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Ignite Creation Date: 2025-12-24 @ 11:38 PM

Ignite Modification Date: 2026-02-24 @ 2:30 PM

Study NCT ID: NCT04091451

Status: COMPLETED

Last Update Posted: 2025-12-04

First Post: 2019-09-03

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Estonia', 'Finland', 'Hong Kong', 'Mexico', 'Panama', 'Spain', 'United Kingdom', 'United States'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).', 'description': 'All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames.\n\nAll SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.', 'eventGroups': [{'id': 'EG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.', 'otherNumAtRisk': 714, 'deathsNumAtRisk': 714, 'otherNumAffected': 665, 'seriousNumAtRisk': 714, 'deathsNumAffected': 12, 'seriousNumAffected': 56}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.', 'otherNumAtRisk': 712, 'deathsNumAtRisk': 712, 'otherNumAffected': 414, 'seriousNumAtRisk': 712, 'deathsNumAffected': 8, 'seriousNumAffected': 43}], 'otherEvents': [{'term': 'Administration site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1065, 'numAffected': 611}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 109, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 695, 'numAffected': 457}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 262, 'numAffected': 199}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 584, 'numAffected': 396}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 139, 'numAffected': 112}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 440, 'numAffected': 330}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 76, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Administration site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 328, 'numAffected': 238}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Administration site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 173, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 94, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Temperature regulation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Vaccination site movement impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Vaccination site scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 573, 'numAffected': 384}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 270, 'numAffected': 201}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 560, 'numAffected': 389}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 122, 'numAffected': 97}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Haematoma muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 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'sourceVocabulary': 'v26.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Leiomyosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Myeloproliferative neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Splenic marginal zone lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 714, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 712, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Confirmed Herpes Zoster (HZ) Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '668', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio (IRR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.46', 'estimateComment': 'IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.', 'groupDescription': 'To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\\<) 5.'}], 'paramType': 'NUMBER', 'timeFrame': 'From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.', 'unitOfMeasure': 'Cases per 1000 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the modified Exposed Set (mES), which excluded participants from the Exposed Set who were not administered 2 doses of the study treatment per protocol, or who developed a confirmed case of HZ prior to 30 days after the second vaccination.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Confirmed HZ Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included PCR and the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.', 'unitOfMeasure': 'Cases per 1000 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any and Grade 3 Solicited Administration Site Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any Erythema, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Pruritus, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pruritus, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Erythema, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Erythema, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '503', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pruritus, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pruritus, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '669', 'groupId': 'OG000'}, {'value': '682', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (\\>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Duration in Days of Solicited Administration Site Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Erythema, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}, {'title': 'Pain, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Pruritus, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Swelling, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.0'}]}]}, {'title': 'Erythema, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}, {'title': 'Pain, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Pruritus, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Swelling, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited administration site event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any, Grade 3 and Related Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any Fatigue, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal symptoms, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal symptoms, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal symptoms, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}, {'value': '697', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Fever, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal symptoms, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal symptoms, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal symptoms, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '321', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '294', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (\\>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (\\>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Duration in Days of Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Fatigue, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Fever, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Gastrointestinal symptoms, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Headache, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Malaise, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Myalgia, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Shivering, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Fatigue, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Fever, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'Gastrointestinal symptoms, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Headache, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}, {'title': 'Malaise, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Myalgia, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}, {'title': 'Shivering, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature \\>=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited systemic event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any Unsolicited AEs, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Unsolicited AEs, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Related Unsolicited AEs, post-vaccination at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any Unsolicited AEs, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Unsolicited AEs, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Related Unsolicited AEs, post-vaccination at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}, {'value': '686', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days after each vaccination (occurring at Day 1 and Month 2)', 'description': "An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom unsolicited AEs data were available for the specified duration after each vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any and Related Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any pIMDs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related pIMDs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom pIMDs data were available for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any and Related SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any and Related pIMDs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'Any pIMDs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related pIMDs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom pIMDs data were available for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs related to investigational vaccine/study participation/GSK concomitant medication/vaccine data were available for the specified duration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '88.5'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '96.9'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 2 and Month 3', 'description': 'Vaccine response for anti-gE antibodies is defined as:\n\n* For initially seronegative participants, anti-gE antibody concentration at post-vaccination \\>= 4-fold the cut-off value for anti-gE \\[97 international units per liter (IU/L)\\].\n* For initially seropositive participants, anti-gE antibody concentration at post-vaccination \\>= 4-fold the pre-vaccination anti-gE antibody concentration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Adapted Per Protocol Set for immunogenicity, which included all evaluable participants from the Exposed Set who met all eligibility criteria, received 2 doses of the HZ/su vaccine/placebo according to their random assignment, did not receive forbidden medications, had no intercurrent medical condition complied with the vaccination and blood sample schedules and for whom results were available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'classes': [{'title': 'At Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2151.30', 'groupId': 'OG000', 'lowerLimit': '2004.22', 'upperLimit': '2309.17'}, {'value': '2087.14', 'groupId': 'OG001', 'lowerLimit': '1942.47', 'upperLimit': '2242.58'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24346.52', 'groupId': 'OG000', 'lowerLimit': '22840.59', 'upperLimit': '25951.74'}, {'value': '1850.11', 'groupId': 'OG001', 'lowerLimit': '1725.86', 'upperLimit': '1983.30'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49175.78', 'groupId': 'OG000', 'lowerLimit': '46500.40', 'upperLimit': '52005.09'}, {'value': '1849.08', 'groupId': 'OG001', 'lowerLimit': '1718.02', 'upperLimit': '1990.13'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1, Month 2 and Month 3', 'description': 'Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.', 'unitOfMeasure': 'IU/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Adapted Per Protocol Set for immunogenicity, which included all evaluable participants from the Exposed Set who met all eligibility criteria, received 2 doses of the HZ/su vaccine/placebo according to their random assignment, did not receive forbidden medications, had no intercurrent medical condition complied with the vaccination and blood sample schedules and for whom results were available for the specified analysis at the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '714'}, {'groupId': 'FG001', 'numSubjects': '712'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '646'}, {'groupId': 'FG001', 'numSubjects': '640'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Non-emergency unblinding/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Migrated/moved from the study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Suspected HZ episode', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 46 centers in 8 countries (Estonia, Finland, Hong Kong, Mexico, Panama, Russian Federation, Spain and United Kingdom).', 'preAssignmentDetails': 'A total of 1430 participants were enrolled into the study, of which 1426 participants received at least 1 dose of study treatment/vaccine (HZ/su or placebo) and were included in the Exposed Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '1426', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '434', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '634', 'groupId': 'BG000'}, {'value': '635', 'groupId': 'BG001'}, {'value': '1269', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-14', 'size': 2165419, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-15T00:30', 'hasProtocol': True}, {'date': '2023-10-06', 'size': 1327759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-15T00:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2019-09-03', 'resultsFirstSubmitDate': '2025-02-15', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Confirmed Herpes Zoster (HZ) Cases', 'timeFrame': 'From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Confirmed HZ Cases', 'timeFrame': 'From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included PCR and the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.'}, {'measure': 'Number of Participants With Any and Grade 3 Solicited Administration Site Events', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (\\>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.'}, {'measure': 'Duration in Days of Solicited Administration Site Events', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.'}, {'measure': 'Number of Participants With Any, Grade 3 and Related Solicited Systemic Events', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (\\>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (\\>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.'}, {'measure': 'Duration in Days of Solicited Systemic Events', 'timeFrame': 'Within 7 days after each vaccination (occurring at Day 1 and Month 2)', 'description': 'Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature \\>=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.'}, {'measure': 'Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within 30 days after each vaccination (occurring at Day 1 and Month 2)', 'description': "An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination."}, {'measure': 'Number of Participants With Any and Related Serious Adverse Events (SAEs)', 'timeFrame': 'From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number of Participants With Any and Related SAEs', 'timeFrame': 'From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number of Participants With Any and Related pIMDs', 'timeFrame': 'From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)', 'description': 'pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.'}, {'measure': 'Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine', 'timeFrame': 'From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)', 'description': 'An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.'}, {'measure': 'Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)', 'timeFrame': 'At Month 2 and Month 3', 'description': 'Vaccine response for anti-gE antibodies is defined as:\n\n* For initially seronegative participants, anti-gE antibody concentration at post-vaccination \\>= 4-fold the cut-off value for anti-gE \\[97 international units per liter (IU/L)\\].\n* For initially seropositive participants, anti-gE antibody concentration at post-vaccination \\>= 4-fold the pre-vaccination anti-gE antibody concentration.'}, {'measure': 'Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA', 'timeFrame': 'At Day 1, Month 2 and Month 3', 'description': 'Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shingles', 'Shingles recurrence', 'HZ', 'Vaccine response rate'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '40780591', 'type': 'BACKGROUND', 'citation': 'Jegede B, Zhou Y, Hawksworth H, Hui DSC, Montenegro Guerra N, Poder A, Ramon JM, Valimaa H, Villanueva-Quintero GD, Mwakingwe-Omari A; Z-062 study group. Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged >/=50 years with a history of herpes zoster: A phase 3, randomized controlled trial. J Infect. 2025 Sep;91(3):106573. doi: 10.1016/j.jinf.2025.106573. Epub 2025 Aug 6.'}, {'pmid': '37781954', 'type': 'DERIVED', 'citation': 'de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.\n* A male or female ≥ 50 YOA at the time of the first vaccination.\n* Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:\n\n * Clinically diagnosed HZ:\n\nOR Laboratory diagnosed HZ: OR\n\n* HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.\n* Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy or post-menopause.\n\n • Female subjects of childbearing potential may be enrolled in the study if the subject:\n* has practiced adequate contraception for 30 days prior to vaccination, and\n* has a negative pregnancy test on the day of vaccination, and\n* has agreed to continue adequate contraception for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.\n* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.\n* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.\n* Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.\n* Chronic antiviral use for HZ prophylaxis.\n* History of \\>1 prior episode of HZ.\n* A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.\n* Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy\n* Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product\n* Previous vaccination against VZV or HZ.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.\n* Acute disease and/or fever at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series."}, 'identificationModule': {'nctId': 'NCT04091451', 'briefTitle': "Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster", 'orgStudyIdInfo': {'id': '204939'}, 'secondaryIdInfos': [{'id': '2016-000744-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HZ/su Group', 'description': 'Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.', 'interventionNames': ['Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)', 'type': 'BIOLOGICAL', 'description': '2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.', 'armGroupLabels': ['HZ/su Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '656043', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '188300', 'city': 'Gatchina', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.57639, 'lon': 30.12833}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.', 'ipdSharing': 'YES', 'description': 'Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\\_GSK\\_Patient\\_Level\\_Data\\_Sharing\\_Final\\_13July2023.pdf', 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}