Health TrialsbyHealthPanel

COVID-19 Vaccines Safety Tracking (CoVaST)

ConditionsAdverse Reaction to VaccineCOVID19 Vaccine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non HCW, OA and ST who received the COVID-19.

Trial population

In Phase A, a pragmatic approach will track each target group according to the governmental plan; in most countries, it went from HCW to OA to ST. The sample of Phase B will be pre-identified based on the outcome of Phase A. If ≥ 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest to join Phase B, no additional recruitment will be required. If \< 25% of HCW, 10% of OA and 10% of ST of Phase A showed their interest in Phase B, additional recruitment will be carried out targeting healthcare workers who will receive booster doses. In case of the emergence of special side effects after booster doses, additional recruitment of healthcare workers will be required.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • BNT162b2

    Biological/Vaccine

    Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)

  • mRNA-1273

    Biological/Vaccine

    Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)

  • AZD1222

    Biological/Vaccine

    Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)

  • CoronaVac

    Biological/Vaccine

    Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)

  • Sinopharm

    Biological/Vaccine

    Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine

  • Gam-COVID-Vac

    Biological/Vaccine

    Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)

  • JNJ-78436735

    Biological/Vaccine

    Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)

  • CVnCoV

    Biological/Vaccine

    Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)

  • NVX-CoV2373

    Biological/Vaccine

    Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)

  • BBV152

    Biological/Vaccine

    Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)

Treatment groups

30,000 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Pfizer-BioNTech COVID-19 Vaccine1 intervention
Group B: Moderna COVID-19 Vaccine1 intervention
Group C: AstraZeneca-Oxford University COVID-19 Vaccine1 intervention
Group D: CoronaVac1 intervention
Group E: Sinopharm1 intervention
Group F: Sputnik V1 intervention
Group G: Janssen1 intervention
Group H: CureVac1 intervention
Group I: Novavax1 intervention
Group J: Covaxin1 intervention
Group K: CanSino0 interventions

Trial outcomes

Primary outcomes

1

Local Side Effects

Dichotomous outcome for the emergence of local side effects (e.g. injection site pain, injection site swelling, and injection site redness)

Time frame
0-30 days after the COVID-19 vaccine shot
2

Systemic Side Effects

Dichotomous outcome for the emergence of systemic side effects (e.g. fever, chills, headache, fatigue, nausea, diarrhea, etc)

Time frame
0-30 days after the COVID-19 vaccine shot

Secondary outcomes

1

Unrecognized Side Effects

Dichotomous outcome for the emergence of oral and dermatologic side effects (e.g. oral paresthesia, oral ulcers, dysgeusia, skin rash, acne, urticaria, etc)

Time frame
0-30 days after the COVID-19 vaccine shot

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masaryk University

Lead sponsor

Source ClinicalTrials.gov
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