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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000566-14-CZ

Enrollment

565

Registered

2021-02-17

Start date

2021-03-17

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccines, monitoring of adverse events and evaluation of the immune response MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865

Interventions

Trade Name: VAXZEVRIA Pharmaceutical Form: Suspension for injection Trade Name: SPIKEVAX Pharmaceutical Form: Dispersion for injection Trade Name: COMIRNATY Pharmaceutical Form: Dispersion for injec

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) Post-authorization monitoring of adverse events and effects (data collection based on a questionnaire survey and evaluation by study physician) • Severity, expectations, intensity, relationship to vaccination • Nature of adverse event, duration 2) Evaluation of the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time 3) Incidence of COVID-19 disease in vaccinated subjects based on information on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease);Secondary Objective: Exploratory: In a subgroup of cancer patients (patients with solid tumors) undergoing active anticancer therapy: • Monitoring and evaluation of objectives and parametrs mentioned as primary • Evaluation of the circulating immune profile • Evaluation of objectives and parameters in connection with the type of cancer treatment administered ;Primary end point(s): 1) monitoring for adverse events and effects 2) evaluation of the immune response of vaccinated subjects 3) incidence of COVID-19 disease in vaccinated subjects;Timepoint(s) of evaluation of this end point: 1) visit 2, 3 and 4 2) baseline (visit 1), visit 2, 3, 4, 5 and 6 3) from first vaccination dose to end of trial	—

Measure

Time frame

Main Objective: 1) Post-authorization monitoring of adverse events and effects (data collection based on a questionnaire survey and evaluation by study physician) • Severity, expectations, intensity, relationship to vaccination • Nature of adverse event, duration 2) Evaluation of the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time 3) Incidence of COVID-19 disease in vaccinated subjects based on information on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease);Secondary Objective: Exploratory: In a subgroup of cancer patients (patients with solid tumors) undergoing active anticancer therapy: • Monitoring and evaluation of objectives and parametrs mentioned as primary • Evaluation of the circulating immune profile • Evaluation of objectives and parameters in connection with the type of cancer treatment administered ;Primary end point(s): 1) monitoring for adverse events and effects 2) evaluation of the immune response of vaccinated subjects 3) incidence of COVID-19 disease in vaccinated subjects;Timepoint(s) of evaluation of this end point: 1) visit 2, 3 and 4 2) baseline (visit 1), visit 2, 3, 4, 5 and 6 3) from first vaccination dose to end of trial

—

Secondary

Measure	Time frame
Secondary end point(s): Monitoring and evaluation of primary objectives and parameters in a subgroup of cancer patients and evaluation of the circulating immune profile;Timepoint(s) of evaluation of this end point: End of trial	—

Countries

Czech Republic

Contacts

Public ContactFarmakologický ústav LF MU

Masarykova univerzita

demlova@med.muni.cz

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 9, 2026