Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,309
- 试验地点
- 1
- 主要终点
- Assessment of the incidence of serious events in subjects vaccinated against CORONAVIRUS compared to those not vaccinated using their number, percentage and 95% confidence interval and methods of survival analysis Kaplan Meier and Cox model
研究概览
简要总结
The main objective of this non-interventional, multi-center study is to compare the incidence of serious health events (death, unscheduled hospitalizations) in subjects vaccinated against Coronavirus with that of unvaccinated subjects, in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-De-France during the same observation period 12-months minimun and up to18 months according vaccinal schedule.
The primary outcome will be the incidence of serious health events (death and unscheduled hospitalizations) in subjects vaccinated against Coronavirus compared to that of unvaccinated subjects.
详细描述
This multicenter study is a parallel cohort to the first phase of the vaccination campaign against Coronavirus, in particular for elderly subjects in institutions. All subjects who will not oppose the study will be included and this date will correspond to Day 0.
D0 will correspond to the date of the first vaccine injection for subjects in the vaccine group.
The subjects included will be followed up on D21, D90, M6, 12 months (M12) and up to 18 months in the case of 3rd vaccinal injection
The following data will be collected at inclusion and during follow-up:
- Age, weight, sex, level of autonomy
- Chronic diseases
- Any hospitalizations
- Possible symptoms after vaccination for subjects who choose to be vaccinated
- The fate of the subjects and the evaluation of the immune response
- Hospitalizations and vital status of subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject in Retirement Home (EHPAD) or Long-term Care Units (USLD) during the anti-Coronavivus vaccination period.
- •Subject not opposing the study or whose legal representative does not oppose the study.
排除标准
- •Subject not affiliated to a social security scheme.
研究组 & 干预措施
vaccinated group
unvaccinated group
结局指标
主要结局
Assessment of the incidence of serious events in subjects vaccinated against CORONAVIRUS compared to those not vaccinated using their number, percentage and 95% confidence interval and methods of survival analysis Kaplan Meier and Cox model
时间窗: 12 months or 18 months in the case of the 3rd vaccinal injection
次要结局
- Assessment of the incidence of geriatric syndromes using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model(3 months)
- Evaluating the Incidence of Organ Decompensations according Their Number, Percentage, and 95% Confidence Interval and Survival Analysis Methods: Kaplan Meier and Cox Model(6 months)
- Assessment of the incidence of serious and non-serious side effects using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model. Kaplan Meier and Cox model(3 months)
- Comparison of the incidence of symptomatic and severe coronavirus in vaccinated and unvaccinated subjects using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox Model. Kaplan Meier and Cox model(3 months)