Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02097849
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2014-03-25
Brief Title:
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera BG00012-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None