A Randomized, Blinded and Controlled Phase II Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Infants.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The seroconversion rates (SCRs) of each group after three-dose regimen
研究概览
简要总结
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
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
- 60 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer aged 2 months (60~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
- •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;
- •Axillary temperature ≤ 37.0 °C;
排除标准
- •Preterm or low birth weight infants;
- •Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- •History of polio;
- •Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •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;
- •Autoimmune disease or immunodeficiency/immunosuppressive;
- •Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- •Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
- •Mother of the participant has HIV infection;
- •Acute illness or acute exacerbation of chronic disease within the past 7 days;
- •Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
- •Receipt of any subunit or inactivated vaccine within the past 7 day;
- •Receipt of any live attenuated vaccine within the past 14 days;
- •Receipt of any blood product within the past 3 months;
- •Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
研究组 & 干预措施
Experimental Group - Low dosage
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
干预措施: Three-dose regimen of low dosage investigational sIPV (Biological)
Experimental Group - High dosage
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
干预措施: Three-dose regimen of high dosage investigational sIPV (Biological)
Experimental Group - Medium dosage
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
干预措施: Three-dose regimen of medium dosage investigational sIPV (Biological)
Control Group -commercialized sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV
干预措施: Three-dose regimen of commercialized sIPV (Biological)
Control Group -commercialized IPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV
干预措施: Three-dose regimen of commercialized IPV (Biological)
结局指标
主要结局
The seroconversion rates (SCRs) of each group after three-dose regimen
时间窗: 28~42 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.
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
时间窗: 28~42 days
GMT of each group 28\~42 days after three-dose regimen.
The geometric mean fold increase (GMI) of each group after three-dose regimen
时间窗: 28~42 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
次要结局
- The incidences of solicited adverse events (AEs) of each group(7 days)
- The incidences of unsolicited adverse events (AEs) of each group(30 days)
- The incidences of serious adverse events (SAEs) of each group(30 days)