A clinical research study to test the safety, tolerability and effectiveness of the investigational vaccine to prevent shingles in individuals with weak immune system such as people with cancer.

Phase 1

• Conditions: Incidence of Herpes Zoster in adults with solid tumor or hematologic malignancy; MedDRA version: 18.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5136

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2632
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2632

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