A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 5
- 主要终点
- Odds of symptomatic SARS-CoV-2 infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Odds of symptomatic SARS-CoV-2 infection
时间窗: 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).
次要结局
- Incidence of multisystem inflammatory syndrome(Within 90 days from enrollment)
- Odds of symptomatic SARS-CoV-2 infection due to Omicron variant(At the moment of enrollment)
- Incidence of invasive mechanical ventilation(Within 90 days from enrollment)
- Mortality due to COVID-19(Within 90 days from enrollment)
- Prevalence of long COVID-19 symptoms at 3 months(Within 90 days from enrollment)
- Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern(At the moment of enrollment)
- Incidence of hospitalization due to COVID-19(Within 90 days from enrollment)
- Incidence of PICU admission(Within 90 days from enrollment)
- Duration of COVID-19 symptoms(within 90 days from enrollment)