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.

Phase 1

• Conditions: Incidence of Herpes Zoster in adults with solid tumor or hematologic malignancy.; MedDRA version: 16.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-023156-89-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5264

Inclusion Criteria

Patient is =18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.

Patient is =50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant, and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of V212 (inactivated VZV vaccine) in adults with solid tumor or hematologic malignancy and to assess the impact of inactivated VZV vaccine on the development of HZ in adults with solid tumor or hematologic malignancy;Secondary Objective: To assess the impact of inactivated VZV vaccine on: <br>1) the development of V212 in adults with STM; <br>2) the development of V212 in adults with HM; <br>3) the development of moderate to severe HZ-associated pain at any time from HZ onset through the end of the 6 month HZ follow-up period; <br>4) the development of HZ complications<br>5) the development of PHN.;Primary end point(s): The primary clinical efficacy endpoint is the incidence of herpes zoster.;Timepoint(s) of evaluation of this end point: time period from dose 4 until end of study. Event driven study until 232HZ have been accrued

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Five secondary endpoints are defined:<br>- incidence of HZ for HM subgroup<br>- incidence of HZ for STM subgroup<br>- HZ pain analyse according to ZBPI questionnaire <br>- HZ-associated complications<br>- incidence of PHN;Timepoint(s) of evaluation of this end point: time period from dose 4 until end of study. Event driven study until 232HZ have been accrued. At least one year FU for each patient in the study.