Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03524118
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721494', 'term': 'MK-1654'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Clinical Trials Disclosure', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 545', 'description': 'All-cause mortality was analyzed in all randomized participants. AEs were analyzed in all participants who received at least one dose of study treatment. Additionally, two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1654 20 mg in Pre-term Infants', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MK-1654 50 mg in Pre-term Infants', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 31, 'otherNumAffected': 29, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'MK-1654 75 mg in Pre-term Infants', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 41, 'otherNumAffected': 29, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'MK-1654 100 mg Pre-Term Infants', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 26, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'MK-1654 100 mg Full-Term Infants', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 33, 'otherNumAffected': 29, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 33, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 22, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 19, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 52, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 22, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Biliary cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Irregular breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.'}], 'classes': [{'title': 'with solicited injection site adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'without solicited injection site adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 5', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.'}], 'classes': [{'title': 'with solicited systemic adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'without solicited systemic adverse events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 5', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.'}], 'classes': [{'title': 'with serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'without SAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 545', 'description': 'An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population consisted of all participants who received at least one dose of study treatment. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified safety analysis population.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '1560', 'spread': '43.5', 'groupId': 'OG000'}, {'value': '3520', 'spread': '22.8', 'groupId': 'OG001'}, {'value': '5510', 'spread': '22.4', 'groupId': 'OG002'}, {'value': '6790', 'spread': '25.4', 'groupId': 'OG003'}, {'value': '5690', 'spread': '15.9', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.', 'unitOfMeasure': 'day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of Clesrovimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '94.5', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '117', 'spread': '23.5', 'groupId': 'OG003'}, {'value': '99.9', 'spread': '13.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'Cmax is the highest observed serum drug concentration.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Serum Concentration (Tmax) of Clesrovimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '4.60'}, {'value': '4.20', 'groupId': 'OG001', 'lowerLimit': '3.70', 'upperLimit': '5.30'}, {'value': '4.20', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '5.80'}, {'value': '4.10', 'groupId': 'OG003', 'lowerLimit': '3.70', 'upperLimit': '6.00'}, {'value': '4.10', 'groupId': 'OG004', 'lowerLimit': '3.70', 'upperLimit': '4.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-life (t1/2) of Clesrovimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '34.6', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '46.1', 'spread': '15.1', 'groupId': 'OG002'}, {'value': '45.2', 'spread': '13.7', 'groupId': 'OG003'}, {'value': '43.0', 'spread': '9.72', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 't1/2 is the time required for 50% of drug to be cleared from serum.', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Clesrovimab on Day 7 (C7days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '88.1', 'spread': '20.4', 'groupId': 'OG002'}, {'value': '109', 'spread': '23.0', 'groupId': 'OG003'}, {'value': '92.8', 'spread': '13.3', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7', 'description': 'Serum concentration of clesrovimab was measured on Day 7.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Clesrovimab on Day 14 (C14days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '20.6', 'groupId': 'OG001'}, {'value': '71.1', 'spread': '19.7', 'groupId': 'OG002'}, {'value': '88.6', 'spread': '21.8', 'groupId': 'OG003'}, {'value': '75.4', 'spread': '12.9', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14', 'description': 'Serum concentration of clesrovimab was measured on Day 14.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Clesrovimab on Day 90 (C90days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.60', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '25.4', 'groupId': 'OG001'}, {'value': '20.4', 'spread': '25.8', 'groupId': 'OG002'}, {'value': '25.2', 'spread': '28.6', 'groupId': 'OG003'}, {'value': '21.1', 'spread': '18.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 90', 'description': 'Serum concentration of clesrovimab was measured on Day 90.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Clesrovimab on Day 150 (C150days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.24', 'spread': '80.6', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '34.2', 'groupId': 'OG001'}, {'value': '8.05', 'spread': '37.7', 'groupId': 'OG002'}, {'value': '9.70', 'spread': '40.2', 'groupId': 'OG003'}, {'value': '7.96', 'spread': '26.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 150', 'description': 'Serum concentration of clesrovimab was measured on Day 150.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of Clesrovimab on Day 365 (C365days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0953', 'spread': '362', 'groupId': 'OG000'}, {'value': '0.177', 'spread': '79.4', 'groupId': 'OG001'}, {'value': '0.313', 'spread': '107', 'groupId': 'OG002'}, {'value': '0.355', 'spread': '104', 'groupId': 'OG003'}, {'value': '0.248', 'spread': '63.1', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 365', 'description': 'Serum concentration of clesrovimab was measured on Day 365.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, with exclusions for important protocol deviations that may have substantially affected the results and with data available for this outcome measure. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50mg and were included in the MK-1654 50 mg group for the protocol specified PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'OG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'OG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'OG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}], 'classes': [{'title': 'ADA Negative status', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Non-treatment emergent positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'ADA Positive response to MK-1654', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Maximum Postdose Titer of 20 to < 189 of ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Maximum Postdose Titer of 189 to < 1077.5 of ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Maximum Postdose Titer of 1077.5 to < 9285 of ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Maximum Postdose Titer of 9285 to 160000 of ADA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 14, 90, 150, 365 and 545', 'description': 'ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment and were evaluable with at least one ADA result after treatment with MK-1654. Two participants who were randomized to the MK-1654 Panel A 20 mg dose group actually received MK-1654 Panel B 50 mg and were included in the MK-1654 50 mg group for the protocol specified immunogenicity analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'FG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'FG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'FG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants in Panel D1 and D2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'FG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants in Panel E1 and E2 received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days respectively.'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Safety Analysis Population', 'comment': 'Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '32'}, {'groupId': 'FG004', 'numSubjects': '32'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '183 participants were randomized and 181 were dosed and included in the All Participants as Treated (APaT) population. Two participants who were randomized to the MK-1654 20 mg dose group actually received MK-1654 50 mg and were included in the MK-1654 50 mg group for safety, pharmacokinetic (PK) and immunogenicity analyses.', 'preAssignmentDetails': 'Participants enrolled in panels D and E prior to protocol amendment 04 who chose not to participate in the modified schedule followed the D1 and E1 schedule of activities. Participants enrolled in panels D and E prior to protocol amendment 04 who chose to participate in the modified schedule followed the D2 and E2 schedule of activities.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '183', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A: Preterm Clesrovimab 20mg', 'description': 'Pre-term infants received clesrovimab 20mg via intramuscular (IM) injection and were followed for up to 365 days.'}, {'id': 'BG001', 'title': 'Panel B: Pre-term Clesrovimab 50mg', 'description': 'Pre-term infants received clesrovimab 50mg via IM injection and were followed for up to 365 days.'}, {'id': 'BG002', 'title': 'Panel C: Pre-term Clesrovimab 75mg', 'description': 'Pre-term infants received clesrovimab 75mg via IM injection and were followed for up to 365 days.'}, {'id': 'BG003', 'title': 'Panel D1 and D2: Pre-term Clesrovimab 100mg', 'description': 'Pre-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.'}, {'id': 'BG004', 'title': 'Panel E1 and E2: Full-term Clesrovimab 100mg', 'description': 'Full-term infants received clesrovimab 100mg via IM injection and were followed for up to 365 and 545 days.'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Pre-term and Full-term infants received placebo via IM injection.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '257'}, {'value': '109.0', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '255'}, {'value': '94.0', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '245'}, {'value': '139.5', 'groupId': 'BG003', 'lowerLimit': '14', 'upperLimit': '239'}, {'value': '164.0', 'groupId': 'BG004', 'lowerLimit': '46', 'upperLimit': '250'}, {'value': '128.0', 'groupId': 'BG005', 'lowerLimit': '26', 'upperLimit': '275'}, {'value': '126.0', 'groupId': 'BG006', 'lowerLimit': '14.0', 'upperLimit': '275'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'In utero', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Preterm newborn infants (gestational age < 37 wks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Newborns (0-27 days)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': 'Infants and toddlers (28 days-23 months)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '173', 'groupId': 'BG006'}]}]}, {'title': 'Children (2-11 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Adolescents (12-17 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'From 65-84 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '90', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '79', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '104', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-30', 'size': 1248156, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-29T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single ascending dose'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2018-05-11', 'resultsFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2018-05-11', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-10', 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced At Least One Solicited Injection Site Adverse Event (AE)', 'timeFrame': 'Up to Day 5', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.'}, {'measure': 'Percentage of Participants Who Experienced At Least One Solicited Systemic Adverse Event (AE)', 'timeFrame': 'Up to Day 5', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs were monitored from Day 1 to Day 5.'}, {'measure': 'Percentage of Participants Who Experienced At Least One Serious Adverse Event (SAE)', 'timeFrame': 'Up to Day 545', 'description': 'An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum-Concentration Time Curve From Zero to Infinity (AUC0-∞)', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'AUC0-∞ is a measure of the extrapolated mean concentration in serum from dosing to infinity.'}, {'measure': 'Maximum Serum Concentration (Cmax) of Clesrovimab', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'Cmax is the highest observed serum drug concentration.'}, {'measure': 'Time to Maximum Serum Concentration (Tmax) of Clesrovimab', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 'Tmax is the time taken to reach the maximum observed plasma (Cmax) concentration of Clesrovimab.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Clesrovimab', 'timeFrame': 'At designated time points (up to 1 year post-dose)', 'description': 't1/2 is the time required for 50% of drug to be cleared from serum.'}, {'measure': 'Serum Concentration of Clesrovimab on Day 7 (C7days)', 'timeFrame': 'Day 7', 'description': 'Serum concentration of clesrovimab was measured on Day 7.'}, {'measure': 'Serum Concentration of Clesrovimab on Day 14 (C14days)', 'timeFrame': 'Day 14', 'description': 'Serum concentration of clesrovimab was measured on Day 14.'}, {'measure': 'Serum Concentration of Clesrovimab on Day 90 (C90days)', 'timeFrame': 'Day 90', 'description': 'Serum concentration of clesrovimab was measured on Day 90.'}, {'measure': 'Serum Concentration of Clesrovimab on Day 150 (C150days)', 'timeFrame': 'Day 150', 'description': 'Serum concentration of clesrovimab was measured on Day 150.'}, {'measure': 'Serum Concentration of Clesrovimab on Day 365 (C365days)', 'timeFrame': 'Day 365', 'description': 'Serum concentration of clesrovimab was measured on Day 365.'}, {'measure': 'Number of Participants With Positive Titer of Anti-Drug Antibodies (ADAs) for Clesrovimab: Panels A, B, C, D1, D2, E1, and E2', 'timeFrame': 'Days 14, 90, 150, 365 and 545', 'description': 'ADA was assessed at 2 or 3 of the following timepoints for each participant: Days 14, 90, 150, 365 and 545. ADA status for each participant was determined across the timepoints assessed. The definitions of the categories are as follows: (1) ADA Negative: participants whose ADA results were negative at all timepoints measured; (2) Non-treatment emergent positive: participants whose ADA result was positive only at baseline or if postdose titer increased by less than 2-fold relative to the baseline titer; (3) Positive response to MK-1654: participants whose ADA result was negative at baseline and positive at one or more postdose timepoints or participants whose ADA result was positive at baseline and postdose titer increased by greater than or equal to 2-fold relative to the baseline titer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Tract Infection', 'Respiratory Syncytial Virus']}, 'referencesModule': {'references': [{'pmid': '39601265', 'type': 'RESULT', 'citation': 'Madhi SA, Simoes EAF, Acevedo A, Novoa Pizarro JM, Shepard JS, Railkar RA, Cao X, Maas BM, Zang X, Krick A, Roadcap B, Vora KA, Aliprantis AO, Lee AW, Sinha A. A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants. J Infect Dis. 2025 Mar 17;231(3):e478-e487. doi: 10.1093/infdis/jiae581.'}, {'pmid': '39590882', 'type': 'RESULT', 'citation': 'Thambi N, Phuah JY, Staupe RP, Tobias LM, Cao Y, McKelvey T, Railkar RA, Aliprantis AO, Arriola CS, Maas BM, Vora KA. Development of High-Titer Antidrug Antibodies in a Phase 1b/2a Infant Clesrovimab Trial Are Associated With RSV Exposure Beyond Day 150. J Infect Dis. 2025 Mar 17;231(3):e488-e496. doi: 10.1093/infdis/jiae582.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at \\>35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.', 'detailedDescription': 'Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '2 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* is healthy, based on screening safety laboratory, medical history, and physical examination results\n* is a pre-term infant (born at 29 weeks to 35 weeks gestational age \\[inclusive\\]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records\n* weighs ≥2 kg at screening\n\nExclusion Criteria:\n\n* has been recommended to receive palivizumab per local standard of care\n* has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening\n* has a known hypersensitivity to any component of the respiratory syncytial virus (RSV) monoclonal antibody\n* has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)\n* has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive), or hepatitis C (HCV ribonucleic acid \\[RNA\\] positive)\n* has known history of functional or anatomic asplenia\n* has a diagnosis of failure to thrive within 14 days of screening\n* has known or history of a coagulation disorder contraindicating intramuscular injection\n* has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment\n* has prior known documented RSV infection\n* has hemodynamically significant congenital heart disease\n* has chronic lung disease of prematurity requiring ongoing medical therapy\n* has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study\n* has any history of malignancy prior to randomization\n* if any of the following apply, the Day 1 visit may be rescheduled for a time when these criteria are not met:\n* has had a recent febrile illness (rectal temperature 38.1°C \\[100.5°F\\] or higher or axillary temperature 37.8°C \\[100.0°F\\] or higher) within 72 hours pre-dose\n* is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening\n* has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose\n* has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus Calmette-Guerin vaccine) less than 30 days pre-dose\n* has received any prior vaccine or monoclonal antibody (mAb) for the prevention of RSV\n* is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study (participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor)\n* has enrolled previously in this study and been discontinued\n* participant's mother participated in a RSV vaccine clinical study while pregnant and participant is ≤3 months of chronological age\n* is unable to provide blood sample at screening\n* cannot be adequately followed for safety according to the protocol plan\n* has a parent/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study\n* is, or has, an immediate family member (eg, spouse, parent/guardian, sibling, or child) who is directly involved with the study at the site or with the Sponsor"}, 'identificationModule': {'nctId': 'NCT03524118', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants', 'orgStudyIdInfo': {'id': '1654-002'}, 'secondaryIdInfos': [{'id': 'MK-1654-002', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2017-005062-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: Pre-term clesrovimab Dose 1', 'description': 'Pre-term infants will receive clesrovimab Dose 1 via intramuscular (IM) injection and will be followed for up to 365 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: Pre-term clesrovimab Dose 2', 'description': 'Pre-term infants will receive clesrovimab Dose 2 via IM injection and will be followed for up to 365 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: Pre-term clesrovimab Dose 3', 'description': 'Pre-term infants will receive clesrovimab Dose 3 via IM injection and will be followed for up to 365 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D1: Pre-term clesrovimab Dose 4', 'description': 'Pre-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D2: Pre-term clesrovimab Dose 4', 'description': 'Pre-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E1: Full-term clesrovimab Dose 4', 'description': 'Full-term infants enrolled prior to AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 365 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E2: Full-term clesrovimab Dose 4', 'description': 'Full-term infants enrolled after AM4 will receive clesrovimab Dose 4 via IM injection and will be followed for up to 545 days.', 'interventionNames': ['Drug: Clesrovimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pre-term infants will receive placebo via IM injection.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clesrovimab', 'type': 'DRUG', 'otherNames': ['MK-1654'], 'description': 'Single ascending doses of clesrovimab will be administered via IM injection.', 'armGroupLabels': ['Panel A: Pre-term clesrovimab Dose 1', 'Panel B: Pre-term clesrovimab Dose 2', 'Panel C: Pre-term clesrovimab Dose 3', 'Panel D1: Pre-term clesrovimab Dose 4', 'Panel D2: Pre-term clesrovimab Dose 4', 'Panel E1: Full-term clesrovimab Dose 4', 'Panel E2: Full-term clesrovimab Dose 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (0.9% sodium chloride \\[NaCl\\]) will be administered via IM injection.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital - Colorado ( Site 0067)", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33030', 'city': 'Homestead', 'state': 'Florida', 'country': 'United States', 'facility': 'Next Phase Research Alliance, LLC ( Site 0075)', 'geoPoint': {'lat': 25.46872, 'lon': -80.47756}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Acevedo Clinical Research Associates ( Site 0025)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kapiolani Medical Center for Women and Children ( Site 0027)', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '66604', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081)", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital ( Site 0037)", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center ( Site 0032)', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University Hospital ( Site 0029)', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'WakeMed Health and Hospitals ( Site 0033)', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center ( Site 0031)", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association ( Site 0066)', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatric Research ( Site 0028)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Tribe Clinical Research, LLC ( Site 0082)', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch at Galveston ( Site 0039)', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Tekton Research, Inc. ( Site 0026)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Institute For Research And Innovation ( Site 0035)', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "University of Wisconsin American Family Children's Hospital ( Site 0068)", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '7650698', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Centro de Investigacion Clinica Bradford Hill ( Site 0103)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8242238', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Hospital La Florida ( Site 0050)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8380453', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Facultad Medicina Universidad de Chile ( Site 0104)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8880465', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Hospital Padre Hurtado ( Site 0102)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '050010', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Fundacion Hospital San Vicente de Paul ( Site 0097)', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '050036', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0098)', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '110221', 'city': 'Bogotá', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'MedPlus Medicina Prepagada S.A. ( Site 0095)', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '111411', 'city': 'Bogotá', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'Fundacion Universitaria de Ciencias de la Salud - Sociedad de Cirugia ( Site 0099)', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '250001', 'city': 'Chía', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0100)', 'geoPoint': {'lat': 4.85876, 'lon': -74.05866}}, {'zip': '760032', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Fundacion Valle del Lili ( Site 0090)', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '2013', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Academic Hospital ( Site 0262)', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '7505', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Tygerberg Hospital ( Site 0261)', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital ( Site 0071)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System ( Site 0073)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center ( Site 0072)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruna', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago ( Site 0241)', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz ( Site 0242)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}