A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil
- Conditions
- COVID-19
- Registration Number
- NCT05403307
- Lead Sponsor
- Hospital Moinhos de Vento
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 757
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Odds of symptomatic SARS-CoV-2 infection At the moment of enrollment Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness 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).
- Secondary Outcome Measures
Name Time Method Incidence of multisystem inflammatory syndrome Within 90 days from enrollment Incidence of multisystem inflammatory syndrome
Odds of symptomatic SARS-CoV-2 infection due to Omicron variant At the moment of enrollment Odds of symptomatic SARS-CoV-2 infection due to Omicron variant defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 Omicron variant
Incidence of invasive mechanical ventilation Within 90 days from enrollment Incidence of invasive mechanical ventilation
Mortality due to COVID-19 Within 90 days from enrollment Incidence of COVID-19-related mortality
Prevalence of long COVID-19 symptoms at 3 months Within 90 days from enrollment Prevalence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache)
Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern At the moment of enrollment Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 variants of concern.
Incidence of hospitalization due to COVID-19 Within 90 days from enrollment Incidence of hospital admission due to COVID-19
Incidence of PICU admission Within 90 days from enrollment Incidence of Pediatric intensive care unit admission
Duration of COVID-19 symptoms within 90 days from enrollment Length of COVID-19-related symptoms
Trial Locations
- Locations (5)
Jardim Coopagro
🇧🇷Toledo, PR, Brazil
Jardim Cosmos primary healthcare unit
🇧🇷Toledo, PR, Brazil
Jardim Maracanã
🇧🇷Toledo, PR, Brazil
Jardim Porto Alegre
🇧🇷Toledo, PR, Brazil
Pediatric Emergency Service
🇧🇷Toledo, PR, Brazil
Jardim Coopagro🇧🇷Toledo, PR, Brazil