NCT05019248

Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine

A Non-interventional Observation Study to Evaluate Immune Responses Following Seasonal Influenza Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Cladribine Tablets

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to characterize the antibody response to seasonal influenza vaccine, in patients with active RRMS, treated with cladribine, compared to control individuals with basic immunomodulatory treatment. Serum antibody titers against the respective pathogen will be assessed prior to and 6 to 8 months following vaccination.

Conditions

• Multiple Sclerosis, Relapsing-Remitting
• Vaccine Response Impaired

Interventions

Type	Name	Description
BIOLOGICAL	Most recent vaccine to seasonal influenza	Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-31
• Completion: 2022-04-30
• First posted: 2021-08-24
• Last updated: 2021-08-24

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study