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Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

NCT02097849 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-06-02

Study results available
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Summary

Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN).

Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].

Conditions

  • Relapsing Forms of Multiple Sclerosis

Interventions

DRUG

dimethyl fumarate

Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.

BIOLOGICAL

tetanus diphtheria toxoids vaccine

Administered as described in the treatment arm

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Administered as described in the treatment arm

BIOLOGICAL

meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)

Administered as described in the treatment arm

DRUG

non-pegylated interferon

Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-05-02
Completion
2016-05-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097849 on ClinicalTrials.gov