A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Immunogenicity index-Seroconversion rate (2-fold increase rate)
研究概览
简要总结
This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.
详细描述
This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp & Dohme.A total of 1800 subjects including 900 subjects aged 2~17 years,360 subjects aged 18~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.
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
- Single (Participant)
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
- •Children aged 2 years and above in stable health;
- •The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
- •Proven legal identity.
排除标准
- •Have received any pneumococcal vaccine;
- •History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture.
- •Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- •History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- •Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •A long history of alcohol or drug abuse;
- •Receipt of blood products within in the past 3 months;
- •Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
- •Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
- •Receipt of inactivated or subunit vaccines in the past 7 days;
- •Onset of various acute or chronic diseases within 3 days prior to the study;
- •Underarm body temperature before vaccination>37.0°C;
- •The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
研究组 & 干预措施
Experimental Group
1200 participants(including 600 subjects aged 2~17 years,240 subjects aged 18~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd
干预措施: Experimental 23-valent PPV (Biological)
Control Group
600 participants(including 300 subjects aged 2~17 years,120 subjects aged 18~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp & Dohme.
干预措施: Control 23-valent PPV (Biological)
结局指标
主要结局
Immunogenicity index-Seroconversion rate (2-fold increase rate)
时间窗: 30 days after vaccination
Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
次要结局
- Safety index-incidence of adverse reactions(Within 7 days after vaccination)
- Immunogenicity index-Seroconversion rate(30 days after vaccination)
- Immunogenicity index-GMC(30 days after vaccination)
- Immunogenicity index-GMI(30 days after vaccination)
- Immunogenicity index-Geometric Mean Concentration (GMC)(30 days after vaccination)
- Immunogenicity index-Geometric Mean Increase (GMI)(30 days after vaccination)
- Safety index-Incidence of adverse reactions(Within 30 days after vaccination)
- Safety index-Incidence of serious adverse events(Within 30 days after vaccination)