Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children (Phase I)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of subjects with Immediate reaction
研究概览
简要总结
This trial is an experimental, randomized, double blind, prospective intervention study
Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:
For adult (18-40 years old)
详细描述
Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind.
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, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator.
- •Subjects have been informed properly regarding the study and signed the informed consent form
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
- •Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax 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 and
- •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
- •Any direct relatives relationship with the study team.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
- •Known history of allergy to any component of the vaccines (based on anamnesis)
- •Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
- •History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
- •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).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults)
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
- •HbsAg positive
- •Subjects with known history of Hepatitis B infection.
- •Subjects who have received Hepatitis B vaccination which proven by vaccination records.
- •Subject planning to move from the study area before the end of study period.
结局指标
主要结局
Number of subjects with Immediate reaction
时间窗: 3 months
Number of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
percentage of subjects with Immediate reaction
时间窗: 3 months
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatits B vaccination
次要结局
- Percentage of subjects with Adverse Events from 1 day to 28 days after vaccination(3 months)
- Number of subjects with Adverse Events from 1 day to 28 days after vaccination(3 months)
- Protectivity of Hepatitis B vaccine (number of subject with protective anti HbsAg)(3 months)
- Percentage of subjects with serious Adverse Events from 1 day to 28 days after vaccination(3 Months)
- Protectivity of Hepatitis B vaccine (Geometic Mean Titers)(3 months)
- Number of subjects with Serious Adverse Events from 1 day to 28 days after vaccination(3 Months)
- Number of Lab Deviation for adults subjects in 7 days of immunization(7 Days After 1st Vaccination)
- Safety Comparison between each intervention group(3 months)
- Protectivity of Hepatitis B vaccine (4 times increasing antibody)(3 months)
- Anti-HBs description between groups(3 months)