NCT05403307|CompletedFDA Drug
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Sponsor study identifier
observational
757
1 country
5
Study Start
June 8, 2022
Actual (reported)Primary Completion
April 30, 2023
Actual (reported)Study Completion
July 17, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 17, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2022
Actual (reported)June 3, 2022
Actual (reported)June 8, 2022
Actual (reported)April 30, 2023
Actual (reported)July 17, 2023
Actual (reported)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
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 other circulating variants of concern
At the moment of enrollment
Duration of COVID-19 symptoms
within 90 days from enrollment
Incidence of hospitalization due to COVID-19
Within 90 days from enrollment
Incidence of PICU admission
Within 90 days from enrollment
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.
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.
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.
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.
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
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.
Jardim Coopagro
Toledo, Paraná, Brazil
Jardim Cosmos primary healthcare unit
Toledo, Paraná, Brazil
Jardim Maracanã
Toledo, Paraná, Brazil
Jardim Porto Alegre
Toledo, Paraná, Brazil
Pediatric Emergency Service
Toledo, Paraná, Brazil
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.
Regis G Rosa, MD, PhD
Hospital Moinhos de Vento, INOVA
Maicon Falavigna, MD, PhD
Hospital Moinhos de Vento, INOVA
757 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2022
First Posted
June 3, 2022
Study Start
June 8, 2022
Actual (reported)Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected)
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.
Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 30, 2023
Actual (reported)Study Completion
July 17, 2023
Actual (reported)Last Updated
November 7, 2023
Record last verified: 2022-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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