NCT07071701已完成不适用
A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population Aged 2 Years and Above
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,267
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
研究概览
简要总结
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
- •Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
- •Provide valid legal identification.
排除标准
- 未提供
研究组 & 干预措施
Passive safety surveillance group
干预措施: Influenza vaccine (Biological)
Passive safety surveillance group
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
Acitive safety surveillance group
干预措施: 23-valent pneumococcal polysaccharide vaccine (Biological)
Acitive safety surveillance group
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Incidence of adverse reactions to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.
时间窗: 28 days after the vaccination
次要结局
- Incidence of adverse events to 23-valent pneumonia vaccine within 0-28 days after single and combined vaccination.(28 days after the vaccination)
- Incidence of adverse events to 23-valent pneumonia vaccine within 0-7 days after single and combined vaccination.(7 days after the vaccination)
研究者
研究点 (1)
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