Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
研究概览
简要总结
This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.
详细描述
All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Groups:
- •Must not have a fever of ≥100.4° F on the day of vaccination
- •Any underlying chronic illness must be in stable condition
- •History of varicella or residence in a VZV-endemic area for ≥30 years
- •70 years of age or older
- •Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
- •70 years of age or older
- •60 to 69 years of age
- •50 to 59 years of age
排除标准
- •All Groups:
- •History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
- •Prior history of herpes zoster
- •Pregnant or breast-feeding, or expecting to conceive within the duration of the study
- •Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
- •Received any other vaccine within 4 weeks prevaccination
- •On immunosuppressive therapy
- •Has known or suspected immune dysfunction
- •Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
- •Groups 2, 3, and 4:
- •Has previously received any varicella or zoster vaccine
结局指标
主要结局
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
时间窗: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
时间窗: Day 1 (Baseline) and Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
次要结局
- Number of Participants Reporting One or More Adverse Experiences(Up to 42 days postvaccination)