Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) receiving chemotherapy and to a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and is either ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen OR is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not
- Life expectancy ≥12 months
- Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is \<30 years old, attended primary or secondary school in a country with endemic VZV infection
- Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose
- Female participants of childbearing potential must have a negative serum or urine pregnancy test
- Exclusion criteria:
- History of hypersensitivity reaction to any vaccine component
- Prior history of Herpes Zoster within 1 year of enrollment
- Has received or is expected to receive any varicella or non-study zoster vaccine
- Currently receiving or expected to receive long-term antiviral prophylaxis (\>4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV)
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months from last vaccination dose
- Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4
- Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4
Exclusion
Key Trial Info
Start Date :
June 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2017
Estimated Enrollment :
5305 Patients enrolled
Trial Details
Trial ID
NCT01254630
Start Date
June 24 2011
End Date
April 11 2017
Last Update
September 30 2019
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