IRB #

IRB00008027

Title

A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy

Principal Investigator

Gary Takahashi

Study Purpose

To assess the safety and tolerability of the study vaccine V212 and it's ability to prevent shingles in subjects with solid tumor or hematologic malignancies

Medical Condition(s)

Eligibility Criteria

1. Subjects diagnosed with a solid tumor or hematologic malignancy AND are not likely to undergo hematopoietic cell transplant (HCT).
Must meet one of the following criteria:
-18 years of age or older and is receiving a cytotoxic or immunosuppressive
chemotherapy regimen that does not include rituximab
- Is 50 years of age or older with a hematologic malignancy, not in remission,
regardless of whether the patient is or is not receiving chemotherapy
AND
- Is not receiving and not expected to require rituximab therapy beginning 3 months
prior to enrollment through 28 days postvaccination dose 4.
2. Life expectancy ≥ 12 months.
3. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt
of blood products), or residence (for ≥30 years) in a country with endemic VZV
infection, or if participant is 30 years old, attended primary or secondary school in a
country with endemic VZV infection

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Approximately 5 years

Minors Included

No

Contact

Community Oncology 503-601-7641

Sponsor

Merck & Co., Inc

Recruitment End

04/17/2016

Compensation Provided

No