Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT00920218
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2009-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 27, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 29, 'seriousNumAtRisk': 31, 'deathsNumAffected': 2, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 21, 'seriousNumAtRisk': 30, 'deathsNumAffected': 3, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 39, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 44, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 23, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 26, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 46, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 32, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 41, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 73, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 53, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 49, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-days (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper 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{'title': 'Related Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any Gastr. sympt., Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 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{'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Gastr. sympt., Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Related Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Related Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-days (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[including nausea, vomiting, diarrhoea and abdominal pain\\], temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'GSK 1437173A 2D Group', 'description': 'Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.'}, {'id': 'OG003', 'title': 'Placebo 1D Group', 'description': 'Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.'}, {'id': 'OG004', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day (Days 0-29) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'GSK 1437173A 2D Group', 'description': 'Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.'}, {'id': 'OG003', 'title': 'Placebo 1D Group', 'description': 'Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.'}, {'id': 'OG004', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Any time during the study up to Day 29 after the last vaccination', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 15)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 30-day (Days 0-29) post last vaccination period', 'description': 'Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 to Month 15)', 'description': 'Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'ALT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'BAS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CAL', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CREA', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'FIBR', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'HGB', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HCT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'LYM', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'MON', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PLAT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PTT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'RBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TP', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 0', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'ALT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'BAS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CAL', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CREA', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'FIBR', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'HGB', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HCT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'LYM', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'MON', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PLAT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PTT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'RBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TP', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 1', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'ALT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'BAS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CAL', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'CREA', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'FIBR', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'HGB', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HCT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'LYM', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'MON', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PLAT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PTT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'RBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TP', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 2', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'ALT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'BAS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'CAL', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'CREA', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'FIBR', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'HGB', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HCT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'LYM', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'MON', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PLAT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'PTT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'RBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TP', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'WBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 3', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'ALT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AST', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'BAS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CAL', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CREA', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'EOS', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'FIBR', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HGB', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HCT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'LDH', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'LYM', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'MON', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PLAT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'PTT', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'RBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TP', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC', 'categories': [{'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 4', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '11963.56', 'spread': '11655.09', 'groupId': 'OG000'}, {'value': '8114.83', 'spread': '9957.55', 'groupId': 'OG001'}, {'value': '6974.97', 'spread': '10437.53', 'groupId': 'OG002'}, {'value': '96.15', 'spread': '108.08', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Fold increase over Control', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '76.16', 'paramValue': '32.31', 'ciLowerLimit': '20.65', 'ciUpperLimit': '50.54', 'groupDescription': 'The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\\<) 1.', 'statisticalMethod': 'Dunnett for multiple comparisons', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\\>) 2.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Fold increase over Control', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '76.16', 'paramValue': '9.51', 'ciLowerLimit': '6.07', 'ciUpperLimit': '14.9', 'groupDescription': 'The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \\< 2.', 'statisticalMethod': 'Dunnett for multiple comparisons', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\\>) 2.'}], 'paramType': 'MEAN', 'timeFrame': 'At Month 4', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).', 'unitOfMeasure': 'gE-specific CD4+ T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '29192.9', 'groupId': 'OG000', 'lowerLimit': '11004.7', 'upperLimit': '77442.1'}, {'value': '22503.0', 'groupId': 'OG001', 'lowerLimit': '8432.7', 'upperLimit': '60050.2'}, {'value': '11064.6', 'groupId': 'OG002', 'lowerLimit': '4361.2', 'upperLimit': '28071.8'}, {'value': '406.0', 'groupId': 'OG003', 'lowerLimit': '244.2', 'upperLimit': '674.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Fold increase over Control', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '76.16', 'paramValue': '74.41', 'ciLowerLimit': '33.12', 'ciUpperLimit': '167.17', 'groupDescription': 'The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \\< 1.', 'statisticalMethod': 'Dunnett for multiple comparisons', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\\>) 3.'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Fold increase over Control', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '76.16', 'paramValue': '42.20', 'ciLowerLimit': '20.20', 'ciUpperLimit': '88.13', 'groupDescription': 'The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \\< 1.', 'statisticalMethod': 'Dunnett for multiple comparisons', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\\>) 3.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 4', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Anti-gE Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '131471.10', 'spread': '169644.69', 'groupId': 'OG000'}, {'value': '102106.14', 'spread': '116349.94', 'groupId': 'OG001'}, {'value': '63768.06', 'spread': '100839.95', 'groupId': 'OG002'}, {'value': '840.46', 'spread': '1119.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Month 4', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '356.11', 'spread': '519.79', 'groupId': 'OG000'}, {'value': '449.31', 'spread': '637.09', 'groupId': 'OG001'}, {'value': '343.90', 'spread': '381.20', 'groupId': 'OG002'}, {'value': '273.91', 'spread': '280.07', 'groupId': 'OG003'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '636.10', 'spread': '886.14', 'groupId': 'OG000'}, {'value': '1205.59', 'spread': '2680.05', 'groupId': 'OG001'}, {'value': '303.70', 'spread': '383.32', 'groupId': 'OG002'}, {'value': '486.97', 'spread': '652.18', 'groupId': 'OG003'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3818.03', 'spread': '3773.74', 'groupId': 'OG000'}, {'value': '4466.98', 'spread': '7100.05', 'groupId': 'OG001'}, {'value': '928.35', 'spread': '1773.80', 'groupId': 'OG002'}, {'value': '249.91', 'spread': '243.82', 'groupId': 'OG003'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3488.70', 'spread': '4130.59', 'groupId': 'OG000'}, {'value': '3628.20', 'spread': '6682.51', 'groupId': 'OG001'}, {'value': '887.86', 'spread': '1244.78', 'groupId': 'OG002'}, {'value': '511.33', 'spread': '909.03', 'groupId': 'OG003'}]}]}, {'title': 'At Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5359.40', 'spread': '6486.90', 'groupId': 'OG000'}, {'value': '4243.82', 'spread': '6216.73', 'groupId': 'OG001'}, {'value': '4481.70', 'spread': '6761.94', 'groupId': 'OG002'}, {'value': '279.35', 'spread': '246.06', 'groupId': 'OG003'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3104.65', 'spread': '3543.66', 'groupId': 'OG000'}, {'value': '3298.68', 'spread': '4326.74', 'groupId': 'OG001'}, {'value': '2669.66', 'spread': '3121.01', 'groupId': 'OG002'}, {'value': '320.39', 'spread': '337.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).', 'unitOfMeasure': 'VZV specific CD4+ T-cells/million Tcells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116.53', 'spread': '180.53', 'groupId': 'OG000'}, {'value': '145.97', 'spread': '217.01', 'groupId': 'OG001'}, {'value': '83.15', 'spread': '90.39', 'groupId': 'OG002'}, {'value': '97.48', 'spread': '148.32', 'groupId': 'OG003'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '856.69', 'spread': '1551.94', 'groupId': 'OG000'}, {'value': '1376.95', 'spread': '3358.49', 'groupId': 'OG001'}, {'value': '91.84', 'spread': '118.22', 'groupId': 'OG002'}, {'value': '133.85', 'spread': '204.90', 'groupId': 'OG003'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8830.03', 'spread': '9745.11', 'groupId': 'OG000'}, {'value': '9128.95', 'spread': '12539.86', 'groupId': 'OG001'}, {'value': '1528.60', 'spread': '3204.39', 'groupId': 'OG002'}, {'value': '124.53', 'spread': '160.24', 'groupId': 'OG003'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7111.22', 'spread': '7755.09', 'groupId': 'OG000'}, {'value': '8415.89', 'spread': '12235.84', 'groupId': 'OG001'}, {'value': '827.83', 'spread': '1508.97', 'groupId': 'OG002'}, {'value': '158.13', 'spread': '180.84', 'groupId': 'OG003'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6865.36', 'spread': '6557.75', 'groupId': 'OG000'}, {'value': '5900.24', 'spread': '7728.98', 'groupId': 'OG001'}, {'value': '3859.68', 'spread': '4771.08', 'groupId': 'OG002'}, {'value': '71.03', 'spread': '80.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).', 'unitOfMeasure': 'gE-specific CD4+ T-cells/million T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '570.1', 'groupId': 'OG000', 'lowerLimit': '393.1', 'upperLimit': '826.8'}, {'value': '755.1', 'groupId': 'OG001', 'lowerLimit': '479.2', 'upperLimit': '1189.9'}, {'value': '639.9', 'groupId': 'OG002', 'lowerLimit': '397.5', 'upperLimit': '1030.1'}, {'value': '659.2', 'groupId': 'OG003', 'lowerLimit': '496.9', 'upperLimit': '874.4'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '922.2', 'groupId': 'OG000', 'lowerLimit': '575.6', 'upperLimit': '1477.4'}, {'value': '1017.3', 'groupId': 'OG001', 'lowerLimit': '609.6', 'upperLimit': '1697.7'}, {'value': '562.4', 'groupId': 'OG002', 'lowerLimit': '346.9', 'upperLimit': '912.0'}, {'value': '729.4', 'groupId': 'OG003', 'lowerLimit': '512.0', 'upperLimit': '1039.2'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4268.5', 'groupId': 'OG000', 'lowerLimit': '2075.7', 'upperLimit': '8777.9'}, {'value': '4541.3', 'groupId': 'OG001', 'lowerLimit': '2506.4', 'upperLimit': '8228.2'}, {'value': '702.4', 'groupId': 'OG002', 'lowerLimit': '398.5', 'upperLimit': '1238.0'}, {'value': '523.5', 'groupId': 'OG003', 'lowerLimit': '351.8', 'upperLimit': '779.2'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3940.7', 'groupId': 'OG000', 'lowerLimit': '1819.0', 'upperLimit': '8537.5'}, {'value': '4598.3', 'groupId': 'OG001', 'lowerLimit': '2292.6', 'upperLimit': '9222.8'}, {'value': '558.2', 'groupId': 'OG002', 'lowerLimit': '302.3', 'upperLimit': '1030.6'}, {'value': '632.7', 'groupId': 'OG003', 'lowerLimit': '374.5', 'upperLimit': '1068.8'}]}]}, {'title': 'At Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8484.1', 'groupId': 'OG000', 'lowerLimit': '4190.6', 'upperLimit': '17176.4'}, {'value': '6223.4', 'groupId': 'OG001', 'lowerLimit': '2893.7', 'upperLimit': '13384.5'}, {'value': '3196.6', 'groupId': 'OG002', 'lowerLimit': '1532.2', 'upperLimit': '6668.9'}, {'value': '351.9', 'groupId': 'OG003', 'lowerLimit': '207.9', 'upperLimit': '595.7'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1946.5', 'groupId': 'OG000', 'lowerLimit': '1013.4', 'upperLimit': '3738.6'}, {'value': '2598.2', 'groupId': 'OG001', 'lowerLimit': '1327.4', 'upperLimit': '5085.6'}, {'value': '930.3', 'groupId': 'OG002', 'lowerLimit': '390.1', 'upperLimit': '2218.6'}, {'value': '339.4', 'groupId': 'OG003', 'lowerLimit': '159.0', 'upperLimit': '724.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'VZV-specific Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '968.22', 'spread': '1466.46', 'groupId': 'OG000'}, {'value': '1340.29', 'spread': '1685.09', 'groupId': 'OG001'}, {'value': '1304.22', 'spread': '1866.32', 'groupId': 'OG002'}, {'value': '843.07', 'spread': '616.78', 'groupId': 'OG003'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1881.91', 'spread': '2742.85', 'groupId': 'OG000'}, {'value': '1957.16', 'spread': '2438.00', 'groupId': 'OG001'}, {'value': '1089.57', 'spread': '1586.68', 'groupId': 'OG002'}, {'value': '1158.99', 'spread': '1407.26', 'groupId': 'OG003'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15155.95', 'spread': '22198.03', 'groupId': 'OG000'}, {'value': '10934.78', 'spread': '13735.35', 'groupId': 'OG001'}, {'value': '1506.49', 'spread': '2120.19', 'groupId': 'OG002'}, {'value': '911.09', 'spread': '1211.24', 'groupId': 'OG003'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13342.90', 'spread': '19278.57', 'groupId': 'OG000'}, {'value': '12602.99', 'spread': '18030.89', 'groupId': 'OG001'}, {'value': '1227.40', 'spread': '1794.62', 'groupId': 'OG002'}, {'value': '2902.89', 'spread': '10461.29', 'groupId': 'OG003'}]}]}, {'title': 'At Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23858.74', 'spread': '31173.45', 'groupId': 'OG000'}, {'value': '16752.32', 'spread': '17738.95', 'groupId': 'OG001'}, {'value': '10744.24', 'spread': '17397.97', 'groupId': 'OG002'}, {'value': '753.59', 'spread': '1155.17', 'groupId': 'OG003'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4694.74', 'spread': '5945.23', 'groupId': 'OG000'}, {'value': '5482.75', 'spread': '5769.88', 'groupId': 'OG001'}, {'value': '2956.21', 'spread': '4515.53', 'groupId': 'OG002'}, {'value': '835.21', 'spread': '947.65', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Anti-gE Geometric Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '531.2', 'groupId': 'OG000', 'lowerLimit': '402.6', 'upperLimit': '700.8'}, {'value': '536.2', 'groupId': 'OG001', 'lowerLimit': '304.0', 'upperLimit': '945.7'}, {'value': '448.0', 'groupId': 'OG002', 'lowerLimit': '289.7', 'upperLimit': '692.8'}, {'value': '659.9', 'groupId': 'OG003', 'lowerLimit': '470.5', 'upperLimit': '925.4'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1489.7', 'groupId': 'OG000', 'lowerLimit': '847.3', 'upperLimit': '2619.0'}, {'value': '1288.1', 'groupId': 'OG001', 'lowerLimit': '684.9', 'upperLimit': '2422.5'}, {'value': '376.1', 'groupId': 'OG002', 'lowerLimit': '239.7', 'upperLimit': '590.1'}, {'value': '619.3', 'groupId': 'OG003', 'lowerLimit': '424.2', 'upperLimit': '904.0'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11963.0', 'groupId': 'OG000', 'lowerLimit': '4739.4', 'upperLimit': '30196.6'}, {'value': '11628.8', 'groupId': 'OG001', 'lowerLimit': '5196.6', 'upperLimit': '26022.8'}, {'value': '1047.8', 'groupId': 'OG002', 'lowerLimit': '564.8', 'upperLimit': '1943.9'}, {'value': '520.2', 'groupId': 'OG003', 'lowerLimit': '349.3', 'upperLimit': '774.8'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13412.9', 'groupId': 'OG000', 'lowerLimit': '4967.1', 'upperLimit': '36219.7'}, {'value': '13385.4', 'groupId': 'OG001', 'lowerLimit': '5506.5', 'upperLimit': '32537.7'}, {'value': '972.6', 'groupId': 'OG002', 'lowerLimit': '520.6', 'upperLimit': '1817.2'}, {'value': '585.2', 'groupId': 'OG003', 'lowerLimit': '310.0', 'upperLimit': '1104.9'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8052.7', 'groupId': 'OG000', 'lowerLimit': '3333.4', 'upperLimit': '19453.7'}, {'value': '9165.5', 'groupId': 'OG001', 'lowerLimit': '3796.0', 'upperLimit': '22130.1'}, {'value': '2968.0', 'groupId': 'OG002', 'lowerLimit': '1184.7', 'upperLimit': '7436.1'}, {'value': '362.3', 'groupId': 'OG003', 'lowerLimit': '170.7', 'upperLimit': '768.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Anti-gE Mean Antibody Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'title': 'At Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '683.78', 'spread': '501.88', 'groupId': 'OG000'}, {'value': '1366.94', 'spread': '2510.90', 'groupId': 'OG001'}, {'value': '763.58', 'spread': '818.71', 'groupId': 'OG002'}, {'value': '1025.07', 'spread': '1177.35', 'groupId': 'OG003'}]}]}, {'title': 'At Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4435.62', 'spread': '7776.94', 'groupId': 'OG000'}, {'value': '3812.19', 'spread': '7197.49', 'groupId': 'OG001'}, {'value': '675.39', 'spread': '776.37', 'groupId': 'OG002'}, {'value': '1016.00', 'spread': '1159.33', 'groupId': 'OG003'}]}]}, {'title': 'At Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76302.68', 'spread': '118526.31', 'groupId': 'OG000'}, {'value': '47344.49', 'spread': '78643.10', 'groupId': 'OG001'}, {'value': '2951.78', 'spread': '4785.22', 'groupId': 'OG002'}, {'value': '927.04', 'spread': '1221.66', 'groupId': 'OG003'}]}]}, {'title': 'At Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88592.39', 'spread': '133279.24', 'groupId': 'OG000'}, {'value': '62174.90', 'spread': '94796.54', 'groupId': 'OG001'}, {'value': '2739.11', 'spread': '4458.45', 'groupId': 'OG002'}, {'value': '8908.62', 'spread': '42086.07', 'groupId': 'OG003'}]}]}, {'title': 'At Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42128.75', 'spread': '66869.22', 'groupId': 'OG000'}, {'value': '30938.91', 'spread': '45130.79', 'groupId': 'OG001'}, {'value': '16564.63', 'spread': '30523.28', 'groupId': 'OG002'}, {'value': '1091.74', 'spread': '1585.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Confirmed Herpes Zoster (HZ) Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'OG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 to Month 15)', 'description': "A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'he analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'FG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'FG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'FG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Transplant failed/malignancy recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Serological evidence of prior Varicella-Zoster Virus infection for those born in 1980 or later and for those born outside the US before 1980 in a tropical or sub-tropical region was required. All subjects were to have undergone autologous hematopoietic stem cell transplantation (HCT) within the past 50-70 days; and had no additional HCTs planned.', 'preAssignmentDetails': 'Out of the 121 subjects enrolled into this study, 1 subject was eliminated due to not receiving study vaccination and hence only 120 subjects started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'BG001', 'title': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'BG002', 'title': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'BG003', 'title': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '57.3', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '56.1', 'spread': '10.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'African Heritage/African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian-Central/South Asian Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian-East Asian Heritage', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian-Japanese Heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White-Arabic/North African Heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White-Caucasian/European Heritage', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2011-06-01', 'completionDateStruct': {'date': '2012-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2009-06-12', 'dispFirstSubmitQcDate': '2011-06-01', 'resultsFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2009-06-12', 'dispFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-10', 'studyFirstPostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-days (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-days (Days 0-6) post-vaccination period following each dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[including nausea, vomiting, diarrhoea and abdominal pain\\], temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (\\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day (Days 0-29) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Any time during the study up to Day 29 after the last vaccination', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'During the entire study period (from Day 0 up to Month 15)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders', 'timeFrame': 'Within the 30-day (Days 0-29) post last vaccination period', 'description': 'Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.'}, {'measure': 'Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders', 'timeFrame': 'During the entire study period (from Day 0 to Month 15)', 'description': 'Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.'}, {'measure': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'timeFrame': 'At Month 0', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).'}, {'measure': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'timeFrame': 'At Month 1', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).'}, {'measure': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'timeFrame': 'At Month 2', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).'}, {'measure': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'timeFrame': 'At Month 3', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).'}, {'measure': 'Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges', 'timeFrame': 'At Month 4', 'description': 'Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).'}, {'measure': 'Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines', 'timeFrame': 'At Month 4', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).'}, {'measure': 'Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations', 'timeFrame': 'At Month 4', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-gE Mean Antibody Concentrations', 'timeFrame': 'At Month 4', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).'}], 'secondaryOutcomes': [{'measure': 'Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).'}, {'measure': 'Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \\[IFN-γ\\], Interleukin 2 \\[IL-2\\], Tumour Necrosis Factor alpha \\[TNF-α\\] and/or CD40 Ligand \\[CD40L\\] as determined by in vitro intracellular cytokine staining (ICS).'}, {'measure': 'Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'VZV-specific Mean Antibody Concentrations', 'timeFrame': 'At Months 0, 1, 2, 3, 4 and 15', 'description': 'Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-gE Geometric Mean Antibody Concentrations', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Anti-gE Mean Antibody Concentrations', 'timeFrame': 'At Months 0, 1, 2, 3 and 15', 'description': 'Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Confirmed Herpes Zoster (HZ) Cases', 'timeFrame': 'During the entire study period (from Day 0 to Month 15)', 'description': "A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study."}]}, 'conditionsModule': {'keywords': ['Vaccine', 'Safety', 'Herpes Zoster', 'Immunogenicity', 'Stem cell transplantation'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '25237196', 'type': 'DERIVED', 'citation': 'Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, Mossad SB, Andreadis C, Young JA, Buadi FK, El Idrissi M, Heineman TC, Berkowitz EM. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921-9. doi: 10.1182/blood-2014-04-573048. Epub 2014 Sep 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.", 'detailedDescription': 'The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;\n* Male and female subjects at least 18 years old at the time of vaccination;\n* Serological evidence of prior VZV infection for all subjects born in 1980 or later and for subjects born outside the US before 1980 in a tropical or sub-tropical region. No testing for serological evidence of prior VZV infection is required for US subjects born before 1980;\n* Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and there are no plans for additional HCTs\n* Written informed consent obtained from the subject;\n* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;\n* Administration or planned administration of a vaccine that is not part of the study protocol since transplantation. However licensed non-replicating vaccines (i.e. inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;\n* Administration of immunoglobulins since transplantation;\n* Previous vaccination against varicella or HZ;\n* History of HZ within the previous 12 months;\n* Known exposure to VZV since transplantation;\n* Evidence of active infection at the time of enrollment including a temperature of ≥ 37.5° C or any serious HCT-related complication;\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;\n* Hypersensitivity or intolerance to acyclovir or valacyclovir;\n* Pregnant or lactating female.'}, 'identificationModule': {'nctId': 'NCT00920218', 'briefTitle': "Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A", 'orgStudyIdInfo': {'id': '110258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'interventionNames': ['Biological: Herpes Zoster Vaccine 1437173A']}, {'type': 'EXPERIMENTAL', 'label': 'GSK 1437173A F2 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'interventionNames': ['Biological: Herpes Zoster Vaccine 1437173A']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-GSK 1437173A F1 Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'interventionNames': ['Biological: Herpes Zoster Vaccine 1437173A', 'Biological: Placebo vaccine (saline)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.', 'interventionNames': ['Biological: Placebo vaccine (saline)']}], 'interventions': [{'name': 'Herpes Zoster Vaccine 1437173A', 'type': 'BIOLOGICAL', 'description': 'Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.', 'armGroupLabels': ['GSK 1437173A F1 Group', 'GSK 1437173A F2 Group', 'Placebo-GSK 1437173A F1 Group']}, {'name': 'Placebo vaccine (saline)', 'type': 'BIOLOGICAL', 'description': '1 or 3 doses of Placebo (saline) injected intramuscularly.', 'armGroupLabels': ['Placebo Group', 'Placebo-GSK 1437173A F1 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneota', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.55885, 'lon': -95.98559}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}