COVID-19 Vaccines Safety Tracking (CoVaST)

Conditions

• Adverse Reaction to Vaccine
• COVID19 Vaccine

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BNT162b2 — BIOLOGICAL
  Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
• mRNA-1273 — BIOLOGICAL
  Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
• AZD1222 — BIOLOGICAL
  Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
• CoronaVac — BIOLOGICAL
  Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
• Sinopharm — BIOLOGICAL
  Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
• Gam-COVID-Vac — BIOLOGICAL
  Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
• JNJ-78436735 — BIOLOGICAL
  Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
• CVnCoV — BIOLOGICAL
  Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
• NVX-CoV2373 — BIOLOGICAL
  Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
• BBV152 — BIOLOGICAL
  Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)

Study Details

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.

Key Dates

Start date

Apr 1, 2021

Status verified

Oct 2021

Primary completion

Dec 31, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

30,000 participants (estimated)

Arms

• Arm: Pfizer-BioNTech COVID-19 Vaccine
  Recently vaccinated individuals by Pfizer-BioNTech COVID-19 Vaccine (Comirnaty)
• Arm: Moderna COVID-19 Vaccine
  Recently vaccinated individuals by Moderna COVID-19 Vaccine
• Arm: AstraZeneca-Oxford University COVID-19 Vaccine
  Recently vaccinated individuals by AstraZeneca-Oxford University COVID-19 Vaccine (Vaxzevria)
• Arm: CoronaVac
  Recently vaccinated individuals by CoronaVac (Sinovac COVID-19 Vaccine)
• Arm: Sinopharm
  Recently vaccinated individuals by Vero Cells (Sinopharm COVID-19 Vaccine)
• Arm: Sputnik V
  Recently vaccinated individuals by Sputnik V COVID-19 Vaccine
• Arm: Janssen
  Recently vaccinated individuals by Janssen COVID-19 Vaccine
• Arm: CureVac
  Recently vaccinated individuals by CureVac COVID-19 Vaccine
• Arm: Novavax
  Recently vaccinated individuals by Novavax COVID-19 Vaccine
• Arm: Covaxin
  Recently vaccinated individuals by Covaxin COVID-19 Vaccine
• Arm: CanSino
  Recently vaccinated individuals by CanSino COVID-19 Vaccine

Primary Outcome Measure

Local Side Effects [ Time Frame: 0-30 days after the COVID-19 vaccine shot ]

Central Contacts

• Miloslav Klugar, PhD
  +420549495676
  [email protected]
• Abanoub Riad, DDS
  +420549496572
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA