Prevention of herpes zoster in adults with autoimmune disease
Conditions
Interventions
Product Name: V212
Product Code: V212
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
Current Sponsor code: V212
Other descriptive name: Inactivated varicella-zoster virus (VZ
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be 50 to 59 years of age (at time of informed consent) 2 .Be afebrile (=100.4° F[=38.0°C]) oral or equivalent on Day 1 prior to first vaccination. Note: Should a subject meets all additional inclusion/exclusion criteria requiring for entry into the study but are currently febrile, then enrollment may be delayed until the above criteria is met. 3. Any underlying chronic illness must be in stable condition. 4. Have a history of varicella, antibodies to VZV, or residence (for =30 years) in a country with endemic VZV infection. 5. All female subjects of childbearing potential must have a negative serum or urine pregnancy test (sensitive to 25 IU ß-hCG). 6. Be highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 315 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has a prior history of HZ. 2. Has had prior receipt or any expected receipt during the study period of any varicella or zoster vaccine. 3. Has had any live virus vaccine administered or is scheduled to receive any live virus vaccine in the period from 4 weeks prior to Visit 1 through Visit 5. 4. Any inactivated vaccine administered or is scheduled to receive within the period from 7 days prior, through 7 days following any dose of study vaccine. 5. Has had immunoglobulin or any blood products administered or is scheduled to receive immunoglobulin or any blood products in the period from 5 months prior to Visit 1 through Visit 5. 6. Is receiving immunosuppressive therapy. 7. Has known or suspected immune dysfunction that is caused by a medical condition, or any other cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether V212 from three consistency lots have similar immunogenicity.;Secondary Objective: To determine the safety and tolerability of V212 from three consistency lots. ;Primary end point(s): Geometric mean titer (GMT) in VZV gpELISA antibody titers measured at 28 days Postdose 4;Timepoint(s) of evaluation of this end point: Day 1 (prior to Dose 1) and 28 days Postdose 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Israel, Sweden, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Outcome results
None listed