Assessment of Chikungunya Virus Seroprevalence Before VLA1553 Vaccination in the Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,354
- 试验地点
- 4
- 主要终点
- To prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) after implementing a pilot vaccination in the age-group approved per label.
研究概览
简要总结
This is a cross-sectional serosurvey using household cluster sampling conducted before the VLA1553 pilot vaccination strategy will be implemented in about 10 municipalities in Brazil.
详细描述
Households will be selected randomly using a multi-stage random sampling at the census tract, street, and household levels, to select study participants. The study aims to prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) in the age-group approved per label in Brazil (e.g., adults [≥18 years of age] or individuals ≥12 years of age). Seroprevalence among vaccinated and unvaccinated individuals will be used to parameterize a probabilistic bias analysis conducted as part of the VE study. Finally, the study will explore the prevalence of CHIKV exposure in the different study communities before the VLA1553 pilot vaccination strategy in individuals ≥2 years of age.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals residing in the selected municipalities of Brazil where the VLA1553 pilot vaccination strategy will be implemented.
- •Individuals ≥2 years of age
- •Individuals who sleep 3 nights a week or more in a household that is selected by cluster sampling.
排除标准
- •1. Individuals or their legally accepted representatives (LAR) who are not willing or not able to provide informed consent (and assent, as required) according to country-specific procedures.
结局指标
主要结局
To prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) after implementing a pilot vaccination in the age-group approved per label.
时间窗: on Day 1
次要结局
未报告次要终点