NCT05403307

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

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 757 (actual)
• Sponsor: Hospital Moinhos de Vento · Academic / Other
• Sex: All
• Age: 5 Years – 11 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 among children aged 5 to 11 years in the city of Toledo in Southern Brazil. Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine	Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
BIOLOGICAL	CoronaVac COVID-19 vaccine	CoronaVac COVID-19 vaccine

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-04-30
• Completion: 2023-07-17
• First posted: 2022-06-03
• Last updated: 2023-11-07

Locations

5 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study