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

Hospital Moinhos de Vento

Status: Completed

Conditions: COVID-19

Treatments: Biological: CoronaVac COVID-19 vaccine; Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05403307

BNT162b2 pediatric Toledo

Details and patient eligibility

About

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.

Enrollment: 757 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

757 participants in 7 patient groups

Two doses or more of BNT162b2

Description:

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.

Treatment:

Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

One dose of BNT162b2

Description:

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.

Treatment:

Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

One dose or more of BNT162b2

Description:

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.

Treatment:

Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Two doses of BNT162b2

Description:

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.

Treatment:

Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Three doses of BNT162b2

Description:

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.

Treatment:

Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Fully vaccinated with other available COVID-19 vaccines

Description:

Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations.

Treatment:

Biological: CoronaVac COVID-19 vaccine

Never vaccinated

Description:

Defined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses.