A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 243
- 主要终点
- Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
研究概览
简要总结
The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.
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
- 70 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese participant
- •Good health or any underlying chronic illness is documented to be in stable condition
- •Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
- •Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination
排除标准
- •Known allergy or sensitivity to any of the components of the study vaccine
- •History of pneumococcal conjugate vaccination
- •Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
- •Functional or anatomic asplenia
- •Received immunoglobulin within 6 months before study vaccine or is planned during the study
- •Received any investigational drugs or vaccines within 2 months before study vaccination
- •History of pneumococcal disease (positive culture from blood or other normally sterile site)
- •Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- •History of convulsion
- •Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
- •Participating in any other clinical trial
结局指标
主要结局
Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
时间窗: Baseline and 4 weeks after revaccination
Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
次要结局
- Percentage of Participants With an Adverse Event of Injection-site Erythema(Up to 5 days after vaccination)
- Percentage of Participants With an Adverse Event of Injection-site Pain(Up to 5 days after vaccination)
- Percentage of Participants With an Adverse Event of Pyrexia(Up to 5 days after vaccination)
- Percentage of Participants With an Adverse Event of Myalgia(Up to 14 days after vaccination)
- Percentage of Participants With an Adverse Event of Arthralgia(Up to 14 days after vaccination)
- Percentage of Participants With an Adverse Event of Headache(Up to 14 days after vaccination)
- Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination(Baseline and 4 weeks after primary vaccination)
- Percentage of Participants With an Adverse Event of Injection-site Swelling(Up to 5 days after vaccination)
- Percentage of Participants With an Adverse Event of Fatigue(Up to 14 days after vaccination)