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: Adult patients with solid tumor or hematologic malignancy.
MedDRA version: 14.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2010-023156-89-IT

Lead Sponsor: MERCK SHARP & DOHME CORP.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5305

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, and has not/will not be treated with rituximab in the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, 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, and has not/will not be treated with rituximab from 3 months prior to enrolment through 28 days following the last dose of study vaccine 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3624
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1812

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 has been treated with rituximab or is expected to be treated with rituximab in the period from 3 months prior to enrolment through 28 days following the last dose of study vaccine 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: 1) the development of V212 in adults with STM; 2) the development of V212 in adults with HM; 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; 4) the development of HZ complications, and 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: The primary safety endpoint of the study will be based on the incidence of serious adverse experiences observed during the period up to 28 days Postdose 4 in each vaccination group.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Three secondary efficacy endpoints are defined for this protocol. The first is the incidence of moderate to severe HZ-associated pain. The second is a composite efficacy endpoint of the incidence of HZ complications. The third endpoint is the incidence of PHN;Timepoint(s) of evaluation of this end point: First endoint: at any time from HZ onset through the end of the 6 month HZ-follow-up period. Second endpoint:during all the study Third endpoint: 90 days after the onset of the HZ rash

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