NCT00792623已完成2 期
A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given as a Primary Vaccination at 4.5 Months and 6.5 Months Post-transplantation, in Autologous Stem Cell/ Bone Marrow Transplant Recipients Aged 18 Years and Older.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Varilrix Group
Experimental
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.
干预措施: VarilrixTM (Biological)
结局指标
主要结局
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
时间窗: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Number of Subjects With a Varicella Vaccine Response
时间窗: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.
次要结局
- Number of Subjects With a Varicella Vaccine Response(At 6.5 months post-transplantation = 2 months post first dose of vaccination)
- Number of Subjects With Any and Related Rash(During the 43-day (Days 0-42) post-vaccination period after each dose and across doses)
- Number of Subjects With Serious Adverse Events (SAEs)(During the active phase of the study (up to Month 24))
- Number of Seropositive Subjects for Anti-varicella Antibodies(At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination))
- Number of Subjects With Any and Grade 3 Solicited Local Adverse Events(During the 8-day (Days 0-7) post-vaccination period after each dose and across doses)
- Anti-varicella Antibody Titers(At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination))
- Number of Subjects With Any Fever(During the 43-day (Days 0-42) post-vaccination period after each dose and across doses)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 43-day (Days 0-42) post-vaccination period after each dose and across doses)
研究者
研究点 (4)
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