Post-authorization Phase IV effectiveness and safety multicentric study of COVID-19 vaccines – CoVigi

Phase 1

Active, not recruiting

• Conditions: COVID-19 Vaccines, monitoring of adverse events and evaluation of the immune response; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000566-14-CZ
• Lead Sponsor: Masarykova univerzita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-17
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 565

Inclusion Criteria

1) Age = 18 years
2) Willingness to participate in the study expressed by signing the informed consent form

A subject can be included in a cohort of newly enrolled subjects with an already fully applied vaccination scheme according to SmPC, if they additionally meet the following criteria:
1) Patient in the care of the Department of Internal Hematology and Oncology, University Hospital Brno
2) Planned booster dose (3rd dose for the originally two-dose schedule, or 2nd dose for the single-dose schedule)
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 282
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 283

Exclusion Criteria

1) Pregnancy, breastfeeding
2) Inadequacy of patient classification based on the individual assessment of the study physician

Study & Design

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