Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Intervention: VarilrixTM
Intervention description: Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Varicella; VarilrixTM

Summary:

      This study aims to assess the immunogenicity and safety of varicella vaccination in a
      population of autologous peripheral stem cell/ bone marrow transplantation recipients who
      have reached at least four months post-transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

        Screening phase:

          -  A male or female ≥ 18 years of age at the time of study entry.

          -  Written informed consent obtained from the subject prior to study entry.

          -  Patients who are planned to undergo autologous peripheral stem cell/ bone marrow
             transplantation.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  If the subject is female, she must be of non-childbearing potential; or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for 10 months after transplantation.

        Active phase:

          -  Patients who are confirmed to have undergone autologous peripheral stem cell/ bone
             marrow transplantation.

          -  If the subject is female, she must be of non-childbearing potential; or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for 10 months after transplantation.

        Exclusion Criteria:

        Screening phase:

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions in the 10 months post-transplantation.

          -  History of allergy to any component of the vaccine.

          -  Patients with difficult to treat disease who are likely to relapse within 6 months
             post-transplantation.

          -  Current drug and/or alcohol abuse.

        Active phase:

          -  Use of any investigational or non-registered product (drug or vaccine) during the
             active phase of the study period.

          -  Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the
             administration of the first dose of the study vaccine or planned use during the active
             phase of the study period.

          -  Use of rituximab (MabThera) more than 60 days after transplant.

          -  Administration of a vaccine not foreseen by the study protocol during the period
             starting from 30 days before each dose of vaccine and ending 30 days after.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions in the 10 months post-transplantation.

          -  History of allergy to any component of the vaccine

          -  Patients with VZV disease after transplantation and prior to vaccination.

          -  Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months
             post-transplantation

          -  Patients with difficult to treat disease who are likely to relapse within 6 months
             post-transplantation.

          -  Current drug and/or alcohol abuse.