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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.
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:
Serology data prescribed by doctors as part of routine care will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccinated group | |||
| unvaccinated group |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months or 18 months in the case of the 3rd vaccinal injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Carrying out adjustment analyzes by multivariate logistic regressions on confounding factors | 3 months | |
| Performing propensity score analyzes to balance the vaccinated and unvaccinated groups | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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Retirement Home (EHPAD) residents and Long-term Care Units (USLD) patients vaccinated or not against Coronavivus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Dufour | Contact | +33 (0)185781010 | isabelle.dufour@gerondif.org | |
| Adrien Besseiche | Contact | +33 (0)185781010 | adrien.besseiche@gerondif.org |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Hanon, MD PhD | Geriatric Department, Broca hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Department, Broca Hospital | Recruiting | Paris | IIe-de-France | 75013 | France |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| 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 |
| D007239 |
| Infections |