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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

757

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2022

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

May 27, 2022

Completed

7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed

5 days until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed

Last Updated

November 7, 2023

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

May 27, 2022

Last Update Submit

November 3, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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 Outcomes (9)

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
+4 more secondary outcomes

Study Arms (7)

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.