Randomized, double-blind, placebo-controled stdy to assess the safety &tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM)& determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM as compared to placebo

Phase 3

Conditions: Health Condition 1: null- Herpes zosterHealth Condition 2: D480- Neoplasm of uncertain behavior ofbone and articular cartilage

Registration Number: CTRI/2012/05/002673

Lead Sponsor: Merck Sharp and Dohme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 5264

Inclusion Criteria

Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and:

Participant is >=18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen that does not include rituximab.

Participant is >= 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not, and is not expected to need rituximab therapy within 3 months prior to enrollment on this study through 28 days after receiving vaccination dose 4.

Participant has a life expectancy >= 12 months.

Participant has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.

Exclusion Criteria

-articipant has a history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.

Participant has a prior history of HZ within 1 year of enrollment.

Participant has received any varicella or zoster vaccine.

Participant is currently receiving or expected to receive long-term antiviral prophylaxis (4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV).

Participant is receiving or expected to receive a chemotherapy regimen containing Rituximab.

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.

Participant has had any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4.

Participant has had inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of herpes zoster (HZ) cases per <br/ ><br>1000 person-years of follow-up <br/ ><br>2. The number of participants experiencing <br/ ><br>serious adverse eventsTimepoint: Jun-2016

Secondary Outcome Measures