Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Seroconversion rate of neutralizing antibody
研究概览
简要总结
A randomized and blind clinical consistency study for three commercial batches of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV) for immunogenicity and safety evaluation.
详细描述
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.
A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.
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
- 2 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants of 2 months of age
- •The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
- •Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
- •Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
- •Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
- •Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
- •Axillary temperature ≤37℃
排除标准
- •Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
- •Patients with fever or acute disease.
- •Have thrombocytopenia or hemorrhagic diseases
- •Patients undergoing immunosuppressive therapy or immunodeficiency
- •Have uncontrolled epilepsy or other progressive neurological disorders
- •Other situations that the investigator consider as non-eligible
研究组 & 干预措施
Batch 1 of sIPV
The first commercial batch of sIPV
干预措施: sIPV batch 1 (Biological)
Batch 2 of sIPV
The second commercial batch of sIPV
干预措施: sIPV batch 2 (Biological)
Batch 3 of sIPV
The third commercial batch of sIPV
干预措施: sIPV batch 3 (Biological)
结局指标
主要结局
Seroconversion rate of neutralizing antibody
时间窗: 1 month after primary immunization
Blood samples were collected before and after immunization. Seroconversion rate of serum neutralizing antibody was determined. Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
Local and systemic adverse reactions
时间窗: Within 1 month after primary immunization
Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
次要结局
- GMT of neutralizing antibody(1 month after primary immunization)