Status:
COMPLETED
A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil
Lead Sponsor:
Hospital Moinhos de Vento
Collaborating Sponsors:
Universidade Federal do Paraná
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
5-11 years
Brief 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 ag...
Eligibility Criteria
Inclusion
- Age between 5 and 11 years;
- Resident of Toledo city;
- Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
- Nasal or nasopharyngeal sample for SARS-CoV-2 test obtained as standard of care.
Exclusion
- SARS-CoV-2-directed antiviral treatment within the past 30 days;
- COVID-19 monoclonal antibody therapy within the past 90 days;
- COVID-19 convalescent serum therapy within the past 90 days;
- Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.
Key Trial Info
Start Date :
June 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
757 Patients enrolled
Trial Details
Trial ID
NCT05403307
Start Date
June 8 2022
End Date
July 17 2023
Last Update
November 7 2023
Active Locations (5)
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1
Jardim Coopagro
Toledo, Paraná, Brazil
2
Jardim Cosmos primary healthcare unit
Toledo, Paraná, Brazil
3
Jardim Maracanã
Toledo, Paraná, Brazil
4
Jardim Porto Alegre
Toledo, Paraná, Brazil