Viewing Study NCT00596102

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Ignite Creation Date: 2025-12-25 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
Study NCT ID: NCT00596102
Status: COMPLETED
Last Update Posted: 2014-07-30
First Post: 2008-01-04
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@valneva.com', 'phone': '+43 1 20620', 'title': 'Katrin Dubischar-Kastner', 'phoneExt': '0', 'organization': 'Valneva Austria GmbH'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60', 'description': 'group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")', 'eventGroups': [{'id': 'EG000', 'title': 'IC51 Month 6', 'description': 'no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6', 'otherNumAtRisk': 2283, 'otherNumAffected': 78, 'seriousNumAtRisk': 2283, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'JE-VAX', 'description': 'no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6', 'otherNumAtRisk': 338, 'otherNumAffected': 16, 'seriousNumAtRisk': 338, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6', 'otherNumAtRisk': 637, 'otherNumAffected': 31, 'seriousNumAtRisk': 637, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'IC51 Month 60', 'description': 'no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60', 'otherNumAtRisk': 102, 'otherNumAffected': 54, 'seriousNumAtRisk': 102, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 19}], 'organSystem': 'Infections and infestations'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Acute Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Infections and infestations'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Dental Implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Appendix Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Appendiceal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Joint Ligament Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Tibia Fructure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Synovial Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Adenocarinoma Pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Lung Adenocarcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Central Nervous System Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ectopic Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Mediastinal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Meniscus Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Coronary Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Abscess Soft Tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Smear Cervix Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Shoulder Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Toe Deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Post Herpetic Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Urethral Stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Nasal Septum Deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Blood Donor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 637, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Social circumstances'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IC51', 'description': 'no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '75.7', 'upperLimit': '86.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months after the first vaccination', 'description': 'first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)', 'timeFrame': '6, 12, 36, 48 and 60 months after 1st vaccination', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers', 'timeFrame': '6, 12, 36, 48 and 60 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'timeFrame': '6, 12, 24, 36, 48 and 60 months after 1st vaccination', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IC51', 'description': 'no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302'}, {'id': 'FG001', 'title': 'JE-VAX', 'description': 'no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302'}], 'periods': [{'title': 'Up to Month 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2283'}, {'groupId': 'FG001', 'numSubjects': '338'}, {'groupId': 'FG002', 'numSubjects': '637'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2283'}, {'groupId': 'FG001', 'numSubjects': '338'}, {'groupId': 'FG002', 'numSubjects': '637'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Up to Month 60', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2283'}, {'groupId': 'FG001', 'numSubjects': '338'}, {'groupId': 'FG002', 'numSubjects': '637'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'long-term safety follow-up beyond Month 6 for a sub-set of subjects in "IC51" group only', 'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2181'}, {'groupId': 'FG001', 'numSubjects': '338'}, {'groupId': 'FG002', 'numSubjects': '637'}]}]}], 'recruitmentDetails': 'study participants were recruited from 44 study centers previously participating in study IC51-301 and IC51-302'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2283', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '637', 'groupId': 'BG002'}, {'value': '3258', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IC51', 'description': 'no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302'}, {'id': 'BG001', 'title': 'JE-VAX', 'description': 'no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '33.5', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '35.6', 'spread': '13.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1274', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}, {'value': '1840', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1009', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}, {'value': '1418', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '2076', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '574', 'groupId': 'BG002'}, {'value': '2938', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-27', 'studyFirstSubmitDate': '2008-01-04', 'resultsFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-27', 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)', 'timeFrame': '24 months after the first vaccination', 'description': 'first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)', 'timeFrame': '6, 12, 36, 48 and 60 months after 1st vaccination'}, {'measure': 'Geometric Mean Titers', 'timeFrame': '6, 12, 36, 48 and 60 months'}, {'measure': 'Adverse Events', 'timeFrame': '6, 12, 24, 36, 48 and 60 months after 1st vaccination'}]}, 'conditionsModule': {'conditions': ['Japanese Encephalitis']}, 'referencesModule': {'references': [{'pmid': '30962094', 'type': 'DERIVED', 'citation': 'Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085).\n\nOnly \\~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects at least 18 years of age\n* Written informed consent obtained prior to study entry\n* Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent and to abide the requirements of the study'}, 'identificationModule': {'nctId': 'NCT00596102', 'briefTitle': 'Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51', 'organization': {'class': 'INDUSTRY', 'fullName': 'Valneva Austria GmbH'}, 'officialTitle': 'Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51. An Uncontrolled Phase 3 Follow-up Study', 'orgStudyIdInfo': {'id': 'IC51-303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Japanese Encephalitis purified inactivated vaccine', 'type': 'BIOLOGICAL', 'description': 'Japanese Encephalitis purified inactivated vaccine'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Evelyn Hatzenbichler, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Valneva Austria GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valneva Austria GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}