A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCRs) of each group after primary immunization.
研究概览
简要总结
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
详细描述
The study is a randomized, double-blind, controlled randomized, double-blind, controlled clinical trial clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) manufactured by Sinovac Vaccine Technology Co., Ltd in 2-month-old infants. The control vaccine is a commercialized Inactivated Poliovirus Vaccine manufactured by Sanofi Pasteur company. 1200 healthy infants between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1.
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)
入排标准
- 年龄范围
- 60 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 60-90 days old;
- •Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- •Proven legal identity;
- •Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- •Complying with the requirement of the study protocol;
排除标准
- •Prior vaccination with Poliovirus Vaccine;
- •History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- •Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- •Autoimmune disease or immunodeficiency/immunosuppressive;
- •Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- •Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
- •Blood product prior to study entry;
- •Any other investigational medicine(s) within 30 days prior to study entry;
- •Any live attenuated vaccine within 14 days prior to study entry;
- •Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Axillary temperature > 37.0 °C;
- •Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
研究组 & 干预措施
Experimental Group
The investigational vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
Intervention: investigational sIPV
干预措施: Investigational sIPV (Biological)
Control Group
The control vaccine was manufactured by Sanofi Pasteur Company. Intervention: control IPV
干预措施: Control IPV (Biological)
结局指标
主要结局
The seroconversion rates (SCRs) of each group after primary immunization.
时间窗: 90 days
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
次要结局
- The incidences of unsolicited adverse events (AEs) of each group.(30 days)
- The incidence of serious adverse events (SAEs) during the period of safety monitoring of each group.(90-420 days.)
- The percentage of subjects with antibody ≥ 1:64 of each group before booster dose.(420 days)
- The post-immune antibody positive rate of each group after booster dose.(570 days)
- The percentage of subjects with antibody ≥ 1:64 of each group after primary immunization.(90 days)
- The incidences of solicited adverse events (AEs) of each group.(7 days)
- The post-immune antibody positive rate of each group after primary immunization.(90 days)
- The post-immune geometric mean titer (GMT) of each group after primary immunization.(90 days.)
- The geometric mean fold increase (GMI) of each group after primary immunization.(90 days)
- The geometric mean fold increase (GMI) of each group before booster dose.(420 days)
- The antibody positive rate of each group before booster dose.(420 days)
- The geometric mean titer (GMT) of each group before booster dose.(420 days.)
- The post-immune geometric mean titer (GMT) of each group after booster dose.(570 days)
- The geometric mean fold increase (GMI) of each group after booster dose.(570 days)
- The percentage of subjecs with antibody ≥ 1:64 of each group after booster dose.(570 days)