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 AM3)
Trial Sites
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care | Active | 18 and over | Pharmaceutical / Industry | V212-011 NCT01254630 |
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) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.
Eligibility Criteria
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
- Participant is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not
- 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:
- Participant 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 or is expected to receive any varicella or non-study 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 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.
Trial Lead Organizations/Sponsors
Merck and Company, Incorporated
| Toll Free Number |  | Ph: 1-888-577-8839 |
Trial Sites
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| Argentina | |||
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| Bangkok | |||
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|||
| MSD (Thailand) Ltd. | |||
| Suchai Kitsiripornchai | Ph: 66 22555090 EXT.25746 | ||
| Turkey | |||
|
|||
| Istanbul | |||
|
|||
| Merck Sharp & Dohme Ilaclari Ltd. Sti | |||
| Alev Eren | Ph: 90 212 336 12 63 | ||
| United Kingdom | |||
|
|||
| Hoddesdon | |||
|
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| Merck Sharp & Dohme Ltd. | |||
| Paul Robinson | Ph: 44 1992452396 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01254630
Information obtained from ClinicalTrials.gov on May 12, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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