Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 mo...
Eligibility Criteria
Inclusion
- Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies and is not likely to undergo hematopoietic cell transplant (HCT).
- Has a predicted life expectancy of ≥ 12 months.
- Has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.
- All female participants of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion
- A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
- Prior history of HZ within 1 year of enrollment.
- Prior receipt of any varicella or zoster vaccine.
- Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
- Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
- Participant is currently participating or has participated in a study with an investigational anti-CD20 monoclonal antibody within 3 months of signing informed consent.
Key Trial Info
Start Date :
January 24 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01460719
Start Date
January 24 2012
End Date
September 25 2012
Last Update
March 11 2019
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