A PHASE 1B, RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINES IN HEALTHY JAPANESE ADULTS 18 TO 49 YEARS OF AGE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 104
- 试验地点
- 7
- 主要终点
- Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
研究概览
简要总结
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or interview)
排除标准
- •Participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
研究组 & 干预措施
multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 1
干预措施: multivalent pneumococcal conjugate formulation 1 (Biological)
multivalent pneumococcal conjugate formulation 2
multivalent pneumococcal conjugate formulation 2
干预措施: multivalent pneumococcal conjugate formulation 2 (Biological)
Prevnar 13
13 valent Pneumococcal Conjugate
干预措施: Prevnar 13 (Biological)
结局指标
主要结局
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
时间窗: 14 days after vaccination
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
时间窗: 6 months after vaccination
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
时间窗: 6 months after vaccination
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
时间窗: 14 days after vaccination
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
Subjects reporting adverse events (AEs) within 1 month after vaccination.
时间窗: 1 month after vaccination
Subjects reporting adverse events (AEs) within 1 month after vaccination.
次要结局
- Immunogenicity(1 month after vaccination)