NCT04834869 · Masaryk University
COVID-19 Vaccines Safety Tracking (CoVaST)
What this study is about
This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.
View original scientific description
This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.
Interventions
BIOLOGICAL
BNT162b2
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
BIOLOGICAL
mRNA-1273
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
BIOLOGICAL
AZD1222
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
BIOLOGICAL
CoronaVac
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
BIOLOGICAL
Sinopharm
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
BIOLOGICAL
Gam-COVID-Vac
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
BIOLOGICAL
JNJ-78436735
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
BIOLOGICAL
CVnCoV
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
BIOLOGICAL
NVX-CoV2373
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
BIOLOGICAL
BBV152
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
Primary outcome measures
Local Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)
Systemic Side Effects
Time frame: 0-30 days after the COVID-19 vaccine shot
Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- HCW, OA and ST who received COVID-19 vaccine.
- Participating subjects should be at least 18-year-old and able to give their informed consent independently.
Exclusion criteria
- Non HCW, OA and ST who received the COVID-19.
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2022 · Source of record for eligibility and locations