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| Name | Class |
|---|---|
| Universidade Federal do Paraná | OTHER |
| Pfizer | INDUSTRY |
| Inova Medical | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine | Biological | Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Regis G Rosa, MD, PhD | Hospital Moinhos de Vento, INOVA | Principal Investigator |
| Maicon Falavigna, MD, PhD | Hospital Moinhos de Vento, INOVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jardim Coopagro | Toledo | Paraná | Brazil | |||
| Jardim Cosmos primary healthcare unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39069096 | Derived | Rodrigues CO, Spinardi J, Rosa RG, Falavigna M, de Souza EM, Manfio JL, de Souza AP, de Araujo CLP, Cohen M, Barbosa GRGDV, Silva FKR, Sganzerla D, da Silva MMD, Ferreira D, Kunkel NT, Camargo NI, Sarturi JC, Guilhem MC, de Oliveira JC, Lopes CC, Widmar F, Barufi LK, da Silva GN, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Baura VA, Abreu H, Poitevin CG, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Castillo GDCM, McLaughlin JM; Toledo BNT162b2 Study Group Investigators. Real-world effectiveness of original BNT162b2 mRNA COVID-19 against symptomatic Omicron infection among children 5-11 years of age in Brazil: A prospective test-negative design study. Immunol Lett. 2024 Oct;269:106903. doi: 10.1016/j.imlet.2024.106903. Epub 2024 Jul 26. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
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| Fully vaccinated with other available COVID-19 vaccines | Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations. |
|
| 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. |
| CoronaVac COVID-19 vaccine | Biological | CoronaVac COVID-19 vaccine |
|
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 |
| Duration of COVID-19 symptoms | Length of COVID-19-related symptoms | within 90 days from enrollment |
| Incidence of hospitalization due to COVID-19 | Incidence of hospital admission due to COVID-19 | Within 90 days from enrollment |
| Incidence of PICU admission | Incidence of Pediatric intensive care unit admission | Within 90 days from enrollment |
| Incidence of invasive mechanical ventilation | Incidence of invasive mechanical ventilation | Within 90 days from enrollment |
| Incidence of multisystem inflammatory syndrome | Incidence of multisystem inflammatory syndrome | Within 90 days from enrollment |
| Mortality due to COVID-19 | Incidence of COVID-19-related mortality | Within 90 days from enrollment |
| 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 |
| Toledo |
| Paraná |
| Brazil |
| Jardim Maracanã | Toledo | Paraná | Brazil |
| Jardim Porto Alegre | Toledo | Paraná | Brazil |
| Pediatric Emergency Service | Toledo | Paraná | Brazil |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |