Skip to main content
OpenTrials
Completed

NCT Number: NCT05403307

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jardim Coopagro, Toledo, Paraná, Brazil

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

Biological

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine

CoronaVac COVID-19 vaccine

Biological

CoronaVac COVID-19 vaccine

Primary outcomes

  1. Odds of symptomatic SARS-CoV-2 infection

    Time frame: 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 outcomes

  1. Odds of symptomatic SARS-CoV-2 infection due to Omicron variant

    Time frame: 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

  2. Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern

    Time frame: 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.

  3. Duration of COVID-19 symptoms

    Time frame: within 90 days from enrollment

    Length of COVID-19-related symptoms

  4. Incidence of hospitalization due to COVID-19

    Time frame: Within 90 days from enrollment

    Incidence of hospital admission due to COVID-19

  5. Incidence of PICU admission

    Time frame: Within 90 days from enrollment

    Incidence of Pediatric intensive care unit admission

  6. Incidence of invasive mechanical ventilation

    Time frame: Within 90 days from enrollment

    Incidence of invasive mechanical ventilation

  7. Incidence of multisystem inflammatory syndrome

    Time frame: Within 90 days from enrollment

    Incidence of multisystem inflammatory syndrome

  8. Mortality due to COVID-19

    Time frame: Within 90 days from enrollment

    Incidence of COVID-19-related mortality

  9. Prevalence of long COVID-19 symptoms at 3 months

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Inova Medical
  • Pfizer
  • Universidade Federal do Paraná

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.