Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-04-16 @ 4:49 PM
Study NCT ID:
NCT01954251
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2013-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
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'}]}}, '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}, 'limitationsAndCaveats': {'description': 'The current data reflect the data reported in the database at the time of the end-of-study analysis. The previous data were based on the primary analysis including a safety analysis up to the data lock point of 7-APR-2015.'}}, 'adverseEventsModule': {'timeFrame': 'Systematically-assessed symptoms: Days 0-7 post each vaccine dose; AEs: Days 0-29 post each vaccine dose; SAEs: from Day 0 to Month 18', 'description': 'There were shifts in the total SAE numbers: GSK1437173A + GSK2321138A Group: 1 subject whose myasthenia gravis (initially not reported as SAE) became an SAE at the final analysis; The Psychotic disorder was renamed Depression; Control Group: initial worsening of hiatal hernia for 1 was later not considered an SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.', 'otherNumAtRisk': 413, 'otherNumAffected': 370, 'seriousNumAtRisk': 413, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.', 'otherNumAtRisk': 415, 'otherNumAffected': 369, 'seriousNumAtRisk': 415, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 344}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 318}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 144}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 135}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 224}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 186}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 92}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 170}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 201}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 201}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 181}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Temperature/(Oral)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 413, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acquired syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Calculus urethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis pharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Occipital neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death (unknown causes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 413, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 415, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Vaccine Response to Anti-gE Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}], 'classes': [{'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post-dose 2 (Month 3)', 'description': 'The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \\< 97 mIU/ml).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Vaccine Response for Anti-gE Humoral Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '97.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At one month post-dose 2 (Month 3)', 'description': 'The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:\n\na 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \\< 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '52151.6', 'groupId': 'OG000', 'lowerLimit': '48356.0', 'upperLimit': '56245.2'}, {'value': '56247.4', 'groupId': 'OG001', 'lowerLimit': '52177.3', 'upperLimit': '60634.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric mean concentration ra', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.20', 'groupDescription': 'Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)', 'description': 'Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'PRIMARY', 'title': 'FLU Haemagglutination Inhibition (HI) Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 HI Day 21', 'categories': [{'measurements': [{'value': '187.5', 'groupId': 'OG000', 'lowerLimit': '166.7', 'upperLimit': '210.8'}, {'value': '194.3', 'groupId': 'OG001', 'lowerLimit': '173.0', 'upperLimit': '218.1'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI Day 21', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000', 'lowerLimit': '58.3', 'upperLimit': '69.7'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '60.3', 'upperLimit': '72.0'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Victoria HI Day 21', 'categories': [{'measurements': [{'value': '170.2', 'groupId': 'OG000', 'lowerLimit': '156.1', 'upperLimit': '185.6'}, {'value': '181.6', 'groupId': 'OG001', 'lowerLimit': '166.7', 'upperLimit': '197.8'}]}]}, {'title': 'Flu B/Massachusetts/2/2012 Yamagata HI Day 21', 'categories': [{'measurements': [{'value': '423.5', 'groupId': 'OG000', 'lowerLimit': '392.0', 'upperLimit': '457.5'}, {'value': '413.9', 'groupId': 'OG001', 'lowerLimit': '383.4', 'upperLimit': '446.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean Titer ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.22', 'groupDescription': 'For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean Titer ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.17', 'groupDescription': 'For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean Titer ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.20', 'groupDescription': 'For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean Titer ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.09', 'groupDescription': 'For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post vaccination', 'description': 'For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.\n\nAdjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With FLU HI Antibody Titers ≥1:10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/California/7/2009 H1N1Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '380', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Victoria Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Victoria Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama Day21 [N=384,394]', 'categories': [{'measurements': [{'value': '384', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 (PRE) and 21 post vaccination', 'description': 'FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/California/7/2009 H1N1 HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Vic HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Vic HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 (PRE) and at Day 21 post vaccination', 'description': 'Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'FLU Haemagglutination Inhibition (HI) Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '33.5'}, {'value': '24.9', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '28.5'}]}]}, {'title': 'Flu A/California/7/2009 H1N1 HI Day 21[N=384,394]', 'categories': [{'measurements': [{'value': '196.2', 'groupId': 'OG000', 'lowerLimit': '172.2', 'upperLimit': '223.5'}, {'value': '193.2', 'groupId': 'OG001', 'lowerLimit': '170.2', 'upperLimit': '219.4'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '21.9'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '21.1'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '72.5'}, {'value': '66.8', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '74.0'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Vic HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '58.1'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '43.7', 'upperLimit': '54'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Vic HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '177.2', 'groupId': 'OG000', 'lowerLimit': '161.6', 'upperLimit': '194.2'}, {'value': '185.2', 'groupId': 'OG001', 'lowerLimit': '168', 'upperLimit': '204.1'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama HI Day 0 [N=386,395]', 'categories': [{'measurements': [{'value': '128.8', 'groupId': 'OG000', 'lowerLimit': '115.7', 'upperLimit': '143.4'}, {'value': '127', 'groupId': 'OG001', 'lowerLimit': '114.9', 'upperLimit': '140.3'}]}]}, {'title': 'Flu B/Massach/2/2012 Yama HI Day 21 [N=384,394]', 'categories': [{'measurements': [{'value': '433.7', 'groupId': 'OG000', 'lowerLimit': '401.3', 'upperLimit': '468.7'}, {'value': '423.3', 'groupId': 'OG001', 'lowerLimit': '388', 'upperLimit': '461.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 (PRE) and Day 21 post vaccination', 'description': 'HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted Subjects in Terms of HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 HI', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Victoria HI', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}]}, {'title': 'Flu B/Massachusetts/2/2012 Yamagata HI', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21 post vaccination', 'description': 'The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Flu A/California/7/2009 H1N1 HI', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.8'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '9'}]}]}, {'title': 'Flu A/Texas/50/2012 H3N2 HI', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.7'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '4.0'}]}]}, {'title': 'Flu B/Brisbane/60/2008 Victoria HI', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3.8'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '4.3'}]}]}, {'title': 'Flu B/Massachusetts/2/2012 Yamagata HI', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3.7'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21 post vaccination', 'description': 'The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Any Pain D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D1 GSK 2321138A [N=410;412]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D2 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A GROUP', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D1 GSK 1437173A [N=410;0]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK 1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group.', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D2 GSK 1437173A [N=403;405]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D3 GSK 2321138A [N=0;0]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data was available for the GSK2321138A vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for the GSK1437173A + GSK2321138A', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain D3 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}]}, {'title': 'G3 Pain D3 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness D3 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'G3 Redness D3 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling D3 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'G3 Swelling D2 GSK 1437173A [N=0;402]', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data was available for the GSK1437173A + GSK2321138A GROUP at Dose 3, since it only received 2 vaccine doses.', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days (Days 0-6) after each vaccine dose', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Any Pain Across Doses', 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain Across Doses', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness Across Doses', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness Across Doses', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling Across Doses', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling Across Doses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days (Days 0-6) 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. Relationship analysis was not performed.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}], 'classes': [{'title': 'Any Arthralgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Arthralgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Related Arthralgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Any Fatigue Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fatigue Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Related Fatigue Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Any Gastrointestinal Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Gastrointestinal Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Related Gastrointestinal Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Related Headache Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Related Myalgia Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature Dose 1 [N=409]', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Any Arthralgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Arthralgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Related Arthralgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'Any Fatigue Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fatigue Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Related Fatigue Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Any Gastrointestinal Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Gastrointestinal Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Gastrointestinal Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Related Headache Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Related Myalgia Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature Dose 2 [N=402]', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days (Days 0-6) after each vaccine dose', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Any Arthralgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Related Arthralgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Any Fatigue, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related Fatigue, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Any Gastrointestinal, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Gastrointestinal, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Headache, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related Myalgia, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Dose 1 [N=411]', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any Arthralgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Related Arthralgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Any Fatigue, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Related Fatigue, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Any Gastrointestinal, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Gastrointestinal, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Related Headache, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Related Myalgia, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Dose 2 [N=405]', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Any Arthralgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Related Arthralgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Any Fatigue, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Fatigue, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Related Fatigue, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}, {'title': 'Any Gastrointestinal, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Related Gastrointestinal, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Any Headache, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Headache, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Related Headache, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Any Myalgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Myalgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Related Myalgia, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Any Shivering, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Shivering, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Related Shivering, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature, Dose 3 [N=402]', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days (Days 0-6) after each vaccine dose', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Any Arthralgia, Across Doses', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Across Doses', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Across Doses', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across Doses', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Across Doses', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Across Doses', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Across Doses', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Across Doses', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Across Doses', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across Doses', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across Doses', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across Doses', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across Doses', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across Doses', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across Doses', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Across Doses', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Across Doses', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Across Doses', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Across Doses', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Across Doses', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Across Doses', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days (Days 0-6) across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 30 days (Days 0-29) after vaccination', '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. Related = AE assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first vaccination up to Month 18 (study end)', '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': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first vaccination up to Month 18 (study end)', 'description': 'pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '415'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}, {'groupId': 'FG001', 'numSubjects': '396'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Out of the 829 subjects enrolled in this trial, 1 subject did not receive vaccination even though subject number had been allocated, hence he/she was excluded from study start.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'BG000'}, {'value': '415', 'groupId': 'BG001'}, {'value': '828', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK1437173A + GSK2321138A Group', 'description': 'The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '8.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '399', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 829}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2015-06-25', 'completionDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-30', 'studyFirstSubmitDate': '2013-09-19', 'dispFirstSubmitQcDate': '2015-06-25', 'resultsFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2013-09-26', 'dispFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-08', 'studyFirstPostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Vaccine Response to Anti-gE Antibodies', 'timeFrame': 'At one month post-dose 2 (Month 3)', 'description': 'The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \\< 97 mIU/ml).'}, {'measure': 'Vaccine Response for Anti-gE Humoral Immunogenicity', 'timeFrame': 'At one month post-dose 2 (Month 3)', 'description': 'The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:\n\na 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off \\< 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%.'}, {'measure': 'Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies', 'timeFrame': 'At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)', 'description': 'Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.'}, {'measure': 'FLU Haemagglutination Inhibition (HI) Antibody Titers', 'timeFrame': 'At Day 21 post vaccination', 'description': 'For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.\n\nAdjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With FLU HI Antibody Titers ≥1:10', 'timeFrame': 'At Day 0 (PRE) and 21 post vaccination', 'description': 'FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.'}, {'measure': 'Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40', 'timeFrame': 'At Day 0 (PRE) and at Day 21 post vaccination', 'description': 'Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).'}, {'measure': 'FLU Haemagglutination Inhibition (HI) Antibody Titers', 'timeFrame': 'At Day 0 (PRE) and Day 21 post vaccination', 'description': 'HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).'}, {'measure': 'Number of Seroconverted Subjects in Terms of HI Antibodies', 'timeFrame': 'At Day 21 post vaccination', 'description': 'The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.'}, {'measure': 'Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer', 'timeFrame': 'At Day 21 post vaccination', 'description': 'The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'Within 7 days (Days 0-6) after each vaccine dose', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.'}, {'measure': 'Number of Subjects With Solicited Local Symptoms', 'timeFrame': 'Within 7 days (Days 0-6) 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. Relationship analysis was not performed.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'Within 7 days (Days 0-6) after each vaccine dose', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Solicited General Symptoms', 'timeFrame': 'Within 7 days (Days 0-6) across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During 30 days (Days 0-29) after vaccination', '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. Related = AE assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From first vaccination up to Month 18 (study end)', '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 Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'From first vaccination up to Month 18 (study end)', 'description': 'pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}]}, 'conditionsModule': {'keywords': ['FLU-D-QIV', 'Adults', 'Safety', 'Immunogenicity', 'co-administration', 'Herpes zoster'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'availIpds': [{'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '117036', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '29029224', 'type': 'DERIVED', 'citation': 'Schwarz TF, Aggarwal N, Moeckesch B, Schenkenberger I, Claeys C, Douha M, Godeaux O, Grupping K, Heineman TC, Fauqued ML, Oostvogels L, Van den Steen P, Lal H. Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2017 Dec 12;216(11):1352-1361. doi: 10.1093/infdis/jix481.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).\n* A male or female aged 50 years or older, at the time of the first vaccination with the study vaccine(s).\n* Written informed consent obtained from the subject.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n\n * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to vaccination, and\n * has a negative pregnancy test on the day of vaccination, and\n * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of \\< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.\n* Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) (HZ/su and/or FLU-D-QIV vaccines) and ending 30 days after the last dose of HZ/su vaccine.\n* Administration of an influenza vaccine during the six months preceding entry into the study or planned administration up to the last blood sampling with the exception of the FLU-D-QIV vaccine given during this study.\n* Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).\n* Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine.\n* History of HZ.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.\n* History of Guillain Barré syndrome.\n* Hypersensitivity to latex.\n* Acute disease and/or fever at the time of enrolment.\n\n * Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.\n * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.\n* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.\n* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.\n* Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.'}, 'identificationModule': {'nctId': 'NCT01954251', 'briefTitle': "Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older", 'orgStudyIdInfo': {'id': '117036'}, 'secondaryIdInfos': [{'id': '2013-000372-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Co-Ad Group', 'description': 'The subjects assigned to the Co-Ad group will receive one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.', 'interventionNames': ['Biological: Herpes Zoster vaccine GSK 1437173A', "Biological: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The subjects assigned to the Control group will receive all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.', 'interventionNames': ['Biological: Herpes Zoster vaccine GSK 1437173A', "Biological: GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A"]}], 'interventions': [{'name': 'Herpes Zoster vaccine GSK 1437173A', 'type': 'BIOLOGICAL', 'description': '2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.', 'armGroupLabels': ['Co-Ad Group', 'Control Group']}, {'name': "GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A", 'type': 'BIOLOGICAL', 'otherNames': ['Influsplit™ Tetra (Germany)', 'Fluarix™ Quadrivalent (United States)'], 'description': '2 doses administered intramuscularly (IM) in the deltoid region of the dominant arm.', 'armGroupLabels': ['Co-Ad Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '15106', 'city': 'Carnegie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.40868, 'lon': -80.08339}}, {'zip': '16508', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'M9W 4L6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '69469', 'city': 'Weinheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'zip': '97070', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '65439', 'city': 'Flörsheim', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.01311, 'lon': 8.42779}}, {'zip': '45355', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '47574', 'city': 'Goch', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.67873, 'lon': 6.15895}}, {'zip': '01744', 'city': 'Dippoldiswalde', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.89621, 'lon': 13.66905}}, {'zip': '09599', 'city': 'Freiberg', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.91089, 'lon': 13.33881}}, {'zip': '01705', 'city': 'Freital', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.00166, 'lon': 13.6488}}, {'zip': '23554', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10717', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10787', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13347', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}