Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Varicella

Treatments: Biological: VarilrixTM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792623

208133/178

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Varilrix Group

Experimental group

Description:

Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.

Treatment:

Biological: VarilrixTM