collect regular nasal specimens\n* The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)\n\nPart 2: Interventional Stage\n\n* The participant is \\<3 months postnatal age at screening and was born prematurely (i.e., \\<37 weeks and 0 days of gestation) or if the participant weights \\<2.4 kg\n* The participant has a QT interval with Fridericia's correction (QTcF) greater than (\\>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening\n* The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy\n* The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization"}, 'identificationModule': {'nctId': 'NCT04068792', 'briefTitle': 'A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV', 'orgStudyIdInfo': {'id': 'CR108647'}, 'secondaryIdInfos': [{'id': '2019-001509-25', 'type': 'EUDRACT_NUMBER'}, {'id': '53718678RSV2006', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Part 1-Observational Phase', 'description': "Participants will not receive any intervention in the observation phase. All infants will be closely monitored for early signs and symptoms of Respiratory Syncytial Virus (RSV) disease using a mobile RSV application on the parent/caregiver's mobile phone, upon an alert, the RSV will be tested, if RSV negative participants (RSV \\[-\\] diagnosed at site) will return to the pre-diagnostic phase and RSV positive participants (RSV \\[+\\] diagnosed at site) can be enrolled in the interventional stage of the study after obtaining informed consent for the interventional stage at that time. RSV (+) participants whose parent(s)/caregiver(s) do not consent for enrollment in the interventional stage and participants who are screening failures in the interventional stage will enter the post-diagnostic phase of the observational stage (hospitalized or outpatients).", 'interventionNames': ['Other: RSV Mobile Application']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2-Interventional Phase', 'description': 'Participants will be randomized to receive either JNJ-53718678 (for Age Group 1 (greater than or equal to \\[\\>=\\] 28 days and less than \\[\\<\\] 3 months): 2.5 milligram per kilogram \\[mg/kg\\]; for Age Group 2 (\\>=3 and \\<6 months): 3 mg/kg and for Age Group 3 (\\>=6 months): 4.5 mg/kg) or placebo (Age Group 1, 2 and 3) twice daily for 7 days.', 'interventionNames': ['Drug: Placebo', 'Drug: JNJ-53718678 2.5 mg/kg', 'Drug: JNJ-53718678 3 mg/kg', 'Drug: JNJ-53718678 4.5 mg/kg']}], 'interventions': [{'name': 'RSV Mobile Application', 'type': 'OTHER', 'description': "Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.", 'armGroupLabels': ['Part 1-Observational Phase']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.', 'armGroupLabels': ['Part 2-Interventional Phase']}, {'name': 'JNJ-53718678 2.5 mg/kg', 'type': 'DRUG', 'description': 'JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.', 'armGroupLabels': ['Part 2-Interventional Phase']}, {'name': 'JNJ-53718678 3 mg/kg', 'type': 'DRUG', 'description': 'JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.', 'armGroupLabels': ['Part 2-Interventional Phase']}, {'name': 'JNJ-53718678 4.5 mg/kg', 'type': 'DRUG', 'description': 'JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.', 'armGroupLabels': ['Part 2-Interventional Phase']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Instituto de Maternidad y GinecologĂa Nuestra Senora de las Mercedes', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '000000', 'city': 'Panama City', 'country': 'Panama', 'facility': 'Cevaxin 24 de diciembre', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '000000', 'city': 'Panama City', 'country': 'Panama', 'facility': 'Cevaxin Avenida Mexico', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '000000', 'city': 'Republica de Panama', 'country': 'Panama', 'facility': 'Cevaxin La Chorrera'}, {'zip': '30071', 'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'Hsinchu MacKay Memorial Hospital', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10449', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Pediatrics, MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital- Linkou', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's University Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}