Multiple SclerosisPhase 3NCT05028634
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
A Phase 3 study testing Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine and Seasonal influenza vaccine in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Celgene at 33 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine and Seasonal influenza vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 11 Nov 2021to 15 Nov 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 relapse or MRI lesion activity.
Who cannot join
- Participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved.
- Participant has a history of or currently active primary or secondary immunodeficiency.
- Participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk.
- Participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to Day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to Day 1.
- Participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows:
- Any systemic immunosuppressive treatments with potential overlapping effects with the baseline of this study. Corticosteroids that are by non-systemic routes (e.g., topical, inhaled, intra-articular) are allowed.
- History of treatment with IV immunoglobulin (IVIg) or plasmapheresis within 4 weeks prior to Day 1.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States29 sites
Neuromedical Clinic of Central LA
Alexandria, Louisiana, 71301
Asheville Neurology Specialists PA
Asheville, North Carolina, 28806
Local Institution - 105
Canton, Ohio, 44718
University of Chicago Medicine
Chicago, Illinois, 60637
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland, Ohio, 44122
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Vaught Neurological Services, PLLC
Crab Orchard, West Virginia, 25827
Michigan State University MS Clinic
East Lansing, Michigan, 48824
Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035
University of Florida Health
Gainesville, Florida, 32610
Local Institution - 111
Kansas City, Kansas, 66205
Hope Neurology MS Center
Knoxville, Tennessee, 37922
Neurology Associates PC
Lincoln, Nebraska, 68506
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Shapiro Center for MS at the Minneapolis Clinic of Neurology
Minneapolis, Minnesota, 55422
Lake Norman Neurology
Mooresville, North Carolina, 28117
Jersey Shore MS Center
Neptune City, New Jersey, 07753
Consultants In Neurology
Northbrook, Illinois, 60062
CPFCC Neurology Research Dept.
Overland Park, Kansas, 66212
Stanford University
Palo Alto, California, 94304
South Shore Neurology Associates, Inc
Patchogue, New York, 11772
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Neurostudies Inc
Port Charlotte, Florida, 33952
Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS
Port Orange, Florida, 32127
Central Texas Neurology Consultants PA
Round Rock, Texas, 78681
Sanford Health
Sioux Falls, South Dakota, 57104
Hartford Healthcare CT
Southington, Connecticut, 06489
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
Holy Name Hospital
Teaneck, New Jersey, 07666
Germany4 sites
Local Institution - 200
Bochum, 44791
Local Institution - 201
Dresden, 01307
Local Institution - 206
Mannheim, 68163
Local Institution - 204
Rostock, 18147
About this study
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
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.
- Being tested
- Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine, Seasonal influenza vaccine
- Keywords
- Multiple Sclerosis, Ozanimod, Relapsing-remitting multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus, diphtheria, and acellular pertussis vaccineBiological
Also called Tdap
Tdap
Pneumococcal polysaccharide vaccineBiological
Also called PPSV23
PPSV23
Seasonal influenza vaccineBiological
Seasonal influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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). Receives: Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Biological: Pneumococcal polysaccharide vaccine |
| 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). Receives: Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Biological: Pneumococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Day 28
Secondary outcomes (17)
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
Measured: Day 28
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.
Measured: Day 28
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.
Measured: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Chemistry Parameters
Blood samples were collected to assess laboratory parameters
Measured: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Hematology Parameters
Blood samples were collected to assess laboratory parameters
Measured: Day 1 to Day 28
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.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Albumin
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
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.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to assess laboratory parameters.
Measured: Baseline (Day 1) and End of Study (Day 28)
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.
Measured: Baseline (Day 1) and End of Study (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start11 Nov 2021
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028634
- Sponsor's protocol ID
- RPC-1063-MS-010
- Other IDs
- 2021-001847-28
- Status last verified
- Jan 2025
- First submitted
- 25 Aug 2021
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05028634
- Acronym / sponsor ID
- RPC-1063-MS-010
- Keywords
- Multiple Sclerosis, Ozanimod, Relapsing-remitting multiple sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Ozanimod | Experimental | Biological: Tetanus, diphtheria, and acellular pertussis vaccine, Biological: Pneumococcal polysaccharide vaccine, Biological: Seasonal influenza vaccineComprises 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 | Biological: Tetanus, diphtheria, and acellular pertussis vaccine, Biological: Pneumococcal polysaccharide vaccine, Biological: Seasonal influenza vaccineComprises 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 | Biological: Tetanus, diphtheria, and acellular pertussis vaccine, Biological: Pneumococcal polysaccharide vaccineComprises 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 | Biological: Tetanus, diphtheria, and acellular pertussis vaccine, Biological: Pneumococcal polysaccharide vaccineComprises 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 relapse or MRI lesion activity.
Key exclusion criteria (7 listed)
- Participant has history of cancer, including solid tumors and hematological except for basal cell cancer of the skin and carcinoma in situ of the cervix, which are exclusionary if they have not been excised and resolved.
- Participant has a history of or currently active primary or secondary immunodeficiency.
- Participant has severely compromised cardiac or pulmonary function for which a systemic hypersensitivity reaction to any of the vaccines would pose a significant risk.
- Participant has received the seasonal influenza vaccine for the 2021/2022 influenza season prior to Day 1, or history of influenza vaccine for the 2020/2021 influenza season within 6 months prior to Day 1.
- Participant has previous treatment with one of the following medications or interventions within the corresponding timeframe described as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus, diphtheria, and acellular pertussis vaccineAlso: TdapTdap | Biological | Cohort 1 - Ozanimod, Cohort 1 - non-pegylated interferon-β or no disease modifying therapy, Cohort 2 - Ozanimod, Cohort 2 - non-pegylated interferon-β or no disease modifying therapy |
| Pneumococcal polysaccharide vaccineAlso: PPSV23PPSV23 | Biological | Cohort 1 - Ozanimod, Cohort 1 - non-pegylated interferon-β or no disease modifying therapy, Cohort 2 - Ozanimod, Cohort 2 - non-pegylated interferon-β or no disease modifying therapy |
| Seasonal influenza vaccineSeasonal influenza vaccine | Biological | Cohort 1 - Ozanimod, Cohort 1 - non-pegylated interferon-β or no disease modifying therapy |
Primary outcome
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen
Time frame: 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
Time frame: Day 28
Participants with Serological protection to tetanus toxoid have anti-tetanus toxoid IgG concentration >= 0.1 International Units per milliliter (IU/mL).
17 secondary outcomes
Percentage of Participants With Serologic Response to Pneumococcal Polysaccharide Vaccine (PPSV23)
Time frame: Day 28
Percentage of Participants With Serologic Protection Against Pneumococcal Polysaccharide Vaccine (PPSV23)
Time frame: Day 28
Number of Participants With Adverse Events
Time frame: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Chemistry Parameters
Time frame: Day 1 to Day 28
Number of Participants With Abnormalities in Blood Hematology Parameters
Time frame: Day 1 to Day 28
Change From Baseline in Blood Chemistry Parameters - Sodium; Potassium; Chloride; Calcium; Magnesium; Phosphate; Blood Urea Nitrogen; Glucose
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Creatinine; Bilirubin; Direct Bilirubin
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Albumin
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alkaline Phosphatase
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Chemistry Parameters - Alanine Aminotransferase; Aspartate Aminotransferase; Gamma Glutamyl Transferase
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Leukocytes; Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils; Platelets
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Basophils/Leukocytes; Eosinophils/Leukocytes; Lymphocytes/Leukocytes; Monocytes/Leukocytes; Neutrophils/Leukocytes
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Hemoglobin; Erythrocytes Mean Corpuscular HGB Concentration
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Volume
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Erythrocytes Mean Corpuscular Hemoglobin
Time frame: Baseline (Day 1) and End of Study (Day 28)
Change From Baseline in Blood Hematology Parameters - Hematocrit
Time frame: Baseline (Day 1) and End of Study (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetanus, diphtheria, and acellular pertussis vaccine, Pneumococcal polysaccharide vaccine and Seasonal influenza vaccine in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Celgene at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Meeting Immune Serological Response Criteria to Tetanus Toxoid Antigen (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.