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
Public ClinicalTrials.gov record NCT05028634. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05028634
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Interventions
- Tetanus, diphtheria, and acellular pertussis vaccine Biological
- Pneumococcal polysaccharide vaccine Biological
- Seasonal influenza vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 11, 2021 (Actual)
- Primary completion
- Nov 15, 2023 (Actual)
- Completion
- Nov 15, 2023 (Actual)
- Last update posted
- Feb 11, 2025
2021 – 2023
United States locations
- U.S. sites
- 29
- U.S. states
- 22
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Hartford Healthcare CT | Southington | Connecticut | 06489 | — |
| University of Florida Health | Gainesville | Florida | 32610 | — |
| Neurostudies Inc | Port Charlotte | Florida | 33952 | — |
| Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS | Port Orange | Florida | 32127 | — |
| University of Chicago Medicine | Chicago | Illinois | 60637 | — |
| Consultants In Neurology | Northbrook | Illinois | 60062 | — |
| Local Institution - 111 | Kansas City | Kansas | 66205 | — |
| CPFCC Neurology Research Dept. | Overland Park | Kansas | 66212 | — |
| Neuromedical Clinic of Central LA | Alexandria | Louisiana | 71301 | — |
| Neurology Center of New England P.C. | Foxborough | Massachusetts | 02035 | — |
| Michigan State University MS Clinic | East Lansing | Michigan | 48824 | — |
| Shapiro Center for MS at the Minneapolis Clinic of Neurology | Minneapolis | Minnesota | 55422 | — |
| Neurology Associates PC | Lincoln | Nebraska | 68506 | — |
| Jersey Shore MS Center | Neptune City | New Jersey | 07753 | — |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | — |
| South Shore Neurology Associates, Inc | Patchogue | New York | 11772 | — |
| Asheville Neurology Specialists PA | Asheville | North Carolina | 28806 | — |
| Lake Norman Neurology | Mooresville | North Carolina | 28117 | — |
| Local Institution - 105 | Canton | Ohio | 44718 | — |
| Velocity Clinical Research - Cleveland - ERN - PPDS | Cleveland | Ohio | 44122 | — |
| Thomas Jefferson University - Clinical Research Institute | Philadelphia | Pennsylvania | 19107 | — |
| Sanford Health | Sioux Falls | South Dakota | 57104 | — |
| Hope Neurology MS Center | Knoxville | Tennessee | 37922 | — |
| Central Texas Neurology Consultants PA | Round Rock | Texas | 78681 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
| Vaught Neurological Services, PLLC | Crab Orchard | West Virginia | 25827 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05028634, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05028634 live on ClinicalTrials.gov.