Clinical trial NCT05403307: A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil
Official title: A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Paraná
name: Pfizer
name: Inova Medical
First posted: 2022-06-03
Enrollment: 757
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study population will be composed by individuals aged 5 to 11 years who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. Participants with a positive 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Odds of symptomatic SARS-CoV-2 infection
timeFrame: At the moment of enrollment
Secondary outcomes:
measure: Odds of symptomatic SARS-CoV-2 infection due to Omicron variant
timeFrame: At the moment of enrollment
measure: Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern
timeFrame: At the moment of enrollment
measure: Duration of COVID-19 symptoms
timeFrame: within 90 days from enrollment
measure: Incidence of hospitalization due to COVID-19
timeFrame: Within 90 days from enrollment
measure: Incidence of PICU admission
timeFrame: Within 90 days from enrollment
measure: Incidence of invasive mechanical ventilation
timeFrame: Within 90 days from enrollment
measure: Incidence of multisystem inflammatory syndrome
timeFrame: Within 90 days from enrollment
measure: Mortality due to COVID-19
timeFrame: Within 90 days from enrollment
measure: Prevalence of long COVID-19 symptoms at 3 months
timeFrame: Within 90 days from enrollment
Other outcomes:
Locations:
city: Toledo
country: Brazil
facility: Jardim Coopagro
state: PR
city: Toledo
country: Brazil
facility: Jardim Cosmos primary healthcare unit
state: PR
city: Toledo
country: Brazil
facility: Jardim Maracanã
state: PR
city: Toledo
country: Brazil
facility: Jardim Porto Alegre
state: PR
city: Toledo
country: Brazil
facility: Pediatric Emergency Service
state: PR
Study officials:
affiliation: Hospital Moinhos de Vento, INOVA
name: Regis G Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento, INOVA
name: Maicon Falavigna, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: