An Open-Label, Multicenter, Single-arm Study to Evaluate the Immunogenicity of VARIVAX™ in Healthy Russian Individuals 12 Months of Age and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
研究概览
简要总结
The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •has a negative clinical history for varicella and herpes zoster
- •females of reproductive potential have a negative pregnancy test prior to each study vaccination
- •females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study until 3 months following last study vaccination
- •females not of reproductive potential do not require a pregnancy test or use of contraceptives
- •legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures
排除标准
- •has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX^TM
- •has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
- •has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
- •has received aspirin or any aspirin-containing products within prior 14 days
- •has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
- •has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
- •has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
- •was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
- •had a fever within 72 hours prior to study vaccination
- •has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
- •is pregnant or nursing
结局指标
主要结局
Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
时间窗: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was \<1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
时间窗: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer \<1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
时间窗: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline.
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
时间窗: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
时间窗: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group.
Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline
时间窗: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)
GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group.
次要结局
- Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1(Up to approximately 42 days post-Vaccination 1)
- Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2(Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days))
- Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1(Up to approximately 42 days post-Vaccination 1)
- Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2(Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days))
- Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2(Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days))
- Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1(Up to approximately 5 days post-Vaccination 1)
- Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2(Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days))
- Percentage of Participants With Elevated Temperature Post-Vaccination 1(Up to 28 days post-Vaccination 1)
- Percentage of Participants With Elevated Temperature Post-Vaccination 2(Up to 28 days post-Vaccination 2 (up to approximately 71 days))
- Percentage of Participants With Systemic AEs Post-Vaccination 1(Up to approximately 42 days post-Vaccination 1)
- Percentage of Participants With Systemic AEs Post-Vaccination 2(Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days))
- Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2(Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days))
- Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2(Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days))