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临床试验/NCT06921460
NCT06921460尚未招募不适用

Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population Compared to PQed TCV

PT Bio Farma1 个研究点 分布在 1 个国家目标入组 624 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
PT Bio Farma
入组人数
624
试验地点
1
主要终点
To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)

研究概览

简要总结

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.

详细描述

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Data mainly from Asia, Africa and Latin America show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. In some endemic areas, children aged < 5 years show incidence rates similar to, or exceeding those, of school age children. WHO conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. An estimated 90% of these deaths occur in Asia. Increasing multidrug resistance of S. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths.

This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I. During the research, participants will make one (1) research visit to the health center for examination and blood sampling. After 5 years of being given the Typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. The research team will ask questions about the willingness to participate in the research. If they agree, a visit will be scheduled to the research site. This research is conducted by the Department of Pediatrics, Cipto Mangunkusumo Hospital, Jakarta, Dr. Soetomo Hospital, Surabaya and PT Bio Farma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

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

  • History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

结局指标

主要结局

To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)

时间窗: 5 years since got vaccination

次要结局

未报告次要终点

研究者

发起方
PT Bio Farma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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