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Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Non-commercial multicentre academic prospective cohort study in nursing home staff and residents during the winter season 2020-2021 and 2021-2022

Phase 1
Conditions
Healthy persons from age 18 till age 100
Therapeutic area: Body processes [G] - Immune system processes [G12]
Registration Number
EUCTR2021-000401-24-BE
Lead Sponsor
Sciensano
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
300
Inclusion Criteria

-Being enrolled and participating in the PICOV 2 study.
-Having previously received two doses of BNT162b2 COVID-19 mRNA vaccine (Comirnaty).

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

-Pregnancy.
-Having previously received one or more doses of a commercially available COVID-19 vaccine other than BNT162b2 (Comirnaty).
-Having participated in any other phase 1/2/3 clinical trial where a COVID-19 vaccine candidate has been administered.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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