Prevention of herpes zoster in adults with autoimmune disease MedDRA version: 15.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Inactivated Varicella Zoster Virus Vaccine
Product Code: V212
Pharmaceutical Form: Injection
Current Sponsor code: V212
Other descriptive name: V212
Concentration unit: AgU antigen unit(
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is =18 years of age with an autoimmune disease, has clinically stable disease for =30 days prior to enrollment, is receiving treatment with at least one biologic agent or non-biologic therapy at a stable dose for =3 months, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for =30 years (if patient is =65 years) yes F.1.3.1 Number of subjects for this age range 136
Exclusion criteria
Exclusion criteria: Patient has a history of herpes zoster within 1 year of enrollment, has a history of receipt of any varicella or zoster vaccine, has or will receive treatment with any anti-CD20 monoclonal antibody within the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is likely to receive any live virus vaccine during the period from 4 weeks prior to enrollment through 28 days following the last dose of study vaccine, or is likely to receive any inactivated vaccine during the period from 7 days prior to, through 7 days following, any dose of study vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To determine whether V212 is immunogenic when administered to adult patients with autoimmune disease. 2) To assess the safety and tolerability of V212 in adult patients with autoimmune disease.;Secondary Objective: None;Primary end point(s): The primary immunogenicity endpoint is the GMFR of the VZV-specific immune responses from prevaccination to ~28 days Postdose 4.;Timepoint(s) of evaluation of this end point: Day 1 (prior to Dose 1) and Visit 5 (28 days Postdose 4 [+7 days]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Australia, Belgium, Canada, Colombia, Denmark, Estonia, Israel, Netherlands, New Zealand, Peru, Romania, Spain, Sweden, United States
Contacts
Public ContactMedical Monitor
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed