A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Two doses or more of BNT162b2 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. |
Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| One dose of BNT162b2 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. |
Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| One dose or more of BNT162b2 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. |
Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| Two doses of BNT162b2 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. |
Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| Three doses of BNT162b2 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. |
Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
|
| Fully vaccinated with other available COVID-19 vaccines Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations. |
Biological: CoronaVac COVID-19 vaccine
CoronaVac COVID-19 vaccine
|
| Never vaccinated 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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.
- Duration of COVID-19 symptoms [within 90 days from enrollment]
Length of COVID-19-related symptoms
- 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
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 5 and 11 years;
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Resident of Toledo city;
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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).
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Nasal or nasopharyngeal sample for SARS-CoV-2 test obtained as standard of care.
Exclusion Criteria:
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SARS-CoV-2-directed antiviral treatment within the past 30 days;
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COVID-19 monoclonal antibody therapy within the past 90 days;
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COVID-19 convalescent serum therapy within the past 90 days;
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Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unidade de Pronto Atendimento (UPA) de Toledo | Toledo | Paraná | Brazil |
Sponsors and Collaborators
- Hospital Moinhos de Vento
- Universidade Federal do Paraná
- Pfizer
- Inova Medical
Investigators
- Principal Investigator: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento, INOVA
- Principal Investigator: Maicon Falavigna, MD, PhD, Hospital Moinhos de Vento, INOVA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BNT162b2 pediatric Toledo