Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
30000 participants
OBSERVATIONAL
2021-04-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
NCT04844632
Immunization of 7 Different Vaccines Against SARS-COV-2 Across 4 Countries.
NCT05228912
Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study)
NCT05057169
Adverse Events Report of Inactivated COVID-19 Vaccine
NCT05026879
Safety and Immunogenicity Study of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers
NCT04666012
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore, mass vaccination has become a high priority for the world's governments. While vaccination strategies need to be accelerated to minimise daily fatalities and relieve the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for these efforts. VH refers to "delay in acceptance or refusal of vaccines despite availability of vaccine services",; and it is an emerging public health challenge nourished by misinformation related to vaccines effectiveness and safety. Aversion to vaccines' potential side effects is the most frequent cause of VH among population groups. Therefore, a recent systematic review revealed that raising public awareness of vaccines' effectiveness and side effects is vital for improving vaccine uptake.
Public health systems globally experience a novel and unique challenge due to the variety of vaccines manufacturers and the high levels of public awareness about those manufacturers and their marketing strategies. This unprecedented situation is predicted to create what we can refer to as "vaccine selectivity, " increasing the pressure on our weakened health systems and economies and increasing vaccine hesitancy levels. Independent (non-sponsored) studies with rigorous methods can perfectly lead the pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature and transparent design, these studies can play a key role in suppressing vaccine hesitancy levels by enhancing public confidence in vaccines.
Design
This project comprises two phases; a) a cross-sectional survey for the short-term side effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of COVID-19 vaccines.
Phase A:
A validated self-administered questionnaire will be developed and delivered online to the target population groups (HCW, OA \& ST). The questionnaire will be inquiring about the short-term side effects that emerged within 30 days following the vaccine shot (either the first or the second dose). The side effects will be classified as local or systemic, and their onset, duration, and intensity will be self-assessed and self-reported by the respondents. This phase is proposed to take place until December 31st, 2021.
Phase B:
A validated self-administered questionnaire will be developed and delivered online to the volunteers who participated in Phase A and expressed their interest to report their long-term side effects. In this phase, the vaccine effectiveness and side effects will be evaluated after booster doses. Phase B will take place for five consecutive years starting from 2022.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pfizer-BioNTech COVID-19 Vaccine
Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
BNT162b2
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
Moderna COVID-19 Vaccine
Recently vaccinated individuals by Moderna COVID-19 Vaccine
mRNA-1273
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
AstraZeneca-Oxford University COVID-19 Vaccine
Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
AZD1222
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
CoronaVac
Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
CoronaVac
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
Sinopharm
Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
Sinopharm
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
Sputnik V
Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
Gam-COVID-Vac
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
Janssen
Recently vaccinated individuals by Janssen COVID-19 Vaccine
JNJ-78436735
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
CureVac
Recently vaccinated individuals by CureVac COVID-19 Vaccine
CVnCoV
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
Novavax
Recently vaccinated individuals by Novavax COVID-19 Vaccine
NVX-CoV2373
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
Covaxin
Recently vaccinated individuals by Covaxin COVID-19 Vaccine
BBV152
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
CanSino
Recently vaccinated individuals by CanSino COVID-19 Vaccine
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BNT162b2
Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
mRNA-1273
Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
AZD1222
Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
CoronaVac
Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
Sinopharm
Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
Gam-COVID-Vac
Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
JNJ-78436735
Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
CVnCoV
Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
NVX-CoV2373
Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
BBV152
Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participating subjects should be at least 18-year-old and able to give their informed consent independently.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Masaryk University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American College of Physicians
Philadelphia, Pennsylvania, United States
McMaster University
Hamilton, Ontario, Canada
University of Split
Split, , Croatia
Masaryk University
Brno, , Czechia
University of Tartu
Tartu, , Estonia
Jimma University
Jimma, , Ethiopia
Justus-Liebig University Giessen
Giessen, , Germany
University of Ghana
Accra, , Ghana
Sinaloa's Pediatric Hospital
Culiacán, , Mexico
Medical University of Silesia
Katowice, , Poland
Nursing School of Coimbra
Coimbra, , Portugal
Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences
Irkutsk, , Russia
University of Belgrade
Belgrade, , Serbia
University of Ljubljana
Ljubljana, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Riad A, Pokorna A, Attia S, Klugarova J, Koscik M, Klugar M. Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic. J Clin Med. 2021 Apr 1;10(7):1428. doi: 10.3390/jcm10071428.
Riad A, Schunemann H, Attia S, Pericic TP, Zuljevic MF, Jurisson M, Kalda R, Lang K, Morankar S, Yesuf EA, Mekhemar M, Danso-Appiah A, Sofi-Mahmudi A, Perez-Gaxiola G, Dziedzic A, Apostolo J, Cardoso D, Marc J, Moreno-Casbas M, Wiysonge CS, Qaseem A, Gryschek A, Tadic I, Hussain S, Khan MA, Klugarova J, Pokorna A, Koscik M, Klugar M. COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects. Int J Environ Res Public Health. 2021 Jul 25;18(15):7859. doi: 10.3390/ijerph18157859.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CoVaST
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.