A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
研究概览
简要总结
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults
- •Aged 65 to 85 years
排除标准
- •Proven or suspected prior episode of Clostridium difficile associated diarrhea
- •Unstable chronic medical condition
- •Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
- •Serious chronic medical disorders
- •Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
- •Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
- •Subjects with congenital or acquired immunodeficiency disorders
- •Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
- •Active or treated leukemia or lymphoma or bone marrow disorder
- •Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
- •Abnormality in screening hematology and/or blood chemistry laboratory values
研究组 & 干预措施
Placebo (accelerated schedule)
干预措施: Placebo (Biological)
Placebo (non-accelerated schedule)
干预措施: Placebo (Biological)
Low-dose C. difficile Vaccine (non-accelerated schedule)
干预措施: Clostridium difficile Vaccine (Biological)
High-dose C. difficile Vaccine (non-accelerated schedule)
干预措施: Clostridium difficile Vaccine (Biological)
Low-dose C. difficile Vaccine (accelerated schedule)
干预措施: Clostridium difficile Vaccine (Biological)
High-dose C. difficile Vaccine (accelerated schedule)
干预措施: Clostridium difficile Vaccine (Biological)
结局指标
主要结局
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
时间窗: From the first vaccination up to 28 days after the last vaccination
Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
时间窗: Up to 14 days after each vaccination
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
时间窗: From the first vaccination until 6 months after the last vaccination
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
时间窗: Up to 14 days after each vaccination
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
时间窗: 7 days or 14 days after each vaccination
次要结局
- Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels(Up to 6 months after dose 3)
- Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A(Up to 6 months after dose 3)
- Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B(Up to 6 months after dose 3)
- Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations(Up to 6 months after dose 3)
- Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels(Up to 6 months after dose 3)
- Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels(Up to 6 months after dose 3)
- Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels(Up to 6 months after dose 3)
- Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively(Up to 6 months after dose 3)