Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: a Multicentre, Randomised, Controlled, Phase 4 Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Seroconversion rate against IIV4
研究概览
简要总结
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
详细描述
Participants aged ≥18 undergoing hemodialysis were recruited and randomly assigned to one of three study groups.
Experimental Group : The participants received the first dose of BBIBP-Corv and IIV4 simultaneously on Day 0, and received the second dose of BBIBP-Corv and PPV23 simultaneously on Day 28.
Control Group 1: The participants received two doses of BBIBP-Corv on Day 0 and Day 28, respectively.
Control Group 2 : The participants received one doses of IIV4 on Day 0 and received one doses of PPV23 on Day 28.
Three blood samples were collected on days 0, 28 and 56 to test humoral immunity, and three blood samples were collected on days 0, 42 and 56 to test cellular immunity to SARS-CoV-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Seroconversion rate against IIV4
时间窗: 28 days after vaccination (Day 28)
The rate of seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate against PPV23
时间窗: 28 days after vaccination (Day 56)
The rate of seroconversion against 23 pneumococcal serotypes
Neutralizing antibody GMT against SARS-CoV-2
时间窗: 28 days after two doses vaccination (Day 56)
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMT against IIV4
时间窗: 28 days after vaccination (Day 28)
Hemmagglution inhibition antibody GMT against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMC against PPV23
时间窗: 28 days after vaccination (Day 56)
IgG antibody GMC against 23 pneumococcal serotypes
Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2
时间窗: 28 days after two doses vaccination (Day 56)
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMI against IIV4
时间窗: 28 days after vaccination (Day 28)
Hemmagglution inhibition antibody GMI against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMI against PPV23
时间窗: 28 days after vaccination (Day 56)
IgG antibody GMI against 23 pneumococcal serotypes
Seroconversion rate against SARS-CoV-2
时间窗: 28 days after two doses vaccination (Day 56)
The rate of seroconversion against SARS-CoV-2
次要结局
- Adverse events rate(0-7 days or 0-28 days following vaccinations)
- Serious adverse event rate(0-6 months)