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

Objective :

Vaccine

Patients Population :

Healthy volunteers; oncological patients; health care workers

Intervention :

Blood draw

Comparison :

Phase IV study: Antibody levels and cellular immunity parameters will be compared in relation to initial values; subgroup of oncological patients will be compared to non-oncological patients

Outcome :

Vaccine safety and effectiveness

Location :

Czech Republic

Rationale :

Multicentric prospective open Phase IV clinical study to assess effectiveness of vaccines and monitor their safety. The study will examine the incidence of COVID-19 in vaccinated subjects based on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease). It will also monitor adverse events and effects through collecting information on the severity, duration and nature of adverse events. Furthermore, it will evaluate the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time. Also, within a subgroup of oncological patients, this study will monitor adverse events, assess the incidence among vaccinated subjects and assess the immune profile and analyze the parameters in light of the type of cancer treatment administered.

Document :