Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 10
- 主要终点
- Number of participants reporting immediate adverse events (AEs)
研究概览
简要总结
The primary objectives of this study are:
- To describe the safety profile of each of the investigational vaccine formulations for all participants
- To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
- To evaluate the dose response to vaccine components
- To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations
详细描述
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
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
- 19 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants reporting immediate adverse events (AEs)
时间窗: Within 30 minutes post-vaccination
AEs, including those related to the product administered
Number of participants reporting unsolicited AEs
时间窗: Within 30 days post-vaccination
AEs other than solicited reactions
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
时间窗: Within 60 days post-vaccination
Haematological and biochemical laboratory parameters
GMCs of anti-tetanus toxoid immunoglobulins
时间窗: From Day 0 to Day 360
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Number of participants reporting serious adverse events (SAEs)
时间窗: Up to 12 months post-vaccination
SAEs, including adverse event of special interest (AESIs)
Number of participants reporting medically attended adverse events (MAAEs)
时间窗: Up to 12 months post-vaccination
MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
时间窗: From Day 0 to Day 360
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Geometric means of antigen-specific cells
时间窗: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
Number of participants reporting solicited injection sites or systemic reactions
时间窗: Within 7 days post-vaccination
Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants reporting adverse events of special interest (AESIs)
时间窗: Up to 12 months post-vaccination
AESIs are reported until the end of the safety follow-up period
GMCs of anti-diphtheria toxoid immunoglobulins
时间窗: From Day 0 to Day 360
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Percentages of antigen-specific cells
时间窗: From Day 0 to Day 360
Antigen specific cells will be measured by FLUOROSPOT
次要结局
未报告次要终点