NCT03919578已完成2 期
Protectivity and Safety Following Recombinant Hepatitis B Vaccine With Different Source of Hepatitis B Bulk Compared to Hepatitis B (Bio Farma) Vaccine in Indonesian Population
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Percentage of subjects with increasing antibody titer >= 4 times
研究概览
简要总结
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
详细描述
Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population.
Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.
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)
盲法说明
Investigational product was masking with control
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individu as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.
- •Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
- •Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •Subjects with known history of Hepatitis B contained vaccination in the last 10 years
- •Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
- •Known history of allergy to any component of the vaccines (based on anamnesis)
- •HBsAg positive
- •Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant.
- •Pregnancy & Lactation (Adult)
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
结局指标
主要结局
Percentage of subjects with increasing antibody titer >= 4 times
时间窗: 28 days after the last dose immunization
Percentage of subjects with increasing antibody titer \>= 4 times: in all subjects; comparison between investigational product and control and between each lot number of Recombinant Hepatitis B
次要结局
- Percentage of subjects with at least one immediate reaction(30 minutes after each vaccination)
- Percentage of subjects with at least one of these adverse events(within 72 hours, between 72 hours to 28 days after vaccination)
- Geometric Mean Titer (GMT)(28 days after the last dose immunization)
- Percentage of subjects with transition of seronegative to seropositive(28 days after the last dose immunization)
- Serious adverse event after vaccination(28 days after the last dose immunization)
- Comparison adverse events between Investigational Products (Hepatitis B) and Control(28 days after each dose)
- Comparison of adverse events between each lot number of Recombinant Hepatitis B vaccine(28 days after each dose)
研究者
研究点 (1)
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