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 Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
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 efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of a...
Detailed Description
Study participants were randomized to receive one of 3 consistency lots of V212, a high antigen lot of V212, or placebo. To comply with regulatory requests, results for all lots of V212 were combined ...
Eligibility Criteria
Inclusion
- 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.
- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment
- 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
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster within 1 year of enrollment
- Prior receipt of any varicella or zoster vaccine
- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)
- Expectation of tandem transplant procedure
- Is expected to receive \>6 months (\>180 days) of prophylactic antiviral therapy post-HCT.
- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 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.
Key Trial Info
Start Date :
November 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2015
Estimated Enrollment :
1257 Patients enrolled
Trial Details
Trial ID
NCT01229267
Start Date
November 30 2010
End Date
December 23 2015
Last Update
September 30 2019
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