MedTrace Logo

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

NCT05403307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 757

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 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

Interventions

BIOLOGICAL

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

BIOLOGICAL

CoronaVac COVID-19 vaccine

CoronaVac 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, INOVA

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

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2023-04-30
Completion
2023-07-17
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
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 NCT05403307 on ClinicalTrials.gov