Phase I Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
研究概览
简要总结
This clinical trial will enroll 160 participants who previously took part in the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combination vaccine (for individuals aged 6 years and older) (Protocol No.: CTP-Tdcp-001). Approximately 3-4 mL of venous blood will be collected from each participant 2.5 years, 5 years, and 10 years after vaccination for a study on immune persistence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the 6-11-year-old, 12-17-year-old, and ≥18-year-old groups from the Phase I clinical trial of the adsorbed acellular pentavalent (five-component) DTP-polio combined vaccine (for individuals aged 6 and older) (Protocol No.: CTP-Tdcp-001) who were included in the protocol-defined analysis set;
- •Willingness to provide identification documents;
- •Informed consent must be obtained from the trial participant and/or guardian and/or authorized representative, and the informed consent form must be signed;
- •The trial participant and/or guardian and/or authorized representative must be able and willing to comply with the requirements of the clinical study protocol and be able to complete the full course of study follow-up.
排除标准
- •Received another DTP-type vaccine after completing the CTP-Tdcp-001 study;
- •Developed a DTP-related illness since the completion of the CTP-Tdcp-001 study;
- •Has a coagulation disorder;
- •In the investigator's judgment, the participant has any other factors that make them unsuitable for participation in the clinical trial.
结局指标
主要结局
Seropositivity rates of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
时间窗: 2.5, 5, and 10 years post-vaccination
Geometric mean concentrations (GMC) of antibodies against DT, TT, PT, FHA, PRN, and FIM 2&3
时间窗: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-PRN antibody levels ≥5 and ≥10 IU/mL
时间窗: 2.5, 5, and 10 years post-vaccination
Proportions of anti-FIM 2&3 antibody levels ≥5 and ≥10 EU/mL
时间窗: 2.5, 5, and 10 years post-vaccination
Proportions of serum anti-DT and anti-TT antibody levels ≥0.1 IU/mL and ≥1.0 IU/mL
时间窗: 2.5, 5, and 10 years post-vaccination
次要结局
未报告次要终点