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A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil

NCT05052307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4574

Last updated 2023-11-07

No results posted yet for this study

Summary

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences following a mass vaccination campaign in the city of Toledo in Southern Brazil.

Individuals aged 12 years or older who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 will be classified as cases, and those with negative PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of one year by means of structured telephone interviews.

Conditions

  • Covid19

Interventions

DRUG

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

DRUG

CoronaVac COVID-19 vaccine

CoronaVac COVID-19 vaccine

DRUG

ChAdOx1 nCoV-19 Covid-19 Vaccine

ChAdOx1 nCoV-19 Covid-19 Vaccine

DRUG

Ad26.COV2.S COVID-19 Vaccine

Ad26.COV2.S COVID-19 Vaccine

Sponsors & Collaborators

  • Universidade Federal do Paraná

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Inova Medical

    collaborator OTHER

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Regis G Rosa, MD, PhD · Hospital Moinhos de Vento

  • Maicon Falavigna, MD, PhD · Hospital Moinhos de Vento

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2022-06-20
Completion
2023-07-20
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052307 on ClinicalTrials.gov