Safety Study to Evaluate Immune Response of Vaccines in P... | NCT05028634

NCT05028634

ID	Type	Description	Link
2021-001847-28	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1 - Ozanimod	Experimental	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 -Enrollment is closed for this cohort	Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Pneumococcal polysaccharide vaccine Biological: Seasonal influenza vaccine
Cohort 1 - non-pegylated interferon-β or no disease modifying therapy	Experimental	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 -Enrollment is closed for this cohort	Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Pneumococcal polysaccharide vaccine Biological: Seasonal influenza vaccine
Cohort 2 - Ozanimod	Experimental	Comprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).	Biological: Tetanus, diphtheria, and acellular pertussis vaccine Biological: Pneumococcal polysaccharide vaccine
Cohort 2 - non-pegylated interferon-β or no disease modifying therapy	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tetanus, diphtheria, and acellular pertussis vaccine	Biological	Tdap	Cohort 1 - Ozanimod Cohort 1 - non-pegylated interferon-β or no disease modifying therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen	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.	Day 28
Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen	Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration >= 0.1 International Units per milliliter (IU/mL).	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)	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	Day 28

Eligibility Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	94304	United States
Colorado Springs Neurological Associates

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ozanimod	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 29, 2022

Arm/Group Information

ID	Title	Description
BG000	Ozanimod	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.
BG001	Non-Ozanimod	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.1± 9.03 BG00146.8± 6.83 BG00245.0± 8.09

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00021 BG00121 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen

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.

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.

Posted

Number

percentage of participants

Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Units	Counts
Participants	OG00030 OG00132

Title

Denominators

Categories

Title	Measurements
	OG00010 OG00153.1

Primary

Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen

Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration >= 0.1 International Units per milliliter (IU/mL).

Posted

Number

percentage of participants

Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)

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

Posted

Number

percentage of participants

Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)

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.

Posted

Number

percentage of participants

Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Number of Participants With Adverse Events

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.

Posted

Count of Participants

Participants

Day 1 to Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Number of Participants With Abnormalities in Blood Chemistry Parameters

Blood samples were collected to assess laboratory parameters

Posted

Count of Participants

Participants

Day 1 to Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Units	Counts
Participants

Secondary

Number of Participants With Abnormalities in Blood Hematology Parameters

Blood samples were collected to assess laboratory parameters

Posted

Count of Participants

Participants

Day 1 to Day 28

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Units

Secondary

Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

mmol/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

umol/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Chemistry Parameters - Albumin

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

g/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Units

Secondary

Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

IU/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

U/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Erythrocytes

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

10^12 cells per liter

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

10^9 cells per liter

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

percentage

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

g/L

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin

Blood samples were collected to assess laboratory parameters.

Posted

Mean

Standard Deviation

pg/cell

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Secondary

Change From Baseline in Blood Hematology Parameters - Hematocrit

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.

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Baseline (Day 1) and End of Study (Day 28)

ID	Title	Description
OG000	Ozanimod	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.
OG001	Non-Ozanimod	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ozanimod	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.	0	30	0	30	5	30
EG001	Non-Ozanimod	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.	0	33	0	33	7	33

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 affected30 at risk EG0014 affected33 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines
D022242	Pneumococcal Vaccines
C414006	23-valent pneumococcal capsular polysaccharide vaccine

ID	Term
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit
D022541	Streptococcal Vaccines

ID	Term
D009103	Multiple Sclerosis
D020529	Multiple Sclerosis, Relapsing-Remitting