Approval Probability
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Pneumococcal polysaccharide vaccine · 1 trial · 2 indications
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.
Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration \>= 0.1 International Units per milliliter (IU/mL).
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| 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). |
| Cohort 2 - 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) and Pneumococcal polysaccharide vaccine (PPSV23). |
| Name | Type | Description |
|---|---|---|
| Tetanus, diphtheria, and acellular pertussis vaccine | BIOLOGICAL | Tdap |
| Pneumococcal polysaccharide vaccine | BIOLOGICAL | PPSV23 |
| Seasonal influenza vaccine | BIOLOGICAL | Seasonal influenza vaccine |
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...
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.
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.
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.
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.
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.