A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 1
- 主要终点
- Serious Adverse Events (SAE)
研究概览
简要总结
The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who have participated in the Phase III clinical study of Beijing Minhai PCV13 and have been fully vaccinated with Minhai PCV13;
- •An informed consent was required to sign by their legal guardians;
- •Volunteers and their legal guardians/caregivers were able to attend the study visit as required by the protocol.
排除标准
- •Those who had any administration history of pneumococcal polysaccharide or conjugate vaccine after participating in the Phase III clinical study;
- •Prior to enrollment, patients who had a history of pneumococcal infection with one or more of the well-defined PCV13 serotypes;
- •The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
研究组 & 干预措施
2 months group
干预措施: PCV13 (Biological)
2-5 years old group
干预措施: PCV13 (Biological)
12-23 months group
干预措施: PCV13 (Biological)
7-11 months group
干预措施: PCV13 (Biological)
结局指标
主要结局
Serious Adverse Events (SAE)
时间窗: one months to 12 months after the last injection
percentage of subjects reached the IgG level of ≥0.35 µg/mL
时间窗: 2-5 years after the first dose
evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group.
GMCs level for IgG antibody
时间窗: 2-5 years after the first dose
evaluation time: two years after the first dose for 2-5 years old group, two and three years after the first dose for 12-23 months group, two, three and four years after the first dose for 7-11 months group, two, three, four and five years after the first dose for 2 months group.
次要结局
未报告次要终点