Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-01 @ 4:59 PM
Study NCT ID:
NCT05033561
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rruttimann@fidec-online.org', 'phone': '+5491161188536', 'title': 'Ricardo Rüttimann', 'organization': 'FIDEC Corporation'}, 'certainAgreement': {'otherDetails': 'The PI and/or the Institution are not entitled to publish or present any study information, either partial or complete, without written approval by FIDEC.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Assessments were performed on the Total Vaccinated Population (TVP). Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 217, 'seriousNumAtRisk': 298, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart', 'otherNumAtRisk': 304, 'deathsNumAtRisk': 304, 'otherNumAffected': 247, 'seriousNumAtRisk': 304, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 238, 'seriousNumAtRisk': 303, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abnormal crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 102, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 144, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 123, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 59, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 80, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 64, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 49, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 153, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 182, 'numAffected': 152}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 164, 'numAffected': 144}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 65, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 55, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Loss of apetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 42, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 53, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 65, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 118, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 97, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Amoebic Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Viral Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Seborrheic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Hereditary haemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Hereditary spherocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 303, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroconversion Rate at 1, 2 & 4 Weeks Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'This is the nominal alpha level for the two-sided confidence interval comparison.', 'groupDescription': 'This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.', 'nonInferiorityComment': 'Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.'}, {'pValue': '0.05', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'This is the nominal alpha level for the two-sided confidence interval comparison.', 'groupDescription': 'This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.', 'nonInferiorityComment': 'Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to max 8 weeks', 'description': 'Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Neutralizing Antibodies at 1, 2 & 4 Week Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '13.5'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '14.7'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '12.9'}]}]}, {'title': '28 days after 2nd dose', 'categories': [{'measurements': [{'value': '1232.3', 'groupId': 'OG000', 'lowerLimit': '909', 'upperLimit': '1670.5'}, {'value': '1726.3', 'groupId': 'OG001', 'lowerLimit': '1252.1', 'upperLimit': '2380.1'}, {'value': '2327.6', 'groupId': 'OG002', 'lowerLimit': '1654.3', 'upperLimit': '3275.2'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'This is the nominal alpha level for the two-sided confidence interval comparison.', 'groupDescription': 'This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.', 'nonInferiorityComment': 'Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.'}, {'pValue': '0.05', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'This is the nominal alpha level for the two-sided confidence interval comparison.', 'groupDescription': 'This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).', 'statisticalMethod': 'Miettinen-Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.', 'nonInferiorityComment': 'Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to max 8 weeks', 'description': 'Geometric mean titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1, 2 \\& 4 weeks apart.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events (SAEs) and Important Medical Events (IMEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Birth defect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of participants experiencing SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total Vaccinated Population. Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.'}, {'type': 'SECONDARY', 'title': 'Solicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}], 'classes': [{'title': 'Abnormal crying', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Apetite', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to max 5 weeks', 'description': 'Number of participants experiencing mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total Vaccinated Population. Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan. Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.'}, {'type': 'SECONDARY', 'title': 'Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}], 'classes': [{'title': 'Respiratory disorders', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Infections', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Skin disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Congenital disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'General disorders', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to max 8 weeks', 'description': 'Number of participants experiencing mild, moderate, and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea, and irritability) for 28 days after each dose of study vaccine in all groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total Vaccinated Population. Please note that for the safety analysis, subjects were classified according to the actual administration interval received per the Statistical Analysis Plan (SAP). Thus, 4 patients randomized into Group A were assigned to Group B for safety analysis tables.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart\n\nnOPV2: Novel Oral Poliomyelitis Type 2 Vaccine'}, {'id': 'FG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart\n\nnOPV2: Novel Oral Poliomyelitis Type 2 Vaccine'}, {'id': 'FG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart\n\nnOPV2: Novel Oral Poliomyelitis Type 2 Vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '297'}, {'groupId': 'FG002', 'numSubjects': '298'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '905', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Administration of 2 doses of nOPV2, 1 week apart'}, {'id': 'BG001', 'title': 'Group B', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart'}, {'id': 'BG002', 'title': 'Group C', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '905', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '418', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '487', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}, {'value': '901', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Dominican Republic', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}, {'value': '905', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-14', 'size': 679907, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-19T11:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 905}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2021-08-19', 'resultsFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-01', 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion Rate at 1, 2 & 4 Weeks Interval', 'timeFrame': 'Up to max 8 weeks', 'description': 'Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age'}], 'secondaryOutcomes': [{'measure': 'Neutralizing Antibodies at 1, 2 & 4 Week Interval', 'timeFrame': 'Up to max 8 weeks', 'description': 'Geometric mean titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1, 2 \\& 4 weeks apart.'}, {'measure': 'Serious Adverse Events (SAEs) and Important Medical Events (IMEs)', 'timeFrame': '6 months', 'description': 'Number of participants experiencing SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.'}, {'measure': 'Solicited Adverse Events (AEs)', 'timeFrame': 'Up to max 5 weeks', 'description': 'Number of participants experiencing mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.'}, {'measure': 'Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to max 8 weeks', 'description': 'Number of participants experiencing mild, moderate, and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea, and irritability) for 28 days after each dose of study vaccine in all groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Poliomyelitis']}, 'referencesModule': {'references': [{'pmid': '38109921', 'type': 'DERIVED', 'citation': 'Rivera Mejia L, Pena Mendez L, Bandyopadhyay AS, Gast C, Mazara S, Rodriguez K, Rosario N, Zhang Y, Mainou BA, Jimeno J, Aguirre G, Ruttimann R. Safety and immunogenicity of shorter interval schedules of the novel oral poliovirus vaccine type 2 in infants: a phase 3, randomised, controlled, non-inferiority study in the Dominican Republic. Lancet Infect Dis. 2024 Mar;24(3):275-284. doi: 10.1016/S1473-3099(23)00519-4. Epub 2023 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants', 'detailedDescription': "This will be a multicenter, randomized, controlled, open-label, parallel-group Phase III study in healthy infants aged 6 to 8 weeks who have never been vaccinated against poliomyelitis. Approximately 900 infants will be included in the study and randomized with a 1:1:1 ratio to the following treatment groups:\n\n* Group A: approximately 300 subjects to receive 2 doses of nOPV2 administered 1 week apart, at Day 0 and Day 7;\n* Group B: approximately 300 subjects to receive 2 doses of nOPV2 administered 2 weeks apart, at Day 0 and Day 14;\n* Group C (control group): approximately 300 subjects to receive 2 doses of nOPV2 administered 4 weeks apart, at Day 0 and Day 28. A total of 4 on-site visits are planned. Approximately 7 days after each administration of study vaccine, a phone call or on-site visit will be performed to monitor subjects' safety and review with the subject's parent(s)/guardian(s) any solicited AEs reported in the electronic diary card. All subjects will have a safety follow-up phone call 6 months after the last dose of study vaccine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infants aged 6 to 8 weeks with birth weight \\> 2,500 g.\n2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.\n3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.\n\nExclusion Criteria:\n\n1. Infants who have received previous vaccination against poliomyelitis.\n2. Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP).\n3. Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.\n4. Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration.\n5. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject\'s household.\n6. Family history of congenital or hereditary immunodeficiency.\n7. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).\n8. Known allergy to any component of the study vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine.\n9. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.\n10. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).\n11. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.\n12. Infants from multiple births or born prematurely (\\< 37 weeks of gestation)'}, 'identificationModule': {'nctId': 'NCT05033561', 'briefTitle': 'Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Fidec Corporation'}, 'officialTitle': 'A Phase III Open-label Randomized Controlled Study to Evaluate the Safety and Immunogenicity of nOPV2 at Different Intervals of Administration in Infants', 'orgStudyIdInfo': {'id': 'nOPV2-002-ABMG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 doses, 1 week apart', 'description': 'Administration of 2 doses of nOPV2, 1 week apart', 'interventionNames': ['Biological: nOPV2']}, {'type': 'EXPERIMENTAL', 'label': '2 doses, 2 week apart', 'description': 'Administration of 2 doses of nOPV2, 2 weeks apart', 'interventionNames': ['Biological: nOPV2']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 doses, 4 week apart', 'description': 'Administration of 2 doses of nOPV2, 4 weeks apart', 'interventionNames': ['Biological: nOPV2']}], 'interventions': [{'name': 'nOPV2', 'type': 'BIOLOGICAL', 'description': 'Novel Oral Poliomyelitis Type 2 Vaccine', 'armGroupLabels': ['2 doses, 1 week apart', '2 doses, 2 week apart', '2 doses, 4 week apart']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Clinica Cruz Jiminián', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Hospital Universitario Maternidad Nuestra Señora de la Altagracia', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fidec Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}