Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-31 @ 1:23 AM
Study NCT ID:
NCT05028634
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2021-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).', 'description': 'As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups.\n\ni. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.', 'eventGroups': [{'id': 'EG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 7, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '53.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is \\>0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is\\>2.7 IU/mL, at least a 2-fold increase in titer.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \\>= 0.1 International Units per milliliter (IU/mL).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Serological response to PPSV23 was defined as the percentage of participants with a ≥2-fold increase in anti-pneumococcal polysaccharide vaccine titer in \\>5 of the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '71.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Serological protection against PPSV23 was defined as the percentage of participants with Anti-pneumococcal polysaccharide IgG concentration \\>= 1.3 μg/mL in the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F associated with increased risk of invasive and/or severe disease, including death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate or Severe AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 28', 'description': 'Adverse events include events with onset date on or after the study medication first dose date until end of study visit after the vaccine administration. Serious AEs was defined as is any AE occurring at any dose of vaccination from Day 1 to the end of the study that results in death, Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of death from the AE), Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Blood Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Alanine Transaminase (ALT) OR Aspartate aminotransferase (AST) > 1X Upper Limit of Normal (ULN)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'ALT or AST > 2XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST > 5XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT OR AST > 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Gamma-glutamyl transferase (GGT) OR Alkaline Phosphatase (ALP) > 1XULN', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'GGT OR ALP > 2.5XULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT OR ALP > 5XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT OR ALP > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 1XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 1.5XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 3XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL BILIRUBIN > 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 28', 'description': 'Blood samples were collected to assess laboratory parameters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Blood Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'ABSOLUTE LYMPHOCYTE COUNT (ALC) < 0.2 (x10E9/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ABSOLUTE NEUTROPHIL COUNT (ANC) < 0.5 (x10E9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ABSOLUTE NEUTROPHIL COUNT (ANC) < 1 (x10E9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TOTAL WBC > 20 (x10E9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 28', 'description': 'Blood samples were collected to assess laboratory parameters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.637', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.315', 'groupId': 'OG001'}]}]}, {'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.0881', 'groupId': 'OG000'}, {'value': '-0.015', 'spread': '0.0888', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0572', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.0549', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.011', 'spread': '0.2197', 'groupId': 'OG000'}, {'value': '-0.041', 'spread': '0.1640', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.044', 'spread': '1.1424', 'groupId': 'OG000'}, {'value': '0.165', 'spread': '1.1542', 'groupId': 'OG001'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.845', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.946', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '9.77', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Chemistry Parameters - Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '14.48', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '8.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '8.88', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '5.08', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '5.64', 'groupId': 'OG001'}]}]}, {'title': 'Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '23.09', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '8.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.265', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '1.271', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '1.298', 'groupId': 'OG001'}]}]}, {'title': 'Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.013', 'spread': '0.0320', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.0253', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.038', 'spread': '0.2872', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.1531', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.046', 'spread': '0.1806', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.3580', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.1734', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.1506', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.480', 'spread': '1.1208', 'groupId': 'OG000'}, {'value': '0.218', 'spread': '1.2622', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '37.08', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '36.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Basophils/Leukocytes', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.528', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.442', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils/Leukocytes', 'categories': [{'measurements': [{'value': '0.05', 'spread': '3.919', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '1.950', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/Leukocytes', 'categories': [{'measurements': [{'value': '0.17', 'spread': '3.675', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '6.883', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes/Leukocytes', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '3.135', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '2.192', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/Leukocytes', 'categories': [{'measurements': [{'value': '1.09', 'spread': '6.750', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '7.177', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes Mean Corpuscular HGB Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '9.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'fL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.', 'unitOfMeasure': 'pg/cell', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids. Participants with data available at the specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Hematology Parameters - Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'OG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.0226', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.0270', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters. Participants with baseline and post-baseline data available at the specified timepoint are included in the analysis.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'FG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups.\n\ni. Ozanimod treatment group ii. Non-Ozanimod treatment group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1.'}, {'id': 'BG001', 'title': 'Non-Ozanimod', 'description': 'Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '9.03', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '6.83', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '8.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-29', 'size': 4616914, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-05T02:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2021-08-25', 'resultsFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-27', 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen', 'timeFrame': 'Day 28', 'description': 'Serologic response to tetanus toxoid criteria are as follows - if pre vaccination antibody titer is ≤0.10 IU/mL, post-vaccination level ≥0.40 IU/mL; if pre-vaccination antibody titer is \\>0.10 IU/mL and ≤2.7 IU/mL, at least a 4-fold increase in titer; if pre-vaccination antibody titer is\\>2.7 IU/mL, at least a 2-fold increase in titer.'}, {'measure': 'Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen', 'timeFrame': 'Day 28', 'description': 'Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \\>= 0.1 International Units per milliliter (IU/mL).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)', 'timeFrame': 'Day 28', 'description': 'Serological response to PPSV23 was defined as the percentage of participants with a ≥2-fold increase in anti-pneumococcal polysaccharide vaccine titer in \\>5 of the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F'}, {'measure': 'Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)', 'timeFrame': 'Day 28', 'description': 'Serological protection against PPSV23 was defined as the percentage of participants with Anti-pneumococcal polysaccharide IgG concentration \\>= 1.3 μg/mL in the indicated serotypes - 3, 6B, 9N, 11A, 14, 19A, 19F, 22F and 23F associated with increased risk of invasive and/or severe disease, including death.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Day 1 to Day 28', 'description': 'Adverse events include events with onset date on or after the study medication first dose date until end of study visit after the vaccine administration. Serious AEs was defined as is any AE occurring at any dose of vaccination from Day 1 to the end of the study that results in death, Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of death from the AE), Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.'}, {'measure': 'Number of Participants With Abnormalities in Blood Chemistry Parameters', 'timeFrame': 'Day 1 to Day 28', 'description': 'Blood samples were collected to assess laboratory parameters'}, {'measure': 'Number of Participants With Abnormalities in Blood Hematology Parameters', 'timeFrame': 'Day 1 to Day 28', 'description': 'Blood samples were collected to assess laboratory parameters'}, {'measure': 'Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Chemistry Parameters - Albumin', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters.'}, {'measure': 'Change From Baseline in Blood Hematology Parameters - Hematocrit', 'timeFrame': 'Baseline (Day 1) and End of Study (Day 28)', 'description': 'Blood samples were collected to assess laboratory parameters. Participants with baseline and post-baseline data available at the specified timepoint are included in the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Ozanimod', 'Relapsing-remitting multiple sclerosis'], 'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has a diagnosis of multiple sclerosis (MS) according to the 2017 revision of the McDonald diagnostic criteria and has relapsing forms of multiple sclerosis (RMS): relapsing-remitting MS (RRMS) or secondary progressive MS with active disease based on recent clinical relapse or MRI lesion activity.\n\nExclusion Criteria:\n\n* Participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved.\n* Participant has a history of or currently active primary or secondary immunodeficiency.\n* Participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk.\n* Participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to Day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to Day 1.\n* Participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows:\n\n * Any systemic immunosuppressive treatments with potential overlapping effects with the baseline of this study. Corticosteroids that are by non-systemic routes (e.g., topical, inhaled, intra-articular) are allowed.\n* History of treatment with IV immunoglobulin (IVIg) or plasmapheresis within 4 weeks prior to Day 1.'}, 'identificationModule': {'nctId': 'NCT05028634', 'briefTitle': 'Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3b, Multicenter, Open-label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-pegylated Interferon (IFN)-β or No Disease Modifying Therapy', 'orgStudyIdInfo': {'id': 'RPC-1063-MS-010'}, 'secondaryIdInfos': [{'id': '2021-001847-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Ozanimod', 'description': 'Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine\n\n-Enrollment is closed for this cohort', 'interventionNames': ['Biological: Tetanus, diphtheria, and acellular pertussis vaccine', 'Biological: Pneumococcal polysaccharide vaccine', 'Biological: Seasonal influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - non-pegylated interferon-β or no disease modifying therapy', 'description': 'Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), Pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine\n\n-Enrollment is closed for this cohort', 'interventionNames': ['Biological: Tetanus, diphtheria, and acellular pertussis vaccine', 'Biological: Pneumococcal polysaccharide vaccine', 'Biological: Seasonal influenza vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Ozanimod', 'description': 'Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).', 'interventionNames': ['Biological: Tetanus, diphtheria, and acellular pertussis vaccine', 'Biological: Pneumococcal polysaccharide vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - non-pegylated interferon-β or no disease modifying therapy', 'description': 'Comprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap) and Pneumococcal polysaccharide vaccine (PPSV23).', 'interventionNames': ['Biological: Tetanus, diphtheria, and acellular pertussis vaccine', 'Biological: Pneumococcal polysaccharide vaccine']}], 'interventions': [{'name': 'Tetanus, diphtheria, and acellular pertussis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Tdap'], 'description': 'Tdap', 'armGroupLabels': ['Cohort 1 - 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