NCT05471531已完成4 期
Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 4
- 主要终点
- Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
研究概览
简要总结
This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.
详细描述
This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The elderly aged 60 and above;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form;
- •Proven legal identity.
排除标准
- •Received any circulating seasonal influenza vaccine prior to enrollment;
- •Have received any pneumococcal vaccine within 5 years;
- •History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
- •History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
- •Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
- •Receipt of other investigational drugs in the past 30 days;
- •Receipt of attenuated live vaccines in the past 14 days;
- •Receipt of inactivated or subunit vaccines in the past 7 days;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
结局指标
主要结局
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
时间窗: 28 days after combined vaccination
GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .
次要结局
- Safety index-incidence of adverse reactions(Within 7 days after combined immunization)
- Safety index-Incidence of adverse reactions(Within 28 days after combined immunization)
- Immunogenicity index of seropositivity rates of influenza HI antibodies(28 days after combined vaccination)
- Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody(28 days after combined vaccination)
- Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody(28 days after combined vaccination)
- Geometric mean titer(GMT) of influenza HI antibodies(28 days after a single injection of quadrivalent influenza vaccine)
- The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine(Within 28 days after a single injection of quadrivalent influenza vaccine)
- The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine(Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine)
- Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies(28 days after combined vaccination)
- Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody(28 days after combined vaccination)
- Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody(28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine)
- Immunogenicity index of the seroconversion rates of influenza HI antibodies(28 days after combined vaccination)
- Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine(Within 7 days after a single injection of quadrivalent influenza vaccine)
- Seroconversion rates of influenza HI antibodies(28 days after a single injection of quadrivalent influenza vaccine)
- Geometric Mean Increase (GMI) of influenza HI antibodies(28 days after a single injection of quadrivalent influenza vaccine)
- Seropositivity rates of influenza HI antibodies(28 days after a single injection of quadrivalent influenza vaccine)
- Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody(28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine)
- GMI for 23 serotypes specificity of pneumococcal IgG antibody(28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine)
- Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine(Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine)
研究者
研究点 (4)
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