Prospective Safety Cohort Study VLA1553-406
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- To estimate the incidence rates of a predefined set of AEs which constitute safety concerns according to the VLA1553 Risk Management Plan following the administration of the live-attenuated VLA1553 vaccine
研究概览
简要总结
This is an observational study with primary data collection, which will combine a prospective safety cohort study and an SCRI study.
详细描述
This prospective safety cohort study will be conducted in selected Brazilian municipalities participating in a pilot vaccination strategy. A total of 5,000 participants will be recruited. The primary objective is to estimate the incidence rates of a predefined set of AEs which constitute safety concerns. The secondary objectives are to measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns, and to assess the frequency of occurrence of any collected AE which are medically attended or meet the criteria of seriousness This study also aims to investigate VLA1553's safety in underrepresented populations by collecting all AEs, not just AEs which constitute safety concerns.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants who received a single dose of VLA1553 at a vaccination unit while participating in the pilot vaccination strategy.
- •Individuals that are target for the pilot vaccination strategy at the time of vaccination.
- •Individuals understanding and being able to comply with all scheduled follow-up calls/contacts and study procedures.
- •Have given informed consent/assent prior to entering the study.
排除标准
- •Individuals who have received investigational products within the 30 days prior to VLA1553 vaccination, or individuals who have received VLA1553/IXCHIQ previously or any authorized or approved CHIKV vaccine.
- •Individuals who are not expected to remain available for the study follow-up for the next 24 weeks after vaccination.
- •Pregnant women: women exposed to VLA1553 anytime during their pregnancy or within 30 days preceding their last menstrual period will be invited to participate in a separate pregnancy surveillance study (study identifier VLA1553-403).
结局指标
主要结局
To estimate the incidence rates of a predefined set of AEs which constitute safety concerns according to the VLA1553 Risk Management Plan following the administration of the live-attenuated VLA1553 vaccine
时间窗: From enrollment until Day 60
For each safety concern, the risk windows after VLA1553 administration are defined as: 1. 30 days for Chikungunya-like adverse reactions; 2. 60 days for cardiac events, choosing a more conservative window than the 42 days suggested by the Brighton Collaboration recommendations on myocarditis; 3. 60 days for arthritis to account for late-onset or potentially immune-mediated cases
次要结局
- To measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns as per the VLA1553 Risk Management Plan for those AEs that have a defined risk window following vaccination.(From enrollment until Day 120)
- To assess the frequency of occurrence of predefined AEs which are medically attended or meet the criteria of seriousness.(From enrollment until Month 6)