NCT05052307

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

Effectiveness of Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine on Symptomatic SARS-CoV-2 Infection and COVID-19-related Hospitalizations, Mortality, and Long-term Consequences in Brazil: a Real-world Evidence Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,574 (actual)
• Sponsor: Hospital Moinhos de Vento · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: —

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-06-20
• Completion: 2023-07-20
• First posted: 2021-09-22
• Last updated: 2023-11-07

Locations

3 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study