Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- PT Bio Farma
- 入组人数
- 540
- 主要终点
- Protectivity
研究概览
简要总结
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
详细描述
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.
The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.
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
- Double (Participant, Investigator)
盲法说明
The subject will be randomized and vaccinated per treatment group by unblinded team.
The randomization list will be provided by unblinded personel of study team. This unblinded team will keep the list until Bio Farma formally issue the result of the study. Treatment will be allocated in accordance with a randomization list, so that to each randomization number, corresponds only one strictly randomly assigned treatment group (A/B/C/D).
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individual aged 10 - 50 years old, 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 >= 37.5 C) 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 immunosuppressant.
- •Pregnancy & Lactation (Adult).
- •Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
研究组 & 干预措施
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
干预措施: In-House Recombinant Hepatitis B (Bio Farma) vaccine (Biological)
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
干预措施: In-House Recombinant Hepatitis B (Bio Farma) vaccine (Biological)
In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3
3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine
干预措施: In-House Recombinant Hepatitis B (Bio Farma) vaccine (Biological)
Registered Hepatitis B vaccine recombinant (Engerix-B)
3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)
干预措施: Registered Hepatitis B vaccine recombinant (Engerix-B) (Biological)
结局指标
主要结局
Protectivity
时间窗: 28 days after the primary series of Hepatitis B vaccination
Number \& percentage of subjects with anti HBsAg \> 10mIU/ml
次要结局
- Immunogenicity: Serological response(28 days after the primary series of Hepatitis B vaccination)
- Immunogenicity: comparison between IP & control(28 days after the primary series of Hepatitis B vaccination)
- Immunogenicity: comparison among each batch of IP(28 days after the primary series of Hepatitis B vaccination)
- Safety: Immediate reaction, Local and systemic events(within the first 30 minutes, after 30 minutes to 7 days, after 7 days to 28 days after each injection)
- Safety: Serious adverse event(from inclusion until 28 days after the last injection)
- Safety: Comparison of adverse events between Investigational Products (Hepatitis B) and Control(28 days after each dose)
- Safety: Comparison of adverse events between each lot number of Recombinant Hepatitis B(28 days after each dose)