A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Controlled Phase to Evaluate the Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,572
- 试验地点
- 2
- 主要终点
- Safety index-incidence of adverse reactions
研究概览
简要总结
This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.
详细描述
This study includes two stages. A clinical trial with an open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses) (hereinafter referred to as "msIPV") in adults, children and infants in stageⅠ and a blinded, randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in stage Ⅱ. A total of 1572 subjects including 24 adults aged 18-49 years,24 children aged 4 years,1524 infants aged 2 months will be enrolled.
StagesⅠ:72 healthy subjects, including 24 adults,24 children and 24 infants will be enrolled. 24 adults and 24 children will receive one dose of vaccine and 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
StagesⅡ:1500 infants aged 2 months will be randomly divided into 5 groups (Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3,IPV control group and single-dose sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3 experimental groups will receive 5-dose sIPV produced by Sinovac for three lots, subjects in IPV control group will receive IPV produced by Pasteur, and subjects in single-dose sIPV control group will receive single-dose sIPV produced by Sinovac. All subjects will receive 4 doses of experimental or control vaccine according to the primary immunization schedule of 0,1,2 months, one dose of booster at 18 months of age.
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
- Double (Participant, Investigator)
盲法说明
The clinical trial is divided into two stages: the first stage is an open design, and the second stage is a randomized ,blind control design
入排标准
- 年龄范围
- 2 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for adult subjects :
- •Healthy adults aged 18-49 days;
- •Proven legal identification;
- •The subject can understand and voluntarily sign the informed consent form.
- •Inclusion criteria for children subjects :
- •Healthy children aged 4 years old;
- •Subjects who have completed primary immunization with 3 doses of sIPV vaccine;
- •Proven legal identification and vaccination certificate;
- •The subject and/or guardian can understand and voluntarily sign the informed consent form.
- •Inclusion criteria for infant subjects:
- •Healthy infants aged 2 months (60~89 days)
- •Proven legal identification and vaccination certificate;
- •The subject and/or guardian can understand and voluntarily sign the informed consent form.
排除标准
- •Exclusion criteria for adult subjects:
- •Women aged 18 to 49 years, positive urine pregnancy test, pregnant women, breastfeeding women, or planning to become pregnant within 3 months;
- •Previous history of vaccination of sIPV vaccine;
- •Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- •Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- •Autoimmune disease or immunodeficiency/immunosuppression;
- •Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
- •Serious chronic diseases, serious cardiovascular diseases, hypertension that cannot be controlled by drugs (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg), diabetes, liver and kidney diseases, malignant tumors, etc;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •History of alcohol or drug abuse;
- •Receipt of blood products within in the past 3 months;
- •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;
- •Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- •Axillary temperature >37.0°C;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
- •Exclusion criteria for children subjects:
- •Have received 4 doses of sIPV vaccine;
- •History of polio;
- •Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- •Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- •Autoimmune disease or immunodeficiency/immunosuppression;
- •Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
- •Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
- •Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- •History of alcohol or drug abuse;
- •Receipt of blood products within in the past 3 months;
- •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;
- •Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- •Axillary temperature >37.0°C;
- •According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
- •Exclusion criteria for infant subjects:
- •Previous history of vaccination of sIPV vaccine;
- •History of polio;
- •Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
- •Preterm birth babies (delivered before 37 weeks gestation), low birth weight (girls with birth weight <2300g, boy with birth weight<2500 g);
- •History of dystocia, asphyxia and nervous system damage at birth;
- •Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
- •Autoimmune disease or immunodeficiency/immunosuppression;
- •Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
- •-Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
- •Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- •Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
- 另有 8 项未显示
结局指标
主要结局
Safety index-incidence of adverse reactions
时间窗: Within 30 days after each dose
Incidence of adverse reactions within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT)
时间窗: 30 days after primary immunization
GMT 30 days after primary immunization in msIPV vaccination group
Immunogenicity index- seroconversion rate of neutralizing antibody
时间窗: 30 days after primary immunization
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
次要结局
- Safety index-incidence of adverse reactions(Within 7 days after each dose)
- Safety index-the incidence of adverse reactions(During the period of safety monitoring)
- Immunogenicity index- Neutralizing antibody positive rate(Before booster dose)
- Immunogenicity index- Neutralizing antibody positive rate and GMI(30 days after primary immunization)
- Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI(30 days after booster dose)