A Phase 3, Open-Label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13vPnC When Administered to Healthy Japanese Adults Aged >= 65 Years and 50 to 64 Years in Japan Who Have Not Received a Previous Dose of 23-Valent Pneumococcal Polysaccharide Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 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
- •Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age.
- •Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
- •Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.
排除标准
- •History of severe adverse reaction associated with a vaccine.
- •Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
- •Documented S pneumoniae infection within the past 5 years before study vaccination.
结局指标
主要结局
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population
时间窗: Prevaccination (Day 1), 1 month after vaccination
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
时间窗: Prevaccination (Day 1), 1 month after vaccination
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population
时间窗: 1 month after vaccination
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years
时间窗: 1 month after vaccination
Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
次要结局
- Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(1 month after vaccination)
- Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(1 month after vaccination)
- Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population(Day 1 through 14)
- Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(1 month after vaccination)
- Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group(1 month after vaccination)
- Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population(1 month after vaccination)
- Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population(Day 1 through 14)
- Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population(1 month after vaccination)
- Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population(1 month after vaccination)
- Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(1 month after vaccination)
- Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population(1 month after vaccination)
- Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group(1 month after vaccination)
- Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group(1 month after vaccination)
- Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population(1 month after vaccination)
- Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group(1 month after vaccination)
- Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group(1 month after vaccination)
- Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(1 month after vaccination)
- Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(Day 1 through 14)
- Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years(Day 1 through 14)