Phase IV Clinical Trial of the ACYW135 Group Meningococcal Polysaccharide-Conjugated Vaccine (CRM197 Vector)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135
研究概览
简要总结
This study included 180 trial participants who had previously taken part in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and had completed blood sample collection at 90 and 180 days post-vaccination; there were 90 participants in each of the treatment and control groups. All trial participants were required to provide 3.0-4.0 mL of blood samples for immunopersistence assessment at 3 and 5 years post-vaccination, respectively.
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
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who previously participated in the Phase IIIb clinical trial of the ACYW135 group meningococcal polysaccharide-conjugated vaccine (CRM197 carrier) for children aged 4-6 years (Protocol No.: CTP-MCVF-002) and were included in both the IPS1 and IPS2 analysis sets
- •Willing to provide identification documents
- •Willing to provide informed consent, voluntarily sign the informed consent form, and comply with the requirements of the clinical study protocol
- •The interval since completion of the vaccination series must be at least 3 years
排除标准
- •Received another meningococcal vaccine after completion of the CTP-MCVF-002 trial
- •Has thrombocytopenia, any coagulation disorder, or is currently receiving anticoagulant therapy
- •Has a history of meningitis since the end of the CTP-MCVF-002 trial
- •Other conditions deemed by the investigator to make the subject ineligible for this clinical study
结局指标
主要结局
Geometric Mean Titers of Meningococcal Antibodies in Groups A, C, Y, and W135
时间窗: 3 and 5 Years After Vaccination
Positivity Rates of Meningococcal Antibodies in Groups A, C, Y, and W135
时间窗: 3 and 5 Years After Vaccination
次要结局
- Proportion of individuals with meningococcal antibody titers of ≥1:128 in serogroups A, C, Y, and W135(3 and 5 years after vaccination)