NCT04900376

Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,100 (estimated)
• Sponsor: Gérond'if · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 Serology data prescribed by doctors as part of routine care will also be collected.

Conditions

• Reside Either in Retirement Home or Long-term Care Units

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-12-31
• Completion: 2023-07-01
• First posted: 2021-05-25
• Last updated: 2023-03-06

Locations

1 site across 1 country: France