A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil
- Conditions
- COVID-19
- Interventions
- Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineBiological: CoronaVac COVID-19 vaccine
- 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
- Arm && Interventions
Group Intervention Description One dose or more of BNT162b2 Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine Defined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset. Two doses of BNT162b2 Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine Defined as 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. Three doses of BNT162b2 Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine Defined as 3 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 3rd dose and acute respiratory illness (ARI) symptom onset. Two doses or more of BNT162b2 Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine Defined as ≥ 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective. One dose of BNT162b2 Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine Defined as 1 dose (only) of Pfizer/BioNTech BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset. Fully vaccinated with other available COVID-19 vaccines CoronaVac COVID-19 vaccine Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations.
- 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 invasive mechanical ventilation Within 90 days from enrollment Incidence of invasive mechanical ventilation
Incidence of multisystem inflammatory syndrome Within 90 days from enrollment Incidence of multisystem inflammatory syndrome
Mortality due to COVID-19 Within 90 days from enrollment Incidence of COVID-19-related mortality
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
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 Porto Alegre
🇧🇷Toledo, PR, Brazil
Jardim Cosmos primary healthcare unit
🇧🇷Toledo, PR, Brazil
Jardim Maracanã
🇧🇷Toledo, PR, Brazil
Pediatric Emergency Service
🇧🇷Toledo, PR, Brazil