Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-03-13 @ 4:25 AM
Study NCT ID:
NCT02545868
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2015-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C533411', 'term': 'ocrelizumab'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up 5 years, 10 months, 26 days', 'description': 'Group A received 600 mg OCR and then vaccine challenge Group B received no OCR, just vaccine challenge.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A1', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 31, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 34, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. No study drug was administered.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 32, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OCULAR HYPERAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ANAL INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GAIT DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INJECTION SITE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PERIPHERAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'TEMPERATURE INTOLERANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SEASONAL ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'EAR INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'FUNGAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'LOCALISED INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HICCUPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 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'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'MILIARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 5}, {'groupId': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "RAYNAUD'S PHENOMENON", 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HERPES ZOSTER DISSEMINATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SARS-COV-2 TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'LOBULAR BREAST CARCINOMA IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CAROTID ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BIPOLAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'UTERINE PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of ocrelizumab (OCR) 300 milligrams (mg) on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: tetanus toxoid (TT) containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine (23-PPV) and repeated administration with keyhole limpet hemocyanin (KLH). In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'normal distribution approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.7', 'ciLowerLimit': '-50.5', 'ciUpperLimit': '-10.8', 'groupDescription': 'Difference in positive response, Group A minus Group B', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'normal distribution approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.4', 'ciLowerLimit': '-56.0', 'ciUpperLimit': '-16.7', 'groupDescription': 'Difference in positive response, Group A minus Group B', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'normal distribution approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.0', 'ciLowerLimit': '-63.2', 'ciUpperLimit': '-30.7', 'groupDescription': 'Difference in positive response, Group A minus Group B', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Mean Levels of Anti-Tetanus Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Pre-Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.680', 'groupId': 'OG000', 'lowerLimit': '1.275', 'upperLimit': '2.214'}, {'value': '2.147', 'groupId': 'OG001', 'lowerLimit': '1.612', 'upperLimit': '2.859'}]}]}, {'title': '4 weeks after TT vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.132', 'groupId': 'OG000', 'lowerLimit': '3.373', 'upperLimit': '5.061'}, {'value': '12.157', 'groupId': 'OG001', 'lowerLimit': '9.498', 'upperLimit': '15.560'}]}]}, {'title': '8 weeks after TT vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.743', 'groupId': 'OG000', 'lowerLimit': '3.048', 'upperLimit': '4.596'}, {'value': '9.812', 'groupId': 'OG001', 'lowerLimit': '7.842', 'upperLimit': '12.277'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to and at 4 and 8 weeks after TT vaccine', 'description': 'Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Immediately prior to first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000', 'lowerLimit': '213', 'upperLimit': '354'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '180', 'upperLimit': '308'}]}]}, {'title': '4 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '384', 'groupId': 'OG000', 'lowerLimit': '285', 'upperLimit': '517'}, {'value': '1086', 'groupId': 'OG001', 'lowerLimit': '769', 'upperLimit': '1534'}]}]}, {'title': '8 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2916', 'groupId': 'OG000', 'lowerLimit': '1998', 'upperLimit': '4253'}, {'value': '17737', 'groupId': 'OG001', 'lowerLimit': '12441', 'upperLimit': '25287'}]}]}, {'title': '12 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5298', 'groupId': 'OG000', 'lowerLimit': '3794', 'upperLimit': '7397'}, {'value': '60270', 'groupId': 'OG001', 'lowerLimit': '43557', 'upperLimit': '83396'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration', 'description': 'Anti-KLH antibody levels were assessed by ELISA.', 'unitOfMeasure': 'titer units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Mean Levels of Anti-KLH Antibody: Ig M', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Immediately prior to first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '122'}, {'value': '130', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '168'}]}]}, {'title': '4 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '155'}, {'value': '217', 'groupId': 'OG001', 'lowerLimit': '158', 'upperLimit': '298'}]}]}, {'title': '8 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000', 'lowerLimit': '273', 'upperLimit': '478'}, {'value': '1086', 'groupId': 'OG001', 'lowerLimit': '797', 'upperLimit': '1481'}]}]}, {'title': '12 weeks after first KLH administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000', 'lowerLimit': '286', 'upperLimit': '483'}, {'value': '1883', 'groupId': 'OG001', 'lowerLimit': '1405', 'upperLimit': '2524'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration', 'description': 'Anti-KLH antibody levels were assessed by ELISA.', 'unitOfMeasure': 'titer units', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '82.4', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '94.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '85.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '82.4', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '85.3', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '82.4', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}, {'value': '94.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.7', 'ciLowerLimit': '-62.7', 'ciUpperLimit': '-38.8', 'groupDescription': 'Serotype 1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.3', 'ciLowerLimit': '-56.5', 'ciUpperLimit': '-30.1', 'groupDescription': 'Serotype 2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.0', 'ciLowerLimit': '-65.2', 'ciUpperLimit': '-30.9', 'groupDescription': 'Serotype 3', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.8', 'ciLowerLimit': '-77.2', 'ciUpperLimit': '-48.4', 'groupDescription': 'Serotype 4', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-53.8', 'ciLowerLimit': '-68.0', 'ciUpperLimit': '-39.7', 'groupDescription': 'Serotype 5', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.5', 'ciLowerLimit': '-54.4', 'ciUpperLimit': '-20.7', 'groupDescription': 'Serotype 6B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.3', 'ciLowerLimit': '-73.1', 'ciUpperLimit': '-43.6', 'groupDescription': 'Serotype 7F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.9', 'ciLowerLimit': '-45.7', 'ciUpperLimit': '-20.1', 'groupDescription': 'Serotype 8', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.4', 'ciLowerLimit': '-62.5', 'ciUpperLimit': '-30.4', 'groupDescription': 'Serotype 9N', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.4', 'ciLowerLimit': '-55.7', 'ciUpperLimit': '-25.1', 'groupDescription': 'Serotype 9V', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.8', 'ciLowerLimit': '-77.2', 'ciUpperLimit': '-48.4', 'groupDescription': 'Serotype 10A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.5', 'ciLowerLimit': '-69.4', 'ciUpperLimit': '-35.6', 'groupDescription': 'Serotype 11A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.6', 'ciLowerLimit': '-72.8', 'ciUpperLimit': '-38.3', 'groupDescription': 'Serotype 12F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.5', 'ciLowerLimit': '-41.4', 'ciUpperLimit': '-9.7', 'groupDescription': 'Serotype 14', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.9', 'ciLowerLimit': '-63.9', 'ciUpperLimit': '-32.0', 'groupDescription': 'Serotype 15B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.9', 'ciLowerLimit': '-72.4', 'ciUpperLimit': '-41.4', 'groupDescription': 'Serotype 17F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.4', 'ciLowerLimit': '-67.4', 'ciUpperLimit': '-37.3', 'groupDescription': 'Serotype 18C', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.4', 'ciLowerLimit': '-62.5', 'ciUpperLimit': '-30.4', 'groupDescription': 'Serotype 19A', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.5', 'ciLowerLimit': '-68.8', 'ciUpperLimit': '-36.1', 'groupDescription': 'Serotype 19F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.5', 'ciLowerLimit': '-77.5', 'ciUpperLimit': '-45.4', 'groupDescription': 'Serotype 20', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.8', 'ciLowerLimit': '-71.7', 'ciUpperLimit': '-42.0', 'groupDescription': 'Serotype 22F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.2', 'ciLowerLimit': '-51.7', 'ciUpperLimit': '-14.6', 'groupDescription': 'Serotype 23F', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.8', 'ciLowerLimit': '-62.2', 'ciUpperLimit': '-33.5', 'groupDescription': 'Serotype 33F', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after 23-PPV', 'description': 'Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (\\>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. 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[{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.68', 'upperLimit': '1.00'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '1.92'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '1.14'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.48'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.41'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '1.64'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '2.20'}, {'value': '2.09', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '3.46'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.89', 'upperLimit': '1.35'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '1.67'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.27', 'upperLimit': '2.29'}, {'value': '1.29', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '1.87'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '0.97'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '1.20'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '0.93'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '1.41'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.22'}, {'value': '0.67', 'groupId': 'OG001', 'lowerLimit': '0.52', 'upperLimit': '0.85'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.67'}, {'value': '11.58', 'groupId': 'OG001', 'lowerLimit': '7.72', 'upperLimit': '17.38'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.79', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '2.30'}, {'value': '9.41', 'groupId': 'OG001', 'lowerLimit': 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Serotype : 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '1.09', 'upperLimit': '1.84'}, {'value': '5.33', 'groupId': 'OG001', 'lowerLimit': '3.63', 'upperLimit': '7.82'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.18', 'upperLimit': '2.03'}, {'value': '7.35', 'groupId': 'OG001', 'lowerLimit': '4.39', 'upperLimit': '12.31'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.47', 'groupId': 'OG000', 'lowerLimit': '1.71', 'upperLimit': '3.55'}, {'value': '8.96', 'groupId': 'OG001', 'lowerLimit': '5.43', 'upperLimit': '14.80'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.57', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '1.95'}, {'value': '5.09', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '7.97'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1.52', 'upperLimit': '2.71'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '2.39', 'upperLimit': '5.86'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.10', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.42'}, {'value': '4.51', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '6.95'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.46'}, {'value': '2.90', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '4.66'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '1.85'}, {'value': '5.11', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '8.05'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to and 4 weeks after 23-PPV', 'description': 'Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A1', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG002', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '97.1', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '85.3', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '97.1', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '82.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '97.1', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 9N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '47.1', 'groupId': 'OG001'}, {'value': '82.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 10A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '91.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 11A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '82.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 12F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}, {'value': '79.4', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '85.3', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 15B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '88.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '85.3', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '91.2', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '76.5', 'groupId': 'OG002'}]}]}, {'title': 'Serotype 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.2', 'ciLowerLimit': '-62.7', 'ciUpperLimit': '-27.6', 'groupDescription': 'Serotype 1- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.2', 'ciLowerLimit': '-60.6', 'ciUpperLimit': '-23.8', 'groupDescription': 'Serotype 2- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.8', 'ciLowerLimit': '-70.4', 'ciUpperLimit': '-29.2', 'groupDescription': 'Serotype 3- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.0', 'ciLowerLimit': '-75.7', 'ciUpperLimit': '-36.3', 'groupDescription': 'Serotype 4- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.3', 'ciLowerLimit': '-76.4', 'ciUpperLimit': '-40.3', 'groupDescription': 'Serotype 5- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.0', 'ciLowerLimit': '-55.7', 'ciUpperLimit': '-12.2', 'groupDescription': 'Serotype 6B- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.5', 'ciLowerLimit': '-61.8', 'ciUpperLimit': '-23.2', 'groupDescription': 'Serotype 7F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.2', 'ciLowerLimit': '-60.6', 'ciUpperLimit': '-23.8', 'groupDescription': 'Serotype 8- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.2', 'ciLowerLimit': '-58.9', 'ciUpperLimit': '-15.5', 'groupDescription': 'Serotype 9N- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.6', 'ciLowerLimit': '-57.3', 'ciUpperLimit': '-16.0', 'groupDescription': 'Serotype 9V- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.1', 'ciLowerLimit': '-80.8', 'ciUpperLimit': '-43.5', 'groupDescription': 'Serotype 10A- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.1', 'ciLowerLimit': '-71.0', 'ciUpperLimit': '-29.2', 'groupDescription': 'Serotype 11A- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.8', 'ciLowerLimit': '-76.9', 'ciUpperLimit': '-36.8', 'groupDescription': 'Serotype 12F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.8', 'ciLowerLimit': '-41.4', 'ciUpperLimit': '-0.2', 'groupDescription': 'Serotype 14- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.8', 'ciLowerLimit': '-72.8', 'ciUpperLimit': '-32.7', 'groupDescription': 'Serotype 15B- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.3', 'ciLowerLimit': '-66.8', 'ciUpperLimit': '-25.8', 'groupDescription': 'Serotype 17F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.5', 'ciLowerLimit': '-61.8', 'ciUpperLimit': '-23.2', 'groupDescription': 'Serotype 18C- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.2', 'ciLowerLimit': '-50.6', 'ciUpperLimit': '-9.7', 'groupDescription': 'Serotype 19A- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.3', 'ciLowerLimit': '-66.8', 'ciUpperLimit': '-25.8', 'groupDescription': 'Serotype 19F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.5', 'ciLowerLimit': '-79.0', 'ciUpperLimit': '-40.0', 'groupDescription': 'Serotype 20- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.5', 'ciLowerLimit': '-72.1', 'ciUpperLimit': '-32.8', 'groupDescription': 'Serotype 22F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.1', 'ciLowerLimit': '-50.7', 'ciUpperLimit': '-5.4', 'groupDescription': 'Serotype 23F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.0', 'ciLowerLimit': '-68.2', 'ciUpperLimit': '-29.7', 'groupDescription': 'Serotype 33F- Difference in positive response, Group A1 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.8', 'ciLowerLimit': '-78.1', 'ciUpperLimit': '-45.4', 'groupDescription': 'Serotype 1- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.9', 'ciLowerLimit': '-70.6', 'ciUpperLimit': '-35.3', 'groupDescription': 'Serotype 2- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.9', 'ciLowerLimit': '-75.3', 'ciUpperLimit': '-36.5', 'groupDescription': 'Serotype 3- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-64.7', 'ciLowerLimit': '-82.6', 'ciUpperLimit': '-46.8', 'groupDescription': 'Serotype 4- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.9', 'ciLowerLimit': '-70.6', 'ciUpperLimit': '-35.3', 'groupDescription': 'Serotype 5- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.2', 'ciLowerLimit': '-59.3', 'ciUpperLimit': '-17.2', 'groupDescription': 'Serotype 6B- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.8', 'ciLowerLimit': '-76.7', 'ciUpperLimit': '-40.9', 'groupDescription': 'Serotype 7F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.4', 'ciLowerLimit': '-46.1', 'ciUpperLimit': '-12.7', 'groupDescription': 'Serotype 8- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.3', 'ciLowerLimit': '-56.4', 'ciUpperLimit': '-14.2', 'groupDescription': 'Serotype 9N- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.2', 'ciLowerLimit': '-58.2', 'ciUpperLimit': '-18.2', 'groupDescription': 'Serotype 9V- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.8', 'ciLowerLimit': '-79.8', 'ciUpperLimit': '-43.7', 'groupDescription': 'Serotype 10A- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.2', 'ciLowerLimit': '-59.3', 'ciUpperLimit': '-17.2', 'groupDescription': 'Serotype 11A- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.8', 'ciLowerLimit': '-78.0', 'ciUpperLimit': '-39.6', 'groupDescription': 'Serotype 12F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.6', 'ciLowerLimit': '-37.4', 'ciUpperLimit': '2.1', 'groupDescription': 'Serotype 14- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.0', 'ciLowerLimit': '-69.6', 'ciUpperLimit': '-30.4', 'groupDescription': 'Serotype 15B- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.1', 'ciLowerLimit': '-64.0', 'ciUpperLimit': '-24.2', 'groupDescription': 'Serotype 17F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.8', 'ciLowerLimit': '-79.4', 'ciUpperLimit': '-44.2', 'groupDescription': 'Serotype 18C- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-52.9', 'ciLowerLimit': '-72.3', 'ciUpperLimit': '-33.6', 'groupDescription': 'Serotype 19A- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-58.8', 'ciLowerLimit': '-77.6', 'ciUpperLimit': '-40.1', 'groupDescription': 'Serotype 19F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.6', 'ciLowerLimit': '-87.4', 'ciUpperLimit': '-53.8', 'groupDescription': 'Serotype 20- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-67.6', 'ciLowerLimit': '-84.8', 'ciUpperLimit': '-50.5', 'groupDescription': 'Serotype 22F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.1', 'ciLowerLimit': '-68.0', 'ciUpperLimit': '-26.1', 'groupDescription': 'Serotype 23F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.0', 'ciLowerLimit': '-68.5', 'ciUpperLimit': '-31.5', 'groupDescription': 'Serotype 33F- Difference in positive response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks after 23-PPV, which 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'0.91'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '1.23'}, {'value': '1.18', 'groupId': 'OG002', 'lowerLimit': '0.73', 'upperLimit': '1.92'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 17F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '1.22'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '1.30'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.75', 'upperLimit': '1.48'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.11', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '1.70'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.46'}, {'value': '1.14', 'groupId': 'OG002', 'lowerLimit': '0.79', 'upperLimit': '1.64'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.74'}, {'value': '1.99', 'groupId': 'OG001', 'lowerLimit': '1.15', 'upperLimit': '3.43'}, {'value': '2.09', 'groupId': 'OG002', 'lowerLimit': '1.26', 'upperLimit': '3.46'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '1.41'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '1.53'}, {'value': '1.16', 'groupId': 'OG002', 'lowerLimit': '0.80', 'upperLimit': '1.67'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.38', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '2.06'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.39', 'upperLimit': '3.25'}, {'value': '1.29', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '1.87'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.78'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.60', 'upperLimit': '1.59'}, {'value': '0.82', 'groupId': 'OG002', 'lowerLimit': '0.55', 'upperLimit': '1.20'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '0.91'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.20'}, {'value': '0.96', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '1.41'}]}]}, {'title': 'Immediately prior to 23-PPV: Serotype : 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.22'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.46'}, {'value': '0.67', 'groupId': 'OG002', 'lowerLimit': '0.52', 'upperLimit': '0.85'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.62'}, {'value': '1.46', 'groupId': 'OG001', 'lowerLimit': '1.04', 'upperLimit': '2.06'}, {'value': '11.58', 'groupId': 'OG002', 'lowerLimit': '7.72', 'upperLimit': '17.38'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '2.57'}, {'value': '1.79', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '2.56'}, {'value': '9.41', 'groupId': 'OG002', 'lowerLimit': '6.80', 'upperLimit': '13.01'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '2.23'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '2.38'}, {'value': '2.76', 'groupId': 'OG002', 'lowerLimit': '1.72', 'upperLimit': '4.42'}]}]}, {'title': '4 weeks after 23-PPV: Serotype : 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.15', 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'groupId': 'OG000', 'lowerLimit': '1.54', 'upperLimit': '3.40'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '1.62'}, {'value': '7.14', 'groupId': 'OG002', 'lowerLimit': '4.37', 'upperLimit': '11.65'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.35', 'groupId': 'OG000', 'lowerLimit': '1.53', 'upperLimit': '3.59'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '5.84'}, {'value': '9.56', 'groupId': 'OG002', 'lowerLimit': '5.87', 'upperLimit': '15.56'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.30', 'upperLimit': '2.33'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '2.24'}, {'value': '4.91', 'groupId': 'OG002', 'lowerLimit': '3.12', 'upperLimit': '7.73'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '2.66'}, {'value': '2.59', 'groupId': 'OG001', 'lowerLimit': '1.71', 'upperLimit': '3.92'}, {'value': '3.56', 'groupId': 'OG002', 'lowerLimit': '2.31', 'upperLimit': '5.50'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 22F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '2.12'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '1.50'}, {'value': '4.69', 'groupId': 'OG002', 'lowerLimit': '3.11', 'upperLimit': '7.09'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '1.77'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.79', 'upperLimit': '1.44'}, {'value': '2.44', 'groupId': 'OG002', 'lowerLimit': '1.58', 'upperLimit': '3.76'}]}]}, {'title': '8 weeks after 23-PPV: Serotype : 33F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.92'}, {'value': '1.68', 'groupId': 'OG001', 'lowerLimit': '1.23', 'upperLimit': '2.30'}, {'value': '5.01', 'groupId': 'OG002', 'lowerLimit': '3.16', 'upperLimit': '7.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV', 'description': 'Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroprotection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '80.6', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '92.6', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.5', 'ciLowerLimit': '-41.6', 'ciUpperLimit': '-9.5', 'groupDescription': 'Strain = H1N1CA09 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.0', 'ciLowerLimit': '-35.2', 'ciUpperLimit': '7.3', 'groupDescription': 'Strain = BPHU13 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.9', 'ciLowerLimit': '-45.5', 'ciUpperLimit': '-6.4', 'groupDescription': 'Strain = H3N2SW13 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-50.7', 'ciUpperLimit': '11.8', 'groupDescription': 'Strain = BBRIS08 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-49.4', 'ciUpperLimit': '42.7', 'groupDescription': 'Strain = AHK4801 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': 'Seroprotection was defined as specific hemagglutination inhibition (HI) titers \\>40 at 4 weeks after vaccination.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '96.2', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '73.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.8', 'ciLowerLimit': '-61.9', 'ciUpperLimit': '-21.7', 'groupDescription': 'Strain = H1N1CA09 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.6', 'ciLowerLimit': '-59.7', 'ciUpperLimit': '-15.5', 'groupDescription': 'Strain = BPHU13 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.5', 'ciLowerLimit': '-78.2', 'ciUpperLimit': '-40.7', 'groupDescription': 'Strain = H3N2SW13 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.6', 'ciLowerLimit': '-76.0', 'ciUpperLimit': '-15.1', 'groupDescription': 'Strain = BBRIS08 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-49.4', 'ciUpperLimit': '42.7', 'groupDescription': 'Strain = AHK4801 (Group A2 minus Group B)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': '2-fold increase from prevaccination HI titer.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.3', 'ciLowerLimit': '-80.2', 'ciUpperLimit': '-42.3', 'groupDescription': 'Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.8', 'ciLowerLimit': '-75.3', 'ciUpperLimit': '-34.4', 'groupDescription': 'Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-82.3', 'ciLowerLimit': '-97.1', 'ciUpperLimit': '-67.5', 'groupDescription': 'Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.7', 'ciLowerLimit': '-67.2', 'ciUpperLimit': '-6.1', 'groupDescription': 'Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-63.8', 'ciUpperLimit': '50.5', 'groupDescription': 'Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': '4-fold increase from prevaccination HI titer.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Strain = H1N1CA09 (as per FDA guidance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H1N1CA09 (as per protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13 (as per FDA guidance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13 (as per protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13 (as per FDA guidance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '88.5', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13 (as per protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '77.8', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08 (as per FDA guidance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '53.3', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08 (as per protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801 (as per FDA guidance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801 (as per protocol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.3', 'ciLowerLimit': '-80.2', 'ciUpperLimit': '-42.3', 'groupDescription': 'Strain = H1N1CA09 (Group A2 minus Group B) \\[FDA\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.0', 'ciLowerLimit': '-88.0', 'ciUpperLimit': '-4.0', 'groupDescription': 'Strain = H1N1CA09 (Group A2 minus Group B) \\[Protocol\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.9', 'ciLowerLimit': '-77.7', 'ciUpperLimit': '-38.1', 'groupDescription': 'Strain = BPHU13 (Group A2 minus Group B) \\[FDA\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.6', 'ciLowerLimit': '-88.0', 'ciUpperLimit': '-23.1', 'groupDescription': 'Strain = BPHU13 (Group A2 minus Group B) \\[Protocol\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-78.5', 'ciLowerLimit': '-94.8', 'ciUpperLimit': '-62.2', 'groupDescription': 'Strain = H3N2SW13 (Group A2 minus Group B) \\[FDA\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.8', 'ciLowerLimit': '-100.0', 'ciUpperLimit': '-13.4', 'groupDescription': 'Strain = H3N2SW13 (Group A2 minus Group B) \\[Protocol\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.7', 'ciLowerLimit': '-67.2', 'ciUpperLimit': '-6.1', 'groupDescription': 'Strain = BBRIS08 (Group A2 minus Group B) \\[FDA\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.0', 'ciLowerLimit': '-67.4', 'ciUpperLimit': '17.4', 'groupDescription': 'Strain = BBRIS08 (Group A2 minus Group B) \\[Protocol\\]', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Normal Distribution Approximation', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-63.8', 'ciUpperLimit': '50.5', 'groupDescription': 'Strain = AHK4801 (Group A2 minus Group B) \\[FDA\\]', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after influenza immunization', 'description': 'Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer \\<10 and an HI titer \\>40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer \\<10 and HI titer \\>/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer \\>/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Strain-Specific Geometric Mean Titer Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Prior to influenza vaccine: Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.5', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '204.4'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '133.6'}]}]}, {'title': '4 weeks after influenza vaccine: Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '154.8', 'groupId': 'OG000', 'lowerLimit': '103.8', 'upperLimit': '230.8'}, {'value': '390.8', 'groupId': 'OG001', 'lowerLimit': '264.0', 'upperLimit': '578.4'}]}]}, {'title': 'Prior to influenza vaccine: Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '92.4'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '84.3'}]}]}, {'title': '4 weeks after influenza vaccine: Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '64.3', 'upperLimit': '111.3'}, {'value': '243.1', 'groupId': 'OG001', 'lowerLimit': '156.3', 'upperLimit': '377.9'}]}]}, {'title': 'Prior to influenza vaccine: Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.0', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '166.0'}, {'value': '62.6', 'groupId': 'OG001', 'lowerLimit': '41.2', 'upperLimit': '95.2'}]}]}, {'title': '4 weeks after influenza vaccine: Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134.5', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '190.5'}, {'value': '342.8', 'groupId': 'OG001', 'lowerLimit': '219.1', 'upperLimit': '536.3'}]}]}, {'title': 'Prior to influenza vaccine: Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '69.0'}, {'value': '71.3', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '142.3'}]}]}, {'title': '4 weeks after influenza vaccine: Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '99.3'}, {'value': '311.7', 'groupId': 'OG001', 'lowerLimit': '167.4', 'upperLimit': '580.5'}]}]}, {'title': 'Prior to influenza vaccine: Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '132.6'}, {'value': '45.9', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '65.2'}]}]}, {'title': '4 weeks after influenza vaccine: Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.3', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '208.8'}, {'value': '127.0', 'groupId': 'OG001', 'lowerLimit': '55.1', 'upperLimit': '292.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.', 'unitOfMeasure': 'hemagglutination inhibition titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Strain = H1N1CA09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '5.74', 'spread': '21.05', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BPHU13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.35', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '6.45', 'spread': '28.31', 'groupId': 'OG001'}]}]}, {'title': 'Strain = H3N2SW13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '11.70', 'groupId': 'OG001'}]}]}, {'title': 'Strain = BBRIS08', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '9.19', 'groupId': 'OG001'}]}]}, {'title': 'Strain = AHK4801', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '3.34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Immediately prior to and 4 weeks after influenza vaccine', 'description': 'Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).'}, {'type': 'SECONDARY', 'title': 'Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.76', 'spread': '13.31', 'groupId': 'OG000'}, {'value': '7.53', 'spread': '8.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'cubic centimeters (cm^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Number of T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.94', 'spread': '45.43', 'groupId': 'OG000'}, {'value': '45.53', 'spread': '28.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Categorical Number of T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Baseline: 0-5 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 6-9 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: >9 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '10.93', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '2.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Baseline: 0 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 1 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 3 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: >=4 lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Normalized Brain Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1470.51', 'spread': '77.83', 'groupId': 'OG000'}, {'value': '1456.35', 'spread': '70.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Volume of T2 Lesions: White Matter Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '808.22', 'spread': '60.11', 'groupId': 'OG000'}, {'value': '794.53', 'spread': '47.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Cortical Grey Matter Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '521.19', 'spread': '35.28', 'groupId': 'OG000'}, {'value': '519.70', 'spread': '36.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: T1 Unenhancing Lesion Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'MRI Parameters: Total Number of Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.51', 'spread': '27.76', 'groupId': 'OG000'}, {'value': '18.85', 'spread': '15.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OC population included all randomized participants who completed the ISP.'}, {'type': 'SECONDARY', 'title': 'Cellular Immune Response Assessed by Flow Cytometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': '>=lower limit of normal range (LLN) - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000'}, {'value': '97.0', 'groupId': 'OG001'}]}]}, {'title': '<LLN - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'CD19 repleted - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'CD19 not repleted - Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>=LLN - Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '<LLN - Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'CD19 repleted - Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CD19 not repleted - Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': '>=LLN - Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}]}]}, {'title': '<LLN - Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'CD19 repleted - Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}]}]}, {'title': 'CD19 not repleted - Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': '>=LLN - Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '<LLN - Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'CD19 repleted - Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CD19 not repleted - Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': '>=LLN - Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': '<LLN - Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'CD19 repleted - Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'CD19 not repleted - Day 140', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': '>=LLN - Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': '<LLN - Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}, {'title': 'CD19 repleted - Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'CD19 not repleted - Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 15, 85, 112, 140 and 169', 'description': 'Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul.\n\nRepleted is defined as CD19 \\>= LLN or baseline, whichever is lower.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Total Immunoglobulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.45', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '14.05', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.45', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '14.53', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.26', 'spread': '2.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 85, and 169', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any ocrelizumab or any vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibody Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 Weeks (ISP)', 'description': 'Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (A1 + A2)', 'description': 'Participants received dual infusion of OCR 300 mg on Days 1 and 15, and then further received the following immunization course during the period from Week 12 to Week 24: TT containing adsorbed vaccine, 23-PPV and repeated administration with KLH. In addition, only Group A1 received 13-valent pneumococcal conjugate vaccine (13-PCV, booster to 23-PPV) and only Group A2 received influenza vaccine.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Study Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During ISP (24 weeks for Group A and 12 weeks for Group B)', 'description': "An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received any ocrelizumab or any vaccine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A1', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'FG001', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'FG002', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Treatment change', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The study recruited participants with relapsing forms of multiple sclerosis in 2 countries from 27 October 2015 to 14 February 2017.', 'preAssignmentDetails': 'A total of 122 participants were screened of which 102 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A1', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'BG001', 'title': 'Group A2', 'description': 'Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24.'}, {'id': 'BG002', 'title': 'Group B', 'description': 'Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '41.4', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '8.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Observed Cases (OC) Population was defined as all randomized participants who completed the ISP.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-02', 'size': 1439169, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-19T12:54', 'hasProtocol': True}, {'date': '2016-11-07', 'size': 386480, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-09T08:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2015-09-08', 'resultsFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2015-09-08', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-02', 'studyFirstPostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine', 'timeFrame': '8 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine', 'timeFrame': '4 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.'}, {'measure': 'Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers', 'timeFrame': '4 weeks after TT vaccine', 'description': 'For participants with pre-vaccination tetanus antibody titers \\< 0.1 IU/mL, a positive response was defined as an antibody titer \\>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \\>/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.'}, {'measure': 'Mean Levels of Anti-Tetanus Antibody', 'timeFrame': 'Immediately prior to and at 4 and 8 weeks after TT vaccine', 'description': 'Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G', 'timeFrame': 'Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration', 'description': 'Anti-KLH antibody levels were assessed by ELISA.'}, {'measure': 'Mean Levels of Anti-KLH Antibody: Ig M', 'timeFrame': 'Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration', 'description': 'Anti-KLH antibody levels were assessed by ELISA.'}, {'measure': 'Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV', 'timeFrame': '4 weeks after 23-PPV', 'description': 'Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (\\>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.'}, {'measure': 'Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes', 'timeFrame': '4 weeks after 23-PPV', 'description': 'Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \\> 1 mcg/mL rise compared with pre-vaccination levels.'}, {'measure': 'Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes', 'timeFrame': '4 weeks after 23-PPV', 'description': 'Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \\> 1 mcg/mL rise compared with pre-vaccination levels.'}, {'measure': 'Mean Levels of Anti-Pneumococcal Antibody', 'timeFrame': 'Immediately prior to and 4 weeks after 23-PPV', 'description': 'Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).'}, {'measure': 'Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV', 'timeFrame': '8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV', 'description': 'Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \\> 1 mcg/mL rise compared with pre-vaccination levels.'}, {'measure': 'Mean Level of Anti-Pneumococcal Antibody', 'timeFrame': 'Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV', 'description': 'Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).'}, {'measure': 'Percentage of Participants With Seroprotection', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': 'Seroprotection was defined as specific hemagglutination inhibition (HI) titers \\>40 at 4 weeks after vaccination.'}, {'measure': 'Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': '2-fold increase from prevaccination HI titer.'}, {'measure': 'Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers', 'timeFrame': '4 weeks after seasonal influenza vaccine administration', 'description': '4-fold increase from prevaccination HI titer.'}, {'measure': 'Percentage of Participants With Seroconversion', 'timeFrame': '4 weeks after influenza immunization', 'description': 'Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer \\<10 and an HI titer \\>40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer \\<10 and HI titer \\>/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer \\>/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.'}, {'measure': 'Strain-Specific Geometric Mean Titer Levels', 'timeFrame': 'Baseline and Week 4', 'description': 'Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.'}, {'measure': 'Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination', 'timeFrame': 'Immediately prior to and 4 weeks after influenza vaccine', 'description': 'Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.'}, {'measure': 'Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Number of T2 Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Categorical Number of T2 Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Normalized Brain Volume', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Volume of T2 Lesions: White Matter Volume', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Cortical Grey Matter Volume', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: T1 Unenhancing Lesion Volume', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'MRI Parameters: Total Number of Lesions', 'timeFrame': 'Baseline', 'description': 'MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.'}, {'measure': 'Cellular Immune Response Assessed by Flow Cytometry', 'timeFrame': 'Days 1, 15, 85, 112, 140 and 169', 'description': 'Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul.\n\nRepleted is defined as CD19 \\>= LLN or baseline, whichever is lower.'}, {'measure': 'Total Immunoglobulin', 'timeFrame': 'Days 1, 85, and 169'}, {'measure': 'Percentage of Participants With Anti-Drug Antibody Formation', 'timeFrame': 'Up to 24 Weeks (ISP)', 'description': 'Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation', 'timeFrame': 'During ISP (24 weeks for Group A and 12 weeks for Group B)', 'description': "An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '32727835', 'type': 'DERIVED', 'citation': 'Bar-Or A, Calkwood JC, Chognot C, Evershed J, Fox EJ, Herman A, Manfrini M, McNamara J, Robertson DS, Stokmaier D, Wendt JK, Winthrop KL, Traboulsee A. Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study. Neurology. 2020 Oct 6;95(14):e1999-e2008. doi: 10.1212/WNL.0000000000010380. Epub 2020 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \\[TT\\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \\[23-PPV\\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \\[13-PCV\\], influenza vaccine, keyhole limpet hemocyanin \\[KLH\\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RMS in accordance with the revised McDonald criteria\n* Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap)\n* Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive\n* For sexually active female participants of reproductive potential, use of reliable means of contraception\n\nExclusion Criteria:\n\n* Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label\n* Known presence of other neurologic disorders\n* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT02545868', 'briefTitle': 'A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'BN29739'}, 'secondaryIdInfos': [{'id': '2015-001357-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: OCR + Vaccines', 'description': 'Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period.', 'interventionNames': ['Biological: 23-PPV', 'Biological: 13-PCV Booster', 'Biological: Influenza Vaccine', 'Biological: KLH', 'Drug: OCR', 'Biological: TT Vaccine']}, {'type': 'OTHER', 'label': 'Group B: Vaccines (Optional OCR in Extension)', 'description': 'Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period.', 'interventionNames': ['Biological: 23-PPV', 'Biological: Influenza Vaccine', 'Biological: KLH', 'Drug: OCR', 'Biological: TT Vaccine']}], 'interventions': [{'name': '23-PPV', 'type': 'BIOLOGICAL', 'description': 'The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).', 'armGroupLabels': ['Group A: OCR + Vaccines', 'Group B: Vaccines (Optional OCR in Extension)']}, {'name': '13-PCV Booster', 'type': 'BIOLOGICAL', 'description': 'The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).', 'armGroupLabels': ['Group A: OCR + Vaccines']}, {'name': 'Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).', 'armGroupLabels': ['Group A: OCR + Vaccines', 'Group B: Vaccines (Optional OCR in Extension)']}, {'name': 'KLH', 'type': 'BIOLOGICAL', 'description': 'KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).', 'armGroupLabels': ['Group A: OCR + Vaccines', 'Group B: Vaccines (Optional OCR in Extension)']}, {'name': 'OCR', 'type': 'DRUG', 'otherNames': ['RO4964913, PRO70769, rhuMAb 2H7'], 'description': 'OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.', 'armGroupLabels': ['Group A: OCR + Vaccines', 'Group B: Vaccines (Optional OCR in Extension)']}, {'name': 'TT Vaccine', 'type': 'BIOLOGICAL', 'description': 'The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).', 'armGroupLabels': ['Group A: OCR + Vaccines', 'Group B: Vaccines (Optional OCR in Extension)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Territory Neurology and Research Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Fullerton Neurology and Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute for Neurological Disorders', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Minneapolis Clinic of Neurology', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital St. Louis / Mercy Clinic Neurology', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Cleveland Clinic Lou Ruvo; Center for Brain Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10306', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island Univ Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Neurology Associates PA', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health Research Institute Grant Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43082', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'MDH Research LLC', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Neurology Clinic PC', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Neurology Consultants', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain MS Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104-1360', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6T 2B5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia Hospital; Division of Neurology', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}