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临床试验/NCT05119426
NCT05119426招募中4 期

An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 2: Typhoid Conjugate Vaccine (TCV) Mass-vaccination Campaign

International Vaccine Institute25 个研究点 分布在 1 个国家目标入组 48,000 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
48,000
试验地点
25
主要终点
Direct vaccine effectiveness of Typbar-TCV®

研究概览

简要总结

This is a prospective cohort evaluation of vaccine effectiveness of a single dose of Typbar-TCV® against symptomatic blood culture-confirmed typhoid fever when administered through a mass vaccination campaign to children 9 months to <16 years of age in Kisantu, DRC.

详细描述

This study is conducted in Kisantu, DRC and is comprised of a mass vaccination campaign of children aged 9 months to <16 years with a single dose of Typbar-TCV® and a concomitant surveillance study to assess the incidence of culture-confirmed typhoid fever in the population during a period of three years following vaccination. Safety events will be monitored for 30 minutes following vaccination for all participants. In a subset of age-eligible participants living in the study area, the investigators will assess local and systemic solicited adverse events/adverse reactions and unsolicited adverse events occurring within the first 7 days post-vaccination and unsolicited and serious adverse events within 28 days post-vaccination. A population census will be conducted at baseline to enumerate and characterize the population under study and demographic information will be collected to allow for minimization of potential sources of bias during analysis. An interim censuses and a census at study closure will be carried out to update population information.

The investigators hypothesize that the Typbar-TCV® vaccine is effective in large scale vaccination campaigns, thereby lowering the incidence of blood-culture confirmed typhoid fever in children. Lessons and experiences on vaccination feasibility and uptake will be important for informing TCV introduction across the African continent.

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
9 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent/guardian willing and able to provide informed consent; assent will be sought for participants between 12 and <16 years of age
  • Resident of the defined study area, Kisantu Health Zone at the time of vaccination
  • Age between 9 months and <16 years (i.e., ≤15 years and 364 days) on the day of vaccination

排除标准

  • The participant has a known allergy to any of the vaccine components,
  • Any medical reason perceived to increase risk to health posed by vaccination as judged by a medical professional
  • Self-reported pregnancy in females greater or equal to 11 years of age who have reported menarche

结局指标

主要结局

Direct vaccine effectiveness of Typbar-TCV®

时间窗: 3 years

Comparison of incidence of blood culture confirmed Salmonella Typhi infection in participants 9 months to \<16 years of age vaccinated with a single dose of Typbar-TCV® delivered through a mass vaccination campaign and unvaccinated participants 9 months to \<16 years of ageSalmonella Typhi isolated from blood specimens using conventional microbiological techniques

次要结局

  • Safety profile of Typbar-TCV®(28 days)
  • Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC(3 years)
  • Overall vaccine effectiveness of Typbar-TCV®(3 years)
  • Total vaccine effectiveness of Typbar-TCV®(3 years)
  • Indirect vaccine effectiveness of Typbar-TCV®(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (25)

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