CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Tetanus, diphtheria, and acellular pertussis vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05028634
NCT05028634Phase 3Completed

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

Celgene·interventional·Posted Aug 31, 2021·Updated Feb 11, 2025

In Brief

A Phase 3 clinical trial evaluating Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine, and 1 other intervention for Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 63 participants across 33 sites in 2 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 31, 2021
Enrollment StartNov 11, 2021
Primary CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.8 years ago

Interventions

Tetanus, diphtheria, and acellular pertussis vaccinebiological

Tdap

Pneumococcal polysaccharide vaccinebiological

PPSV23

Seasonal influenza vaccinebiological

Seasonal influenza vaccine