Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-01-01 @ 11:33 AM
Study NCT ID:
NCT05281094
Status:
TERMINATED
Last Update Posted:
2025-07-10
First Post:
2022-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Two Doses of HIL-214 in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aborkowski@hillevax.com', 'phone': '+1 (617) 213-6562', 'title': 'Astrid Borkowski, Chief Medical Officer', 'organization': 'HilleVax, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine.', 'description': 'Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.', 'otherNumAtRisk': 1536, 'deathsNumAtRisk': 1536, 'otherNumAffected': 889, 'seriousNumAtRisk': 1536, 'deathsNumAffected': 1, 'seriousNumAffected': 165}, {'id': 'EG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.', 'otherNumAtRisk': 1541, 'deathsNumAtRisk': 1541, 'otherNumAffected': 902, 'seriousNumAtRisk': 1541, 'deathsNumAffected': 2, 'seriousNumAffected': 169}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 474}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 492}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 268}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 285}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 69}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 64}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebrovascular arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Polydactyly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sickle cell anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sudden infant death syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Metapneumovirus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia parainfluenzae viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Meningitis herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia adenoviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Exposure via ingestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Foreign body ingestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Burns third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Foreign body in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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[{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Accidental exposure to product by child', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chemical poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Post-procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory fume inhalation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholinergic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Patient device incompatibility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1536, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1541, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}, {'value': '1425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.\n\nPlacebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57.\n\nHIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'spread': '2.059', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.746', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.98', 'ciLowerLimit': '-52.51', 'ciUpperLimit': '50.35', 'estimateComment': '. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.', 'groupDescription': "VE is defined 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}, {'value': '1425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '1.886', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '1.519', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.02', 'ciLowerLimit': '-24.52', 'ciUpperLimit': '44.70', 'estimateComment': 'Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.', 'groupDescription': "VE is defined 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period, of moderate/severe AGE case associated with any (GI or GII) genogroup Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Samples that were positive for GI or GII genogroups were further analyzed for the presence of co-pathogens. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}, {'value': '1425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'spread': '1.981', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.628', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.91', 'ciLowerLimit': '-34.70', 'ciUpperLimit': '44.98', 'estimateComment': 'Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.', 'groupDescription': "VE is defined 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period\\* of moderate/severe AGE case associated with GI.1 or GII.4 norovirus genotypes, irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}, {'value': '1425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.19', 'spread': '1.852', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '1.541', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.37', 'ciLowerLimit': '-45.04', 'ciUpperLimit': '22.00', 'estimateComment': 'Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.', 'groupDescription': "VE is defined 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period of moderate/severe AGE case associated with any norovirus genogroup (GI or GII), irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of HIL-214 Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1538', 'groupId': 'OG000'}, {'value': '1540', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'title': 'Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1412', 'groupId': 'OG000'}, {'value': '1445', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.2'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '39.4'}]}]}, {'title': 'Anti-GI.1 HBGA-blocking seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.1'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '94.3', 'upperLimit': '96.6'}]}]}, {'title': 'Anti-GI.1 HBGA-blocking seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1371', 'groupId': 'OG000'}, {'value': '1391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.4'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '88.0'}]}]}, {'title': 'Anti-GII.4c HBGA-blocking seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1412', 'groupId': 'OG000'}, {'value': '1450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.1'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '8.9'}]}]}, {'title': 'Anti- GII.4c HBGA-blocking seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.2'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '45.6'}]}]}, {'title': 'Anti- GII.4c HBGA-blocking seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1371', 'groupId': 'OG000'}, {'value': '1399', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '7.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '27.4'}]}]}, {'title': 'Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1412', 'groupId': 'OG000'}, {'value': '1450', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.0'}]}]}, {'title': 'Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.7'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '44.9'}]}]}, {'title': 'Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1372', 'groupId': 'OG000'}, {'value': '1400', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '25.2'}]}]}, {'title': 'Anti-GI.1 pan-Ig seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}, {'value': '1447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '2.1'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '86.4'}]}]}, {'title': 'Anti-GI.1 pan-Ig seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.3'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.4'}]}]}, {'title': 'Anti-GI.1 pan-Ig seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1371', 'groupId': 'OG000'}, {'value': '1397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '10.3'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '97.9'}]}]}, {'title': 'Anti-GII.4c pan-Ig seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1410', 'groupId': 'OG000'}, {'value': '1448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '4.4'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '35.4', 'upperLimit': '40.5'}]}]}, {'title': 'Anti-GII.4c pan-Ig seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.7'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '81.9', 'upperLimit': '85.8'}]}]}, {'title': 'Anti-GII.4c pan-Ig seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1371', 'groupId': 'OG000'}, {'value': '1398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '26.0'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '73.1', 'upperLimit': '77.7'}]}]}, {'title': 'Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}, {'value': '1448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.7'}, {'value': '35.9', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '38.4'}]}]}, {'title': 'Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1390', 'groupId': 'OG000'}, {'value': '1416', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.7'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '85.4'}]}]}, {'title': 'Anti- GI.1 and GII.4c pan-Ig seroresponse rate at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1371', 'groupId': 'OG000'}, {'value': '1398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6.0'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '76.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participant reaches 1 year of age', 'description': 'The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at up to 56 days post dose 1 (Visit 2), 28 days post dose 2 (Visit 3), and/or at 1 year of age (visit 4) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-Analysis Set, The FAS will include all subjects who are randomized and received at least 1 dose of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1536', 'groupId': 'OG000'}, {'value': '1541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'title': 'Any solicited local AE', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days after each dose of HIL-214 or placebo.', 'description': 'Percentage of participants with solicited local (injection site) adverse events (AEs) within 7 days of vaccine administration. Assessed AEs include injection site pain, erythema, induration, and swelling.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants who were randomized and received at least 1 dose of trial vaccine (HIL-214 or placebo).'}, {'type': 'SECONDARY', 'title': 'Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1536', 'groupId': 'OG000'}, {'value': '1541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'title': 'Any solicited systemic AE', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '37.7', 'groupId': 'OG001'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Irritability/fussiness', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days after each dose of HIL-214 or placebo.', 'description': 'Percentage of participants with solicited systemic AEs within 7 days of vaccine administration. Assessed AEs include drowsiness, irritability/fussiness, loss of appetite, vomiting, and diarrhea.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, all participants that received at least 1 dose of HIL-214 or placebo.'}, {'type': 'SECONDARY', 'title': 'Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1536', 'groupId': 'OG000'}, {'value': '1541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after first dose of HIL-214 or placebo.', 'description': 'Percentage of participants with AEs leading to trial vaccine dose withdrawal.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set; all participants that received at least 1 dose of HIL 214 or placebo.'}, {'type': 'SECONDARY', 'title': 'Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1536', 'groupId': 'OG000'}, {'value': '1541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to end of the trial/early termination.', 'description': 'Percentage of participants with AEs leading to trial withdrawal.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set; all participants that received at least 1 dose of HIL-214 or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '6 month primary observation period, up to Visit 4', 'groupId': 'FG000', 'numSubjects': '1542'}, {'comment': '6 month primary observation period, up to Visit 4', 'groupId': 'FG001', 'numSubjects': '1542'}]}, {'type': 'Received Two Vaccinations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1399'}, {'groupId': 'FG001', 'numSubjects': '1425'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '6 month primary observation period, up to Visit 4', 'groupId': 'FG000', 'numSubjects': '1381'}, {'comment': '6 month primary observation period, up to Visit 4', 'groupId': 'FG001', 'numSubjects': '1410'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '132'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Legally Authorized Representative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not pre-specified reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants took part in the primary observation period of the trial (up to Visit 4) at 17 investigative sites in Panama, the Dominican Republic, Honduras, Peru, Columbia, Puerto Rico, and the United States from 28 April 2022 to 28 Dec 2023.', 'preAssignmentDetails': 'Participants were enrolled in 1 of 2 treatment arms and received 2 doses of either HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide, or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.94', 'spread': '0.295', 'groupId': 'BG000'}, {'value': '4.95', 'spread': '0.291', 'groupId': 'BG001'}, {'value': '4.95', 'spread': '0.293', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '723', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '1448', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '676', 'groupId': 'BG000'}, {'value': '700', 'groupId': 'BG001'}, {'value': '1376', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1383', 'groupId': 'BG000'}, {'value': '1407', 'groupId': 'BG001'}, {'value': '2790', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1302', 'groupId': 'BG000'}, {'value': '1327', 'groupId': 'BG001'}, {'value': '2629', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Puerto Rico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Panama', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '764', 'groupId': 'BG000'}, {'value': '769', 'groupId': 'BG001'}, {'value': '1533', 'groupId': 'BG002'}]}]}, {'title': 'Dominican Republic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}]}, {'title': 'Honduras', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}, {'value': '1425', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1397', 'groupId': 'BG000'}, {'value': '1422', 'groupId': 'BG001'}, {'value': '2819', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.423', 'spread': '0.9861', 'groupId': 'BG000'}, {'value': '7.395', 'spread': '0.9979', 'groupId': 'BG001'}, {'value': '7.409', 'spread': '0.9920', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Weight not reported for all participants.'}, {'title': 'Length', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1397', 'groupId': 'BG000'}, {'value': '1422', 'groupId': 'BG001'}, {'value': '2819', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.16', 'spread': '2.657', 'groupId': 'BG000'}, {'value': '64.05', 'spread': '2.731', 'groupId': 'BG001'}, {'value': '64.10', 'spread': '2.694', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Length not reported for all participants.'}, {'title': 'Head circumference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1395', 'groupId': 'BG000'}, {'value': '1419', 'groupId': 'BG001'}, {'value': '2814', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.08', 'spread': '1.316', 'groupId': 'BG000'}, {'value': '42.06', 'spread': '1.292', 'groupId': 'BG001'}, {'value': '42.07', 'spread': '1.304', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Head circumference not reported for all participants.'}], 'populationDescription': 'Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-01', 'size': 2499700, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-18T11:53', 'hasProtocol': True}, {'date': '2024-06-05', 'size': 10244347, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-18T11:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3084}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2022-02-17', 'resultsFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-08', 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes.', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported.'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup.', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period, of moderate/severe AGE case associated with any (GI or GII) genogroup Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Samples that were positive for GI or GII genogroups were further analyzed for the presence of co-pathogens. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported.'}, {'measure': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens.', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period\\* of moderate/severe AGE case associated with GI.1 or GII.4 norovirus genotypes, irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing.'}, {'measure': 'To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens', 'timeFrame': 'The duration of the primary observation period was 6 months starting at 28 days post dose 2.', 'description': 'Time to first occurrence during the primary observation period of moderate/severe AGE case associated with any norovirus genogroup (GI or GII), irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \\[1- (λV/λC)\\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported.'}, {'measure': 'Immunogenicity of HIL-214 Compared to Placebo', 'timeFrame': 'Participant reaches 1 year of age', 'description': 'The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at up to 56 days post dose 1 (Visit 2), 28 days post dose 2 (Visit 3), and/or at 1 year of age (visit 4) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses'}, {'measure': 'Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs)', 'timeFrame': 'Up to 7 days after each dose of HIL-214 or placebo.', 'description': 'Percentage of participants with solicited local (injection site) adverse events (AEs) within 7 days of vaccine administration. Assessed AEs include injection site pain, erythema, induration, and swelling.'}, {'measure': 'Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs)', 'timeFrame': 'Up to 7 days after each dose of HIL-214 or placebo.', 'description': 'Percentage of participants with solicited systemic AEs within 7 days of vaccine administration. Assessed AEs include drowsiness, irritability/fussiness, loss of appetite, vomiting, and diarrhea.'}, {'measure': 'Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal', 'timeFrame': 'Up to 28 days after first dose of HIL-214 or placebo.', 'description': 'Percentage of participants with AEs leading to trial vaccine dose withdrawal.'}, {'measure': 'Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal.', 'timeFrame': 'From Day 1 to end of the trial/early termination.', 'description': 'Percentage of participants with AEs leading to trial withdrawal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.', 'detailedDescription': 'Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include the very young, the elderly and immunocompromised individuals. Noroviruses are highly infectious, highly resistant to environmental conditions, and have multiple routes of transmission including person-to-person, food-borne and contaminated surfaces. Noroviruses can cause acute, mild to severe illness characterized by vomiting, diarrhea, fever, dehydration and abdominal pain, representing a significant burden to public health. The clinical presentation in adults and older children is similar. While mortality due to acute gastroenteritis (AGE) caused by norovirus in the pediatric population is rare in industrialized countries, it is more common in developing countries. Although potentially a cause for hospitalization in very young children, there are fewer cases during the first 6 months of life possibly due to the protection offered by maternal antibodies from trans-placental transfer and in breast milk. In addition, norovirus infections have significant socioeconomic impact on hospitals, schools, day care centers and other closed settings. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of AGE in many countries around the world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'minimumAge': '5 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* The subject should be 5 months of age (within plus or minus 14 days) male or female\n* Children who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator\n* The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements\n* Children whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up\n\nExclusion Criteria\n\n* Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines)\n* Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination\n* Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients)\n* Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (\\>100.4°F), within 3 days of intended trial vaccination\n* Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease)\n* Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial\n* Known or suspected impairment/alteration of immune function\n* Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time\n* Subjects who received or are scheduled to receive any other vaccines within 14 days (for inactivated vaccines and oral polio vaccine) or 28 days (for other live vaccines) before or after any dose of trial vaccine\n* Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial\n* Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection\n* Subject's LAR or subject's first-degree relatives involved in the trial conduct"}, 'identificationModule': {'nctId': 'NCT05281094', 'briefTitle': 'Efficacy and Safety of Two Doses of HIL-214 in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'HilleVax'}, 'officialTitle': 'A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination', 'orgStudyIdInfo': {'id': 'NOR-212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.', 'interventionNames': ['Biological: HIL-214']}], 'interventions': [{'name': 'HIL-214', 'type': 'BIOLOGICAL', 'description': '2 injections - given on Day 1 and the second given between Day 29 - Day 57', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '2 injections - given on Day 1 and the second given between Day 29 - Day 57', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77065', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'DM Clinical Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Bogotá', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'Policlinico Social del Norte', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '760042', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Cntro de Estudios en Infectologia Pediatrica (CEIP)', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Santo Domingo', 'state': 'Nacional', 'country': 'Dominican Republic', 'facility': 'Hospital Pediátrico Dr. Hugo Mendoza', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'zip': '11102', 'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Hospital General Regional Marcelino Velez Santana', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'CAIMED - Dominican Center for Clinical Studies', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Clínica Cruz Jiminian', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Fundacion Dominicana de Perinatologia Pro Bebe', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Demedica', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}, {'city': 'Tegucigalpa', 'country': 'Honduras', 'facility': 'INVERIME - Inversiones en Investigación Medica', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}, {'city': 'Tegucigalpa', 'country': 'Honduras', 'facility': 'Investigación Sin Limite', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}, {'zip': '00507', 'city': 'David', 'state': 'Chiriquí Province', 'country': 'Panama', 'facility': 'CEVAXIN David', 'geoPoint': {'lat': 8.42729, 'lon': -82.43085}}, {'city': 'La Chorrera', 'country': 'Panama', 'facility': 'CEVAXIN La Chorrera', 'geoPoint': {'lat': 8.87763, 'lon': -79.78007}}, {'zip': '00831', 'city': 'Panama City', 'country': 'Panama', 'facility': 'CEVAXIN 24 Decembre', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'CEVAXIN Av. México', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '15024', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto de Investigacion Nutricional', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Guayama', 'country': 'Puerto Rico', 'facility': 'Clinical Research Puerto Rico', 'geoPoint': {'lat': 17.98413, 'lon': -66.11378}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HilleVax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}