Status:
COMPLETED
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
Lead Sponsor:
GlaxoSmithKline
Conditions:
Varicella
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00792623
Start Date
September 8 2003
End Date
September 10 2007
Last Update
November 8 2018
Active Locations (3)
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1
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
2
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
3
GSK Investigational Site
Melbourne, Victoria, Australia, 3050