A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains （Hereinafter as "sIPV") From Different Manufacturers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse reaction incidence
研究概览
简要总结
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
详细描述
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Healthy infants of ≤ 12 months of age;
- •(2) Can provide proof of legal identity;
- •(3) Have completed two doses of sIPV vaccination at Beijing Institute;
- •(4) Able to provide proof of sIPV vaccination;
- •(5) The participant's guardian can understand and agree to sign the informed consent form.
排除标准
- •(1) Known severe allergy to vaccines or vaccine components, such as urticaria, dyspnea, angioneurotic edema;
- •(2) Received immunoglobulins or other blood products, or plan to receive such treatment during the study;
- •(3) Received ≥14 days of immunosuppressive or other immunomodulatory therapy or cytotoxic therapy, or plan to receive such therapy during the study;
- •(4) Received another investigational vaccine within 28 days before receiving the study vaccine;
- •(5) Received a live attenuated vaccine within 14 days before receiving the trial vaccine;
- •(6) Received a subunit or inactivated vaccine within 7 days before receiving the trial vaccine;
- •(7) Acute exacerbation of various acute illnesses or chronic diseases within the last 7 days;
- •(8) Those who had a fever with an axillary temperature >37.0°C before receiving the study vaccine;
- •(9) Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in the study.
研究组 & 干预措施
experimental group
sIPV: Sinovac Biotech Co., Ltd., Beijing
干预措施: sIPV (Biological)
control group
sIPV: Beijing Institute of Biological Products Co., LTD.
干预措施: sIPV (Biological)
结局指标
主要结局
Adverse reaction incidence
时间窗: 30 days
-The incidence of adverse reaction within 30 days after vaccination;
Geometric Mean Increase (GMI)
时间窗: 30 days
-The neutralizing antibody GMI against different types (Type I, II and III) at day 30 after vaccination;
Geometric Mean Titer (GMT)
时间窗: 30 days
-The neutralizing antibody GMT against different types (Type I, II and III) at day 30 after vaccination;
Seropositivity rate
时间窗: 30 days
-The seropositivity rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Seroconversion rate
时间窗: 30 days
-The seroconversion rate of neutralizing antibody against different types (Type I, II and III) at day 30 after vaccination;
Serious adverse events incidence
时间窗: 30 days
-The incidence of serious adverse events within 30 days after vaccination.
次要结局
未报告次要终点