Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-26 @ 7:06 AM
Study NCT ID:
NCT01199861
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.', 'otherNumAtRisk': 95, 'otherNumAffected': 51, 'seriousNumAtRisk': 95, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.', 'otherNumAtRisk': 43, 'otherNumAffected': 22, 'seriousNumAtRisk': 43, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immune Response 3 Weeks After Seasonal Influenza Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}, {'value': '83.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)', 'description': 'Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:\n\n* Seroconversion: The pre-vaccination antibody titer measurement was \\<1:10 and the post-vaccination measurement is ≥1:40.\n* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set which includes all patients who were randomized and received at least 1 dose of study drug, and for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Immune Response 6 Weeks After Seasonal Influenza Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).', 'description': 'Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:\n\n* Seroconversion: The pre-vaccination antibody titer measurement was \\<1:10 and the post-vaccination measurement is ≥1:40.\n* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Immune Response 3 Weeks After Tetanus Toxoid Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '60.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)', 'description': 'Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:\n\n1. Seroconversion: The pre-vaccination antibody titer measurement was \\<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.\n2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Immune Response 6 Weeks After Tetanus Toxoid Booster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)', 'description': 'Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:\n\n1. Seroconversion: The pre-vaccination antibody titer measurement was \\<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.\n2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'title': 'A/California/7/09(H1N1)', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000'}, {'value': '4.14', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009(H3N2)', 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000'}, {'value': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '1.34', 'groupId': 'OG000'}, {'value': '2.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '41.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '-35.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '44.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).', 'description': 'Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'title': 'A/California/7/09(H1N1)', 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000'}, {'value': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009(H3N2)', 'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000'}, {'value': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000'}, {'value': '2.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '38.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '-28.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Inhibition', 'ciPctValue': '95', 'paramValue': '48.0', 'estimateComment': "One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.", 'groupDescription': 'The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).', 'description': 'Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.', 'unitOfMeasure': 'ratio', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'AE related to study drug', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Adverse events leading to discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until 45 days after the last dose of study drug (130 days).', 'description': 'Relationship to study drug was determined by the investigator (suspected/not suspected).\n\nA serious AE is defined as an event which fulfills one of the following criteria:\n\n* is fatal or life-threatening;\n* results in persistent or significant disability/incapacity;\n* constitutes a congenital anomaly/birth defect;\n* requires inpatient hospitalization or prolongation of existing hospitalization;\n* is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set - all patients who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio to fingolimod 0.5 mg once daily or matching placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '8.37', 'groupId': 'BG000'}, {'value': '39.2', 'spread': '8.67', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '8.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-30', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': '31-40', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': '41-55', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-15', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune Response 3 Weeks After Seasonal Influenza Vaccination', 'timeFrame': 'Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)', 'description': 'Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:\n\n* Seroconversion: The pre-vaccination antibody titer measurement was \\<1:10 and the post-vaccination measurement is ≥1:40.\n* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.'}], 'secondaryOutcomes': [{'measure': 'Immune Response 6 Weeks After Seasonal Influenza Vaccination', 'timeFrame': 'Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).', 'description': 'Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:\n\n* Seroconversion: The pre-vaccination antibody titer measurement was \\<1:10 and the post-vaccination measurement is ≥1:40.\n* Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.'}, {'measure': 'Immune Response 3 Weeks After Tetanus Toxoid Booster', 'timeFrame': 'Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)', 'description': 'Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:\n\n1. Seroconversion: The pre-vaccination antibody titer measurement was \\<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.\n2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.'}, {'measure': 'Immune Response 6 Weeks After Tetanus Toxoid Booster', 'timeFrame': 'Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)', 'description': 'Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:\n\n1. Seroconversion: The pre-vaccination antibody titer measurement was \\<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.\n2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.'}, {'measure': 'Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination', 'timeFrame': 'Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).', 'description': 'Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.'}, {'measure': 'Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination', 'timeFrame': 'Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).', 'description': 'Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose of study drug until 45 days after the last dose of study drug (130 days).', 'description': 'Relationship to study drug was determined by the investigator (suspected/not suspected).\n\nA serious AE is defined as an event which fulfills one of the following criteria:\n\n* is fatal or life-threatening;\n* results in persistent or significant disability/incapacity;\n* constitutes a congenital anomaly/birth defect;\n* requires inpatient hospitalization or prolongation of existing hospitalization;\n* is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above.'}]}, 'conditionsModule': {'keywords': ['Relapsing multiple sclerosis', 'MS', 'Immune response'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have relapsing MS\n* Must have lifetime tetanus vaccination\n* Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection\n\nExclusion Criteria:\n\n* Patients with a type of MS that is not relapsing\n* Patients with history of chronic immune disease\n* Certain cancers\n* Diabetic patients with certain eye disorders\n* Patients who are on certain immunosuppressive medications or heart medications\n* Patients with certain heart conditions\n* Patients with certain lung conditions\n* Patients who have already received the 2010/2011 seasonal influenza vaccine\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01199861', 'briefTitle': 'Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)', 'orgStudyIdInfo': {'id': 'CFTY720D2320'}, 'secondaryIdInfos': [{'id': '2010-019028-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod', 'description': 'Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.', 'interventionNames': ['Drug: Fingolimod', 'Biological: Seasonal influenza vaccine', 'Biological: Tetanus toxoid vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.', 'interventionNames': ['Drug: Placebo', 'Biological: Seasonal influenza vaccine', 'Biological: Tetanus toxoid vaccine']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['FTY720'], 'description': 'Fingolimod 0.5 mg capsules for oral administration.', 'armGroupLabels': ['Fingolimod']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules for oral administration.', 'armGroupLabels': ['Placebo']}, {'name': 'Seasonal influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Agrippal (TM)'], 'description': 'Commercially available injectable influenza vaccine for the 2010/11 influenza season.', 'armGroupLabels': ['Fingolimod', 'Placebo']}, {'name': 'Tetanus toxoid vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Tetanol (TM)'], 'description': 'Commercially available tetanus toxoid vaccine booster injection.', 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'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}