An observational study in Reside Either in Retirement Home or Long-term Care Units, sponsored by Gérond'if. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Gérond'if · Observational
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 3,309 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Gérond'if is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Retirement Home (EHPAD) residents and Long-term Care Units (USLD) patients vaccinated or not against Coronavivus.
Exclusion Criteria:
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
Time frame: 12 months or 18 months in the case of the 3rd vaccinal injection
Assessment of the incidence of geriatric syndromes using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Carrying out adjustment analyzes by multivariate logistic regressions on confounding factors
Time frame: 3 months
Performing propensity score analyzes to balance the vaccinated and unvaccinated groups
Time frame: 3 months
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Gérond'if