Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 3,071
- 试验地点
- 1
- 主要终点
- Immunogenicity
研究概览
简要总结
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
详细描述
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine.
Involved participants aged 6 months old to 60 years old.
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
Investigational Product and Active Comparator was masking Number of lot was masking
入排标准
- 年龄范围
- 6 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
- •Subject/parents/legal 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.
- •Evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary 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, corticosteroid therapy and other immunosuppressants)
- •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 vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine.
- •Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time.
- •Subject planning to move from the study area before the end of study period.
研究组 & 干预措施
Vi-DT TCV Batch 2
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2
干预措施: Vi-DT Typhoid Conjugate Vaccine (Biological)
Vi-DT TCV Batch 3
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3
干预措施: Vi-DT Typhoid Conjugate Vaccine (Biological)
PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)
1 dose of 0.5 ml of PQed TCV Vaccine
干预措施: PQed Typhoid Conjugate Vaccine (Biological)
Vi Polysaccharide Vaccine (subjects 46-60 years old)
1 dose of 0.5 ml of Vi Polysaccharide Vaccine
干预措施: Vi Polysaccharide Vaccine (Biological)
Vi-DT TCV Batch 1
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1
干预措施: Vi-DT Typhoid Conjugate Vaccine (Biological)
结局指标
主要结局
Immunogenicity
时间窗: 28 days
Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.
次要结局
- Describe antibody response following vaccination(28 days)
- Adverse event, solicited or unsolicited(28 days)
- Comparison the safety and immunogenicity(28 days)