Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03869333
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004405', 'term': 'Dysentery, Bacillary'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004403', 'term': 'Dysentery'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rerdem@path.org', 'phone': '+1 202 540 4546', 'title': 'Rahsan Erdem', 'organization': 'PATH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to 28 days following the third immunization (71 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Appetite disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '76.84', 'upperLimit': '100.00'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '79.41', 'upperLimit': '100.00'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '79.41', 'upperLimit': '100.00'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '61.52', 'upperLimit': '99.79'}]}]}, {'title': 'Any Grade 2 or greater AE', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '23.04', 'upperLimit': '76.96'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '29.88', 'upperLimit': '80.25'}, {'value': '43.8', 'groupId': 'OG002', 'lowerLimit': '19.75', 'upperLimit': '70.12'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '5.49', 'upperLimit': '57.19'}]}]}, {'title': 'Any AE related to study drug', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '76.84', 'upperLimit': '100.00'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '79.41', 'upperLimit': '100.00'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '79.41', 'upperLimit': '100.00'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '27.67', 'upperLimit': '84.83'}]}]}, {'title': 'Any Grade 2 or greater AE related to study drug', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '42.81'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '19.75', 'upperLimit': '70.12'}, {'value': '31.3', 'groupId': 'OG002', 'lowerLimit': '11.02', 'upperLimit': '58.66'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '0.21', 'upperLimit': '38.48'}]}]}, {'title': 'Any serious adverse event (SAE)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '23.16'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '20.59'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '20.59'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '26.46'}]}]}, {'title': 'Any SAE related to study drug', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '23.16'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '20.59'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '20.59'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '26.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 28 days following the third immunization (71 days)', 'description': 'All adverse events (AEs) were assessed for severity by the investigator according to the following scale:\n\nGrade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort;\n\nGrade 2 (Moderate): Interferes with routine activities, moderate level of discomfort;\n\nGrade 3 (Severe): Unable to perform routine activities, significant level of discomfort;\n\nGrade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event.\n\nAn AE was considered "serious" if it resulted in any of the following outcomes:\n\n* Death\n* Life-threatening AE\n* Inpatient hospitalization or prolongation of existing hospitalization\n* Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions\n* Congenital anomaly/birth defect.\n\nThe Investigator assessed the relationship of each adverse event to study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least one immunization (Invaplex\\[AR-Detox\\] or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Any Solicited AE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Appetite disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site erythema', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site induration', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after the first immunization (Days 1 to 7)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the first dose (Invaplex\\[AR-Detox\\] or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Any Solicited AE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Appetite disorder', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site erythema', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site induration', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after the second immunization (Days 22 to 28)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the second dose (Invaplex\\[AR-Detox\\] or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Adverse Events After Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Any Solicited AE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Appetite disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site erythema', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site induration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site pruritus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vaccination site swelling', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after the third immunization (Days 43 to 49)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the third dose (Invaplex\\[AR-Detox\\] or placebo).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Events After Each Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Unsolicited adverse events after first dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Unsolicited adverse events after second dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Unsolicited adverse events after third dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received each dose (Invaplex\\[AR-Detox\\] or placebo).'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '189.6', 'groupId': 'OG000', 'lowerLimit': '101.3', 'upperLimit': '355.1'}, {'value': '126.0', 'comment': 'Less than the lower limit of quantitation', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '206.8'}, {'value': '141.4', 'comment': 'Less than the lower limit of quantitation', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': '246.6'}, {'value': '200.0', 'groupId': 'OG003', 'lowerLimit': '117.6', 'upperLimit': '340.2'}]}]}, {'title': 'Day 22 (pre-dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3560.1', 'groupId': 'OG000', 'lowerLimit': '1077.5', 'upperLimit': '11762.5'}, {'value': '2917.5', 'groupId': 'OG001', 'lowerLimit': '1607.8', 'upperLimit': '5294.0'}, {'value': '14576.5', 'groupId': 'OG002', 'lowerLimit': '7212.2', 'upperLimit': '29460.2'}, {'value': '188.8', 'groupId': 'OG003', 'lowerLimit': '127.0', 'upperLimit': '280.6'}]}]}, {'title': 'Day 43 (pre-dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3375.3', 'groupId': 'OG000', 'lowerLimit': '955.5', 'upperLimit': '11922.4'}, {'value': '2425.1', 'groupId': 'OG001', 'lowerLimit': '1443.2', 'upperLimit': '4075.3'}, {'value': '9451.7', 'groupId': 'OG002', 'lowerLimit': '4631.8', 'upperLimit': '19287.4'}, {'value': '165.6', 'comment': 'Less than the lower limit of quantitation', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '276.8'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3200.0', 'groupId': 'OG000', 'lowerLimit': '975.8', 'upperLimit': '10494.3'}, {'value': '2785.8', 'groupId': 'OG001', 'lowerLimit': '1612.5', 'upperLimit': '4812.6'}, {'value': '11033.3', 'groupId': 'OG002', 'lowerLimit': '5649.8', 'upperLimit': '21546.2'}, {'value': '149.8', 'comment': 'Less than the lower limit of quantitation', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': '241.5'}]}]}, {'title': 'Day 57 (14 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4271.5', 'groupId': 'OG000', 'lowerLimit': '1293.7', 'upperLimit': '14103.6'}, {'value': '3200.0', 'groupId': 'OG001', 'lowerLimit': '1729.1', 'upperLimit': '5922.1'}, {'value': '10307.1', 'groupId': 'OG002', 'lowerLimit': '5419.5', 'upperLimit': '19602.9'}, {'value': '178.2', 'groupId': 'OG003', 'lowerLimit': '109.1', 'upperLimit': '291.1'}]}]}, {'title': 'Day 71 (28 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4031.7', 'groupId': 'OG000', 'lowerLimit': '1063.9', 'upperLimit': '15279.1'}, {'value': '2211.1', 'groupId': 'OG001', 'lowerLimit': '1158.1', 'upperLimit': '4221.3'}, {'value': '9451.7', 'groupId': 'OG002', 'lowerLimit': '4883.7', 'upperLimit': '18292.3'}, {'value': '211.9', 'groupId': 'OG003', 'lowerLimit': '126.9', 'upperLimit': '353.9'}]}]}], 'analyses': [{'pValue': '0.504', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.058', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1516.9', 'groupId': 'OG000', 'lowerLimit': '850.2', 'upperLimit': '2706.4'}, {'value': '1269.9', 'groupId': 'OG001', 'lowerLimit': '592.0', 'upperLimit': '2723.9'}, {'value': '2166.8', 'groupId': 'OG002', 'lowerLimit': '1308.9', 'upperLimit': '3587.0'}, {'value': '1695.1', 'groupId': 'OG003', 'lowerLimit': '830.0', 'upperLimit': '3461.9'}]}]}, {'title': 'Day 22 (pre-dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15020.3', 'groupId': 'OG000', 'lowerLimit': '4474.5', 'upperLimit': '50421.6'}, {'value': '22286.1', 'groupId': 'OG001', 'lowerLimit': '11426.7', 'upperLimit': '43465.7'}, {'value': '75613.5', 'groupId': 'OG002', 'lowerLimit': '41386.6', 'upperLimit': '138146.2'}, {'value': '1795.9', 'groupId': 'OG003', 'lowerLimit': '916.5', 'upperLimit': '3519.3'}]}]}, {'title': 'Day 43 (pre-dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25600.0', 'groupId': 'OG000', 'lowerLimit': '8027.0', 'upperLimit': '81644.6'}, {'value': '29406.7', 'groupId': 'OG001', 'lowerLimit': '15572.4', 'upperLimit': '55531.0'}, {'value': '106933.6', 'groupId': 'OG002', 'lowerLimit': '65186.0', 'upperLimit': '175418.1'}, {'value': '1704.1', 'groupId': 'OG003', 'lowerLimit': '696.6', 'upperLimit': '4168.8'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27122.3', 'groupId': 'OG000', 'lowerLimit': '8727.4', 'upperLimit': '84288.0'}, {'value': '37050.1', 'groupId': 'OG001', 'lowerLimit': '20418.3', 'upperLimit': '67229.4'}, {'value': '113058.8', 'groupId': 'OG002', 'lowerLimit': '70861.9', 'upperLimit': '180383.0'}, {'value': '1795.9', 'groupId': 'OG003', 'lowerLimit': '996.7', 'upperLimit': '3236.2'}]}]}, {'title': 'Day 57 (14 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34171.9', 'groupId': 'OG000', 'lowerLimit': '11722.7', 'upperLimit': '99611.8'}, {'value': '44572.2', 'groupId': 'OG001', 'lowerLimit': '22853.4', 'upperLimit': '86931.5'}, {'value': '116612.0', 'groupId': 'OG002', 'lowerLimit': '79218.2', 'upperLimit': '171656.8'}, {'value': '2015.9', 'groupId': 'OG003', 'lowerLimit': '1135.8', 'upperLimit': '3577.8'}]}]}, {'title': 'Day 71 (28 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36203.9', 'groupId': 'OG000', 'lowerLimit': '13769.6', 'upperLimit': '95189.5'}, {'value': '42559.4', 'groupId': 'OG001', 'lowerLimit': '23621.8', 'upperLimit': '76679.4'}, {'value': '106933.6', 'groupId': 'OG002', 'lowerLimit': '65186.0', 'upperLimit': '175418.1'}, {'value': '1425.4', 'groupId': 'OG003', 'lowerLimit': '747.1', 'upperLimit': '2719.6'}]}]}], 'analyses': [{'pValue': '0.129', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.2'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '1.0', 'comment': 'Confidence interval could not be calculated as there was no variation among participants in this arm.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 8 (7 days after dose 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '139.6', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '539.9'}, {'value': '115.2', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '614.4'}, {'value': '275.5', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '1222.3'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.6'}]}]}, {'title': 'Day 29 (7 days after dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '64.7'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '30.7'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '20.6'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '13.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '8.7'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '9.0'}, {'value': '0.0', 'comment': 'Confidence interval could not be calculated as there was no variation among participants in this arm.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.601', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.628', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.878', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.6'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.3'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '2.5'}]}]}, {'title': 'Day 8 (7 days after dose 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '310.6', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '1259.2'}, {'value': '220.1', 'groupId': 'OG001', 'lowerLimit': '38.3', 'upperLimit': '1266.3'}, {'value': '806.7', 'groupId': 'OG002', 'lowerLimit': '192.9', 'upperLimit': '3373.5'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '2.6'}]}]}, {'title': 'Day 29 (7 days after dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '78.3'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '217.0'}, {'value': '80.8', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '205.0'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '38.2'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '246.5'}, {'value': '65.4', 'groupId': 'OG002', 'lowerLimit': '17.8', 'upperLimit': '240.2'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}], 'analyses': [{'pValue': '0.762', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline', 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'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '51.59', 'upperLimit': '97.91'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '59.54', 'upperLimit': '98.34'}, {'value': '92.9', 'groupId': 'OG002', 'lowerLimit': '66.13', 'upperLimit': '99.82'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '26.46'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': "Fisher's exact 2-tail tests of differences between the 3 Invaplex\\[AR-Detox\\] dose groups in seroconversion rates at Day 8", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.412', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': "Fisher's exact 2-tail tests of differences between the 3 Invaplex\\[AR-Detox\\] dose 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[{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Day 22 (pre-dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '48.0'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '51.2'}, {'value': '103.1', 'groupId': 'OG002', 'lowerLimit': '46.0', 'upperLimit': '230.8'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.2'}]}]}, {'title': 'Day 43 (pre-dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '43.2'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '40.0'}, {'value': '66.8', 'groupId': 'OG002', 'lowerLimit': '30.3', 'upperLimit': '147.5'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '1.1'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '33.9'}, {'value': '22.1', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '44.2'}, {'value': '74.2', 'groupId': 'OG002', 'lowerLimit': '34.3', 'upperLimit': '160.7'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '0.9'}]}]}, {'title': 'Day 57 (14 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '52.0'}, {'value': '25.4', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '54.5'}, {'value': '72.9', 'groupId': 'OG002', 'lowerLimit': '34.3', 'upperLimit': '154.8'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.1'}]}]}, {'title': 'Day 71 (28 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '49.9'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '39.3'}, {'value': '66.8', 'groupId': 'OG002', 'lowerLimit': '30.3', 'upperLimit': '147.5'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.037', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.', 'unitOfMeasure': 'fold-rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-rise in Serum IgG From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Day 22 (pre-dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '25.8'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '28.3'}, {'value': '34.9', 'groupId': 'OG002', 'lowerLimit': '20.4', 'upperLimit': '59.7'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.4'}]}]}, {'title': 'Day 43 (pre-dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '42.0'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '45.6'}, {'value': '49.4', 'groupId': 'OG002', 'lowerLimit': '27.5', 'upperLimit': '88.7'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '1.4'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '41.3'}, {'value': '29.2', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '52.0'}, {'value': '45.3', 'groupId': 'OG002', 'lowerLimit': '23.8', 'upperLimit': '86.0'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.4'}]}]}, {'title': 'Day 57 (14 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '46.8'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '65.9'}, {'value': '53.8', 'groupId': 'OG002', 'lowerLimit': '30.6', 'upperLimit': '94.6'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '1.7'}]}]}, {'title': 'Day 71 (28 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '46.3'}, {'value': '33.5', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '66.7'}, {'value': '49.4', 'groupId': 'OG002', 'lowerLimit': '27.1', 'upperLimit': '90.0'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '1.2'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.146', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.126', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.273', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.', 'unitOfMeasure': 'fold-rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-rise in ALS IgA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Day 8 (7 days after dose 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '132.3', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '489.4'}, {'value': '87.3', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '410.2'}, {'value': '241.9', 'groupId': 'OG002', 'lowerLimit': '53.4', 'upperLimit': '1095.1'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.6'}]}]}, {'title': 'Day 29 (7 days after dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '63.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '20.5'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '18.0'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '1.2'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '12.8'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.0'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '8.0'}, {'value': '1.0', 'comment': 'Confidence interval could not be calculated as there was no variation among participants in this arm at this time point.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50', 'unitOfMeasure': 'fold-rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold-rise in ALS IgG From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'classes': [{'title': 'Day 8 (7 days after dose 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '250.9', 'groupId': 'OG000', 'lowerLimit': '62.0', 'upperLimit': '1015.4'}, {'value': '200.7', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '1103.6'}, {'value': '708.3', 'groupId': 'OG002', 'lowerLimit': '163.3', 'upperLimit': '3072.4'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '2.2'}]}]}, {'title': 'Day 29 (7 days after dose 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '64.7'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '190.1'}, {'value': '70.3', 'groupId': 'OG002', 'lowerLimit': '28.2', 'upperLimit': '175.6'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '1.5'}]}]}, {'title': 'Day 50 (7 days after dose 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '33.2'}, {'value': '64.9', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '220.1'}, {'value': '59.2', 'groupId': 'OG002', 'lowerLimit': '15.7', 'upperLimit': '223.6'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '1.3'}]}]}], 'analyses': [{'pValue': '0.348', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50', 'unitOfMeasure': 'fold-rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'FG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'FG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Received First Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Received Second Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Received Third Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'comment': 'Completed Day 71 visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, MD, USA. Healthy adults were recruited from the Baltimore/Washington, DC area.', 'preAssignmentDetails': 'In this dose-escalation study participants were assigned to receive 3 vaccinations of 1 of 3 doses of detoxified Shigella flexneri 2a artificial invasin complex (Invaplex\\[AR-Detox\\]) or placebo. The study was initiated with the lowest dose level (2.5 μg) and proceeded to the next highest dose in an escalating fashion after review of safety data by the Protocol Safety Review Team.\n\nWithin each dose cohort participants were randomly assigned to receive Invaplex\\[AR-Detox\\] or placebo in a 4: 1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'BG001', 'title': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'BG002', 'title': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '28.9', 'spread': '6.0', 'groupId': 'BG003'}, {'value': '32.5', 'spread': '7.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled and randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 1179602, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-06T16:08', 'hasProtocol': True}, {'date': '2020-08-18', 'size': 6840154, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-07T13:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2019-03-04', 'resultsFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-07', 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'From first dose up to 28 days following the third immunization (71 days)', 'description': 'All adverse events (AEs) were assessed for severity by the investigator according to the following scale:\n\nGrade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort;\n\nGrade 2 (Moderate): Interferes with routine activities, moderate level of discomfort;\n\nGrade 3 (Severe): Unable to perform routine activities, significant level of discomfort;\n\nGrade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event.\n\nAn AE was considered "serious" if it resulted in any of the following outcomes:\n\n* Death\n* Life-threatening AE\n* Inpatient hospitalization or prolongation of existing hospitalization\n* Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions\n* Congenital anomaly/birth defect.\n\nThe Investigator assessed the relationship of each adverse event to study drug.'}, {'measure': 'Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1', 'timeFrame': '7 days after the first immunization (Days 1 to 7)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise'}, {'measure': 'Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2', 'timeFrame': '7 days after the second immunization (Days 22 to 28)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise'}, {'measure': 'Number of Participants With Solicited Adverse Events After Dose 3', 'timeFrame': '7 days after the third immunization (Days 43 to 49)', 'description': 'The solicited AEs for this study included:\n\n* Site pain\n* Site tenderness\n* Swelling\n* Induration (determined by investigator exam)\n* Site redness\n* Pruritus\n* Fever\n* Nausea\n* Vomiting\n* Abdominal pain\n* Diarrhea (loose stools)\n* Appetite change\n* Fatigue\n* Headache\n* Myalgias (general pain or soreness in muscles)\n* Arthralgias (general pain in joints)\n* Malaise'}, {'measure': 'Number of Participants With Unsolicited Adverse Events After Each Dose', 'timeFrame': 'Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.'}, {'measure': 'Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.'}, {'measure': 'Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS)', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50'}, {'measure': 'Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50'}, {'measure': 'Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline', 'timeFrame': 'Days 1 (Baseline), 22 43, 50, 57 and 71', 'description': 'Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.'}, {'measure': 'Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline', 'timeFrame': 'Days 1 (Baseline), 22 43, 50, 57 and 71', 'description': 'Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.'}, {'measure': 'Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50', 'description': 'Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.'}, {'measure': 'Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50', 'description': 'Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline.'}, {'measure': 'Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.'}, {'measure': 'Geometric Mean Fold-rise in Serum IgG From Baseline', 'timeFrame': 'Days 1 (Baseline), 22, 43, 50, 57 and 71.'}, {'measure': 'Geometric Mean Fold-rise in ALS IgA From Baseline', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50'}, {'measure': 'Geometric Mean Fold-rise in ALS IgG From Baseline', 'timeFrame': 'Days 1 (Baseline), 8, 29, and 50'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shigella flexneri 2a', 'Enteric', 'Shigella'], 'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex\\[AR-Detox\\]) vaccine candidate administered by intramuscular immunization.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex\\[AR-DETOX\\] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation.\n\nSpecimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, adult, male or female, age 18 to 50 years (inclusive) at the time of enrollment.\n* Completion and review of comprehension test (achieved ≥ 70% accuracy, two attempts allowed).\n* Provide written informed consent before initiation of any study procedures.\n* Agrees to complete all study visits and procedures and to provide a screening stool sample.\n* Women of childbearing capacity: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following the last vaccine dose.\n\nExclusion Criteria:\n\n* Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other conditions that might place the subjects at increased risk of adverse events) - study clinicians, in consultation with the Principal Investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.\n* History of autoimmune disorders, cardiovascular and renal disease.\n* Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including immunoglobulin A (IgA) deficiency (defined by serum IgA \\< 7 mg/dL).\n* Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women.\n* Participation in research involving another investigational product (defined as receipt of an investigational product or exposure to an invasive investigational device) 30 days before planned date of first vaccination or anytime throughout the duration of the study until the last in-clinic study safety visit.\n* Positive blood test for hepatitis B surface antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV)-1/HIV-2 antibody.\n* Clinically significant abnormalities on basic laboratory screening tests.\n* Systemic antimicrobial treatment (i.e., topical treatments are not an exclusion) within 1 week before administration of the first vaccine dose.\n* Allergies that may increase the risk of adverse events (AEs).\n* Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy.\n* Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.\n* Personal or family history of an inflammatory arthritis.\n* Positive blood test for human leukocyte antigen (HLA) B27 (associated with increased risk of reactive arthritis secondary to Shigella infection)\n* History of allergy to any vaccine.\n* Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of a local AE.\n* Serum immunoglobulin G (IgG) titer \\> 2500 to Shigella flexneri 2a lipopolysaccharide antigen (LPS).\n* History of microbiologically confirmed Shigella infection.\n* Received previous licensed or experimental Shigella vaccine or live Shigella challenge.\n* Travel to countries where Shigella or other enteric infections are endemic (most of the developing world) within two years prior to dosing (clinician judgement).\n* Occupation involving handling of Shigella bacteria currently, or in the past 3 years.'}, 'identificationModule': {'nctId': 'NCT03869333', 'briefTitle': 'Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]', 'organization': {'class': 'OTHER', 'fullName': 'PATH'}, 'officialTitle': 'A Phase 1 Double-blind, Placebo-controlled, Dose Escalating Study of Intramuscular Detoxified Shigella Flexneri 2a Artificial Invasin Complex (Invaplex[AR-DETOX]) Vaccine', 'orgStudyIdInfo': {'id': 'CVIA 064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invaplex[AR-Detox] 2.5 μg', 'description': 'Participants received an intramuscular injection of 2.5 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'interventionNames': ['Biological: Invaplex[AR-DETOX]']}, {'type': 'EXPERIMENTAL', 'label': 'Invaplex[AR-Detox] 10 μg', 'description': 'Participants received an intramuscular injection of 10 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'interventionNames': ['Biological: Invaplex[AR-DETOX]']}, {'type': 'EXPERIMENTAL', 'label': 'Invaplex[AR-Detox] 25 μg', 'description': 'Participants received an intramuscular injection of 25 μg Invaplex\\[AR-DETOX\\] vaccine on Days 1, 22, and 43.', 'interventionNames': ['Biological: Invaplex[AR-DETOX]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Invaplex[AR-DETOX]', 'type': 'BIOLOGICAL', 'description': 'Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex\\[AR-Detox\\]) Vaccine', 'armGroupLabels': ['Invaplex[AR-Detox] 10 μg', 'Invaplex[AR-Detox] 2.5 μg', 'Invaplex[AR-Detox] 25 μg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed Army Institute of Research Clinical Trials Center (WRAIR CTC)', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}], 'overallOfficials': [{'name': 'Ramiro Gutierrez, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Naval Medical Research Center (NMRC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PATH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}