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
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
- 是
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)
