Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammat...
Eligibility Criteria
Inclusion
- Diagnosed with an autoimmune disease
- Clinically stable disease for at least 30 days before enrollment
- Not likely to undergo hematopoietic stem cell transplantation during the study period
- Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
- History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection
Exclusion
- Prior history of Herpes Zoster (shingles) within 1 year before enrollment
- Prior varicella or zoster vaccine
- Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
- Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
- Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment
Key Trial Info
Start Date :
February 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2013
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT01527383
Start Date
February 21 2012
End Date
February 26 2013
Last Update
January 14 2019
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