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A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020150-34-DE
Enrollment
1200
Registered
2010-09-09
Start date
2010-10-28
Completion date
Unknown
Last updated
2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of Herpes Zoster in recipients of Autologous HCTs MedDRA version: 17.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Inactivated Varicella Zoster Virus Vaccine Product Code: V212 Pharmaceutical Form: Powder for injection Current Sponsor code: V212 Other descriptive name: Varicella Zoster Virus Inactiva

Sponsors

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient is >18 years of age who has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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, or has had more than 2 relapses of their underlying cancer (If the patient’s underlying cancer is Hodgkin’s lymphoma, more than 2 relapses are permitted). Patients expected to undergo a tandem transplant procedure or expected to receive >6 months (>180 days) of prophylactic antiviral therapy post-HCT.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the safety and tolerability of inactivated VZV vaccine in recipients of autologous HCT and to assess the impact of inactivated VZV vaccine on the development of HZ following autologous HCT;Secondary Objective: To assess the impact of inactivated VZV vaccine on: 1) 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, 2) the development of HZ complications, and 3) the development of PHN.;Primary end point(s): The primary clinical efficacy endpoint will be the incidence of HZ.—

Countries

Belgium, Germany, Italy, Lithuania, Netherlands, Portugal, Spain, Sweden, United Kingdom

Contacts

Public ContactAndreas Ketter

MSD Sharp & Dohme GmbH

andreas.ketter@msd.de+498945611250

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026