Viewing Study NCT03579459

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Ignite Creation Date: 2025-12-24 @ 3:06 PM

Ignite Modification Date: 2026-01-01 @ 8:31 PM

Study NCT ID: NCT03579459

Status: COMPLETED

Last Update Posted: 2023-01-19

First Post: 2018-06-25

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Local reactions and systemic events (systematic assessment): within 7 days after vaccination. SAEs and other AEs: From Day 1 to 1 month after last vaccination (Up to Month 7)', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis population was evaluated. Pooled data for Clostridium difficile vaccine (lot 1+lot 2+lot 3) is reported as pre-specified in the statistical analysis plan.', 'eventGroups': [{'id': 'EG000', 'title': 'Clostridium Difficile Vaccine (Pooled Lots)', 'description': 'Participants received Clostridium difficile vaccine (200 microgram total toxoid per dose) Lot 1, Lot 2 or Lot 3 intramuscularly at Months 0, 1 and 6.', 'otherNumAtRisk': 983, 'deathsNumAtRisk': 983, 'otherNumAffected': 694, 'seriousNumAtRisk': 983, 'deathsNumAffected': 2, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.', 'otherNumAtRisk': 331, 'deathsNumAtRisk': 331, 'otherNumAffected': 175, 'seriousNumAtRisk': 331, 'deathsNumAffected': 2, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vomiting (VOMITING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fatigue (FATIGUE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 369}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 96}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Injection site erythema (REDNESS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Injection site pain (PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 413}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Injection site swelling (SWELLING)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pyrexia (FEVER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia (JOINT PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 35}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Myalgia (MUSCLE PAIN)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Headache (HEADACHE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 276}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 64}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vascular graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Limb mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Foot operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 983, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 331, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Toxin A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '878.8', 'groupId': 'OG000', 'lowerLimit': '786.3', 'upperLimit': '982.2'}, {'value': '873.0', 'groupId': 'OG001', 'lowerLimit': '779.2', 'upperLimit': '978.1'}, {'value': '872.9', 'groupId': 'OG002', 'lowerLimit': '782.6', 'upperLimit': '973.5'}]}]}, {'title': 'Toxin B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5823.9', 'groupId': 'OG000', 'lowerLimit': '5041.0', 'upperLimit': '6728.4'}, {'value': '5462.8', 'groupId': 'OG001', 'lowerLimit': '4733.4', 'upperLimit': '6304.7'}, {'value': '5426.0', 'groupId': 'OG002', 'lowerLimit': '4724.4', 'upperLimit': '6231.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean ratio (GMR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.18', 'estimateComment': 'Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin A', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.18', 'estimateComment': 'CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin A', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.17', 'estimateComment': 'CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin A', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.31', 'estimateComment': 'CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin B', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.31', 'estimateComment': 'CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin B', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.23', 'estimateComment': 'CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations', 'groupDescription': 'Toxin B', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7', 'description': 'GMC was calculated as the mean of the assay results after making the logarithm transformation and then back transformation to its original scale. Confidence intervals (CIs) were back transformations of CIs based on the Student t distribution for the mean logarithm of the concentrations. Clostridium difficile toxin A and toxin B were inactivated by a combination of genetic mutations to decrease toxin activity and chemical treatments were done prior to final purification and formulation of the drug substance.', 'unitOfMeasure': 'Neutralization units per mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable immunogenicity(EI)population=enrolled participants who received all 3 doses of investigational product to which they were randomized; blood drawn for analysis within 23-47 days after visit 4(Month 6)had valid, determinate assay results for either toxinA or B for specified analysis and no major protocol deviations. Placebo arm is not reported as GMC was planned to be evaluated only for 3 vaccine lots. Here,'Number Analyzed' refers to number of participants evaluable for specific toxins."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}, {'value': '325', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '18.4'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '20.4'}, {'value': '17.4', 'groupId': 'OG002', 'lowerLimit': '13.4', 'upperLimit': '22.0'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '7.9'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Pain at injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.6'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '4.4'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.2'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.6'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.2'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 1 at Month 0', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (\\>) 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}, {'value': '313', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '17.7', 'upperLimit': '27.1'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '32.2'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '17.5', 'upperLimit': '27.0'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '7.0'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '4.5'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '5.5'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.7'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Pain at injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.1'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.7'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.2'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '4.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.2'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.1'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.7'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '4.1'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.7'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 2 at Month 1', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '27.7'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '28.6'}, {'value': '27.9', 'groupId': 'OG002', 'lowerLimit': '22.8', 'upperLimit': '33.3'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '5.1'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.9'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '4.4'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '3.4'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Pain at injection site: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '6.6'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '4.3'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.4'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '4.4'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.4'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Redness: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.9'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '9.1'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '6.5'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.4'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.0'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '5.3'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.9'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Swelling: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 3 at Month 6', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}, {'value': '325', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Fever: 38.0-38.4 deg C', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: 38.5-38.9 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: 39.0-40.0 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: >40 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '15.5'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '14.7'}, {'value': '14.0', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '17.9'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '11.6'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '15.8'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '12.6'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '13.1'}, {'value': '10.2', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '13.7'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fatigue: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '17.1'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '15.0'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '9.6'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': '10.9'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '6.3'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '6.7'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '8.2'}, {'value': '3.4', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '5.9'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '7.8'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '6.4'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '6.7'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '4.3'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '6.3'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '5.2'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '7.1'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '5.5'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '7.4'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.6'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '5.9'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '8.1'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '7.4'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '7.5'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '5.5'}, {'value': '4.6', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '7.4'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 1 at Month 0', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius \\[deg C\\]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}, {'value': '313', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Fever: 38.0-38.4 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: 38.5-38.9 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: 39.0-40.0 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fever: >40 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '14.1'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '14.7'}, {'value': '10.8', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '14.6'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '7.6'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '13.0'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '12.2'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '13.9'}, {'value': '6.4', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '9.4'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '2.7'}]}]}, {'title': 'Fatigue: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '11.6'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '14.0'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '12.1'}, {'value': '5.8', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '8.7'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '7.2'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.5'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '7.6'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '5.6'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '7.6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '8.1'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '5.7'}, {'value': '1.6', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '3.6'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '7.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.5'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '5.3'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '4.4'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '6.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '7.3'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.5'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '4.4'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '8.3'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.7'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '7.3'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '3.1'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.2'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.2'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}, {'title': 'Vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 2 at Month 1', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '303', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Fever: 38.0-38.4 deg C', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Fever: 38.5-38.9 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.3'}]}]}, {'title': 'Fever: 39.0-40.0 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Fever: >40 deg C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '14.1'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '11.9'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '14.0'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '7.9'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '14.1'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '11.1'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '8.7'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': '12.1'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Fatigue: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '16.3'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '12.2'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '10.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '3.5', 'upperLimit': '9.1'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '5.9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '6.4'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '3.7'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Headache: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '4.2'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '5.5'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.8'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '5.1'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.3'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Joint pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '5.5'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.5'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '7.9'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '5.1'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '4.7'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '4.2'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '5.5'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '3.7'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Muscle pain: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.7', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.3'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}, {'title': 'Vomiting: Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after Vaccination 3 at Month 6', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Through 1 Month After Last Study Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine (Pooled Lots)', 'description': 'Participants received Clostridium difficile vaccine (200 microgram total toxoid per dose) Lot 1, Lot 2 or Lot 3 intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}]}]}, {'title': 'NSAEs', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to 1 month after last vaccination (Up to Month 7)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events (NSAEs). Only AEs and NSAEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Pooled data for Clostridium difficile vaccine (lot 1+lot 2+lot 3) is reported for this outcome measure as pre-specified in the statistical analysis plan.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clostridium Difficile Vaccine (Pooled Lots)', 'description': 'Participants received Clostridium difficile vaccine (200 microgram total toxoid per dose) Lot 1, Lot 2 or Lot 3 intramuscularly at Months 0, 1 and 6.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to 1 month after last vaccination (Up to Month 7)', 'description': 'An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product. Pooled data for Clostridium difficile vaccine (lot 1+lot 2+lot 3) is reported for this outcome measure as pre-specified in the statistical analysis plan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants were randomized to receive Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'FG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants were randomized to receive Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'FG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants were randomized to receive Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants were randomized to receive placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '327'}, {'groupId': 'FG002', 'numSubjects': '328'}, {'groupId': 'FG003', 'numSubjects': '332'}]}, {'type': 'Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '325'}, {'groupId': 'FG002', 'numSubjects': '328'}, {'groupId': 'FG003', 'numSubjects': '331'}]}, {'type': 'Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '318'}, {'groupId': 'FG002', 'numSubjects': '319'}, {'groupId': 'FG003', 'numSubjects': '322'}]}, {'type': 'Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '305'}, {'groupId': 'FG002', 'numSubjects': '307'}, {'groupId': 'FG003', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '305'}, {'groupId': 'FG003', 'numSubjects': '308'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Medication error without associated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1358 participants signed the informed consent form (ICF). 41 participants were screen failures who did not meet eligibility criteria and were not enrolled. Out of 1317 randomized participants, only 1314 participants received at least one 1 dose of the investigational product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}, {'value': '1314', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Clostridium Difficile Vaccine: Lot 1', 'description': 'Participants received Clostridium difficile vaccine Lot 1 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'BG001', 'title': 'Clostridium Difficile Vaccine: Lot 2', 'description': 'Participants received Clostridium difficile vaccine Lot 2 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'BG002', 'title': 'Clostridium Difficile Vaccine: Lot 3', 'description': 'Participants received Clostridium difficile vaccine Lot 3 (200 microgram total toxoid per dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo (0.9% sodium chloride injection, in a 0.5 mL dose) intramuscularly at Months 0, 1 and 6.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '5.01', 'groupId': 'BG000'}, {'value': '72.0', 'spread': '5.03', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '4.83', 'groupId': 'BG002'}, {'value': '72.1', 'spread': '4.99', 'groupId': 'BG003'}, {'value': '71.7', 'spread': '4.97', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}, {'value': '739', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '575', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}, {'value': '1176', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}, {'value': '292', 'groupId': 'BG003'}, {'value': '1151', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of the investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-08', 'size': 3271109, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-01T19:35', 'hasProtocol': True}, {'date': '2020-05-13', 'size': 4437444, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-01T19:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2018-06-25', 'resultsFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-21', 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7', 'timeFrame': 'At Month 7', 'description': 'GMC was calculated as the mean of the assay results after making the logarithm transformation and then back transformation to its original scale. Confidence intervals (CIs) were back transformations of CIs based on the Student t distribution for the mean logarithm of the concentrations. Clostridium difficile toxin A and toxin B were inactivated by a combination of genetic mutations to decrease toxin activity and chemical treatments were done prior to final purification and formulation of the drug substance.'}, {'measure': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1', 'timeFrame': 'Within 7 days after Vaccination 1 at Month 0', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (\\>) 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2', 'timeFrame': 'Within 7 days after Vaccination 2 at Month 1', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3', 'timeFrame': 'Within 7 days after Vaccination 3 at Month 6', 'description': "Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Redness and swelling were measured and recorded in measuring device units. One measuring device unit= 0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \\> 5.0 to 10.0 cm, severe: \\>10.0 cm, Grade 4 indicated necrosis or exfoliative dermatitis for redness and necrosis for swelling. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1', 'timeFrame': 'Within 7 days after Vaccination 1 at Month 0', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 degree Celsius \\[deg C\\]), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2', 'timeFrame': 'Within 7 days after Vaccination 2 at Month 1', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3', 'timeFrame': 'Within 7 days after Vaccination 3 at Month 6', 'description': "Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild: (38.0 to 38.4 deg C), moderate: (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C), grade 4: \\>40 deg C. Fatigue, headache, joint pain and muscle pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily activity, grade 4: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours, moderate: \\>2 times in 24 hours, severe: required intravenous hydration, grade 4: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination. Events were classified as Grade 4 based on study investigator's judgement."}, {'measure': 'Percentage of Participants With Adverse Events (AEs) Through 1 Month After Last Study Vaccination', 'timeFrame': 'From Day 1 to 1 month after last vaccination (Up to Month 7)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and all non-serious adverse events (NSAEs). Only AEs and NSAEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.'}, {'measure': 'Percentage of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 to 1 month after last vaccination (Up to Month 7)', 'description': 'An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium Difficile', 'vaccine'], 'conditions': ['Clostridium Difficile Associated Disease']}, 'referencesModule': {'references': [{'pmid': '37977942', 'type': 'DERIVED', 'citation': 'Christensen S, Bouguermouh S, Ilangovan K, Pride MW, Webber C, Lockhart SP, Shah R, Kitchin N, Lamberth E, Zhang H, Gao Q, Brock L, Anderson AS, Gruber WC. A phase 3 study evaluating the lot consistency, immunogenicity, safety, and tolerability of a Clostridioides difficile vaccine in healthy adults 65 to 85 years of age. Vaccine. 2023 Dec 7;41(50):7548-7559. doi: 10.1016/j.vaccine.2023.11.003. Epub 2023 Nov 17.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B5091008', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.", 'detailedDescription': 'Serology for B5091008 was delayed due to discussions with the FDA on statistical analysis as well as delays attributed to the COVID pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with study procedures.\n* Healthy adults 65 to 85 years of age.\n* Male subjects or female subjects who are not of childbearing potential.\n* Ability to be contacted by telephone during study participation.\n\nExclusion Criteria:\n\n* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry through conclusion of the study.\n* Previous administration of an investigational C difficile vaccine or C difficile monoclonal antibody therapy.\n* Proven or suspected prior episode of C difficile infection.\n* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of investigational product.\n* Serious chronic medical disorders, including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease.\n* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.\n* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.\n* Subjects who may be unable to respond to vaccination due to:\n\n * Congenital or acquired immunodeficiency.\n * Receipt of systemic corticosteroids (greater than or equal to 20 mg/day of prednisone or equivalent) for greater than or equal to 14 days within 28 days of enrollment.\n * Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.\n * Underlying bone marrow disorder treated within the past year, such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.\n * Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.\n* Receipt of blood products or immunoglobulins within 6 months before enrollment through conclusion of the study.\n* Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living. An ambulatory subject who lives in an autonomous manner in a retirement home or village is eligible for the trial.\n* A known infection with human immunodeficiency virus (HIV).\n* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavioral or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.\n* Female subjects of childbearing potential; pregnant female subjects; breastfeeding female subjects; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.'}, 'identificationModule': {'nctId': 'NCT03579459', 'briefTitle': 'Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS 65 TO 85 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'B5091008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clostridium difficile vaccine Lot 1', 'interventionNames': ['Biological: Clostridium difficile vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clostridium difficile vaccine Lot 2', 'interventionNames': ['Biological: Clostridium difficile vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clostridium difficile vaccine Lot 3', 'interventionNames': ['Biological: Clostridium difficile vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline solution (0.9% sodium chloride)', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'Clostridium difficile vaccine', 'type': 'BIOLOGICAL', 'description': 'Toxoid based Clostridium difficile vaccine', 'armGroupLabels': ['Clostridium difficile vaccine Lot 1', 'Clostridium difficile vaccine Lot 2', 'Clostridium difficile vaccine Lot 3']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'otherNames': ['0.9% sodium chloride'], 'description': 'Normal saline solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '96001', 'city': 'Redding', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical Research Centers, Inc.', 'geoPoint': {'lat': 40.58654, 'lon': -122.39168}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America, LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research Associates, LLC', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08869', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amici Clinical Research', 'geoPoint': 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Lewis Research Inc. / Foothill Family Clinic Draper', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc./ Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Incorporated/Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Jordan River Family Medicine', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}