SARS-Cov-2 vaccine responsiveness in middle-aged and older persons

Phase 1

• Conditions: SARS-CoV-19, frailty; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-001976-40-NL
• Lead Sponsor: ational Institute for Public Health and the Environment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

•Having participated in round 6 of the Doetinchem Cohort study or living in a nursing home
•Willing to receive the SARS-CoV-2 vaccine or received the vaccinations not longer than 1 month in advance for the DC participants or no longer than 7 months ago for nursing home residents.
•Willing to sign the Informed Consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 325
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1375

Exclusion Criteria

•Participant of the DC already received their second SARS-CoV-2 vaccination more than 1 month before signing the ICF, so sampling at T2 and further is not possible.
•Participants living in a nursing home already received both primary SARS-CoV-2 vaccinations more than 7 months before signing ICF.
•Incapacitated participants

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified