Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
研究概览
简要总结
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
详细描述
This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who completed the phase II Vi-DT study (Typhoid 0218)
- •Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
- •Subject/parents/legal guardians 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 ≥ 37.5oC).
- •Known history of allergy to any component of the vaccines.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
研究组 & 干预措施
Vi-DT Typhoid Conjugate Vaccine
Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.
干预措施: Vi-DT Typhoid Conjugate Vaccine (Drug)
结局指标
主要结局
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
时间窗: 2 years + 2 months after primary dose
Percentage of adults, adolescent, children and infants with seroconversion defined as \>= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.
次要结局
- To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.(3 years)
- To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.(28 days (-4/+14D))
- To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.(28 days (-4/+14D))
- To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.(5 years)