A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and 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
- Local reaction and systemic event after vaccination
研究概览
简要总结
This study is to assess the safety of Vi-DT vaccine in adults and children.
详细描述
To describe the safety of this vaccine following first and second dose immunization.
To assess preliminary information of immunogenicity following Vi-DT vaccine 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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- •Subject/Parents 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
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
- •Known history of allergy to any component of the vaccines
- •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 long term corticotherapy (> 2 weeks).
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- •Pregnancy & lactation (Adults)
- •Individuals who have previously received any vaccines against typhoid fever.
- •Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
- •Individuals who have a previously ascertained typhoid fever.
- •History of alcohol or substance abuse.
- •Subject planning to move from the study area before the end of study period.
研究组 & 干预措施
Vi-DT (Bio Farma)
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
干预措施: Vi-DT (Bio Farma) (Biological)
Vi polysaccharide vaccine
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine
干预措施: Vi polysaccharide vaccine (Biological)
Vi polysaccharide vaccine
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine
干预措施: Influenzae vaccine (Biological)
Vi-DT (Bio Farma) ~ Children
2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
干预措施: Vi-DT (Bio Farma) (Biological)
Vi polysaccharide vaccine ~ Children
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine
干预措施: Vi polysaccharide vaccine (Biological)
Vi polysaccharide vaccine ~ Children
1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine
干预措施: Pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
Local reaction and systemic event after vaccination
时间窗: 28 days
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
次要结局
- Adverse events after vaccination(28 days)
- Serious adverse events after vaccination(28 days)
- Routine laboratory evaluation that probably related to the vaccination.(7 days)
- Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)(28 days)
- Geometric Mean Titers (GMT) following immunization(28 days)