Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
试验速览
- 阶段
- 1 期
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
研究概览
简要总结
The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.
详细描述
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety (solicited adverse events) of GC3111 in healthy adults.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged between 19 and 64 years at the time of vaccination
- •Informed consent and assent forms have been signed and dated
排除标准
- •Known or suspected receipt of any Tdap vaccine
- •Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- •Receipt of any vaccine within 30 days before receiving study vaccine
- •Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
结局指标
主要结局
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
时间窗: 28 days after Vaccination
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
时间窗: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
时间窗: 28 days after Vaccination
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
时间窗: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
次要结局
- Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine(Up to 30 minutes post-vaccination)