A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 764
- 试验地点
- 8
- 主要终点
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
- •Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.
排除标准
- •History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
- •Previous vaccination with any licensed or experimental pneumococcal vaccine.
- •Documented Streptococcus pneumoniae infection within the past 5 years.
- •Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
结局指标
主要结局
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
时间窗: One month after vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
时间窗: One month after vaccination
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
次要结局
- Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination(One month after vaccination)