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Pneumococcal polysaccharide vaccine

Phase 3

Multiple Sclerosis | Monoclonal antibody | Neurology |Bristol-Myers Squibb Company|Last Updated: Feb 11, 2025

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

Pneumococcal polysaccharide vaccine · 1 trial · 2 indications

Phase 3 1
NCT05028634Safety 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 TherapyMultiple Sclerosis
COMPLETED63 Analytics
PHASE3COMPLETED
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
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Day 28

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.

Percentage of Participants Meeting Immune Serological Protection Criteria to Tetanus Toxoid Antigen
Day 28

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

Secondary Endpoints

Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)
Day 28
Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)
Day 28
Number of Participants With Adverse Events
Day 1 to Day 28
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 - OzanimodEXPERIMENTALComprises 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
Cohort 1 - non-pegylated interferon-β or no disease modifying therapyEXPERIMENTALComprises 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
Cohort 2 - OzanimodEXPERIMENTALComprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Cohort 2 - non-pegylated interferon-β or no disease modifying therapyEXPERIMENTALComprises 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).

Interventions

NameTypeDescription
Tetanus, diphtheria, and acellular pertussis vaccineBIOLOGICALTdap
Pneumococcal polysaccharide vaccineBIOLOGICALPPSV23
Seasonal influenza vaccineBIOLOGICALSeasonal influenza vaccine
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * 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...

Countries:United StatesGermany
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Frequently asked questions about Pneumococcal polysaccharide vaccine

What is Pneumococcal polysaccharide vaccine used for in Multiple Sclerosis?

Pneumococcal polysaccharide vaccine is being studied in participants with relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis. The vaccine is evaluated for its immune response when given alongside the disease-modifying therapy ozanimod, compared to non-pegylated interferon beta or no disease-modifying therapy.

Who makes Pneumococcal polysaccharide vaccine?

Pneumococcal polysaccharide vaccine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this vaccine in the context of multiple sclerosis treatment.

What phase is Pneumococcal polysaccharide vaccine in?

Pneumococcal polysaccharide vaccine is in Phase 3 clinical development. It is an investigational product, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for its safety and immune response in multiple sclerosis patients.

What clinical trials is Pneumococcal polysaccharide vaccine in?

Pneumococcal polysaccharide vaccine is being studied in clinical trial NCT05028634, a Phase 3 study that has been completed. The trial enrolled 63 participants with relapsing forms of multiple sclerosis and was conducted in the United States and Germany.

Is Pneumococcal polysaccharide vaccine the same as a standard pneumococcal vaccine?

Pneumococcal polysaccharide vaccine is a vaccine designed to elicit an immune response against pneumococcal bacteria. In the context of this clinical trial, it is being used to assess immune response in multiple sclerosis patients receiving different disease-modifying therapies, rather than as a treatment for multiple sclerosis itself.