Phase IV Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants
研究概览
简要总结
This clinical study will enroll 100 participants from the 2-month-old (minimum 6 weeks) group who previously participated in the Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV), with 50 participants in each of the treatment and control groups, and who have completed blood sample collection for the 1-year and 2-year immunogenicity studies. All participants will have 3.0-3.5 mL of venous blood collected for the immunogenicity study.
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
- 5 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the 2-month-old (minimum 6 weeks) group from the previous Phase III clinical trial of the 13-valent pneumococcal polysaccharide conjugate vaccine (CRM197, TT vector) (Protocol No.: CS-CTP-PCV)
- •The legal guardian or authorized representative is willing to provide identification documents
- •The legal guardian or authorized representative has provided informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol
- •The interval since the last dose of the primary vaccination series is ≥4 years
排除标准
- •Failure to complete blood draws at 1 and 2 years post-vaccination
- •Administration of any pneumonia vaccine after completion of the full vaccination series
- •Body temperature ≥37.3°C
- •Any other factors deemed by the investigator to render the participant unsuitable for participation in the clinical trial
研究组 & 干预措施
Previously vaccinated with PCV13 (CanSino)
干预措施: Previously vaccinated with PCV13 (CanSino) (Other)
Previously vaccinated with PCV13 (Pfizer)
干预措施: Previously vaccinated with PCV13 (Pfizer) (Other)
结局指标
主要结局
Seropositivity rate for serotype-specific pneumococcal IgG antibodies (antibody concentration ≥ 0.35 μg/ml) among trial participants
时间窗: 4 years after completion of the full vaccination series
Geometric mean concentration (GMC) of antibodies among trial participants
时间窗: 4 years after completion of the full vaccination series
次要结局
- Proportion of trial participants with serum-type-specific pneumococcal IgG antibody among trial participants(4 years after completion of the full vaccination series)