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

COVID-19 Clinical Trial

Official title:

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403307
• Other study ID #: BNT162b2 pediatric Toledo
• Status: Completed
• Start date: June 8, 2022
• Est. completion date: July 17, 2023

Study information

• Verified date: May 2022
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: July 17, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Brazil	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

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Inova Medical, Pfizer, Universidade Federal do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds of symptomatic SARS-CoV-2 infection	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).	At the moment of enrollment
Secondary	Odds of symptomatic SARS-CoV-2 infection due to Omicron variant	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	At the moment of enrollment
Secondary	Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern	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.	At the moment of enrollment
Secondary	Duration of COVID-19 symptoms	Length of COVID-19-related symptoms	within 90 days from enrollment
Secondary	Incidence of hospitalization due to COVID-19	Incidence of hospital admission due to COVID-19	Within 90 days from enrollment
Secondary	Incidence of PICU admission	Incidence of Pediatric intensive care unit admission	Within 90 days from enrollment
Secondary	Incidence of invasive mechanical ventilation	Incidence of invasive mechanical ventilation	Within 90 days from enrollment
Secondary	Incidence of multisystem inflammatory syndrome	Incidence of multisystem inflammatory syndrome	Within 90 days from enrollment
Secondary	Mortality due to COVID-19	Incidence of COVID-19-related mortality	Within 90 days from enrollment
Secondary	Prevalence of long COVID-19 symptoms at 3 months	Prevalence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache)	Within 90 days from enrollment