NCT05362682招募中不适用
Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease
研究概览
简要总结
Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
- •They are at least 18 years of age during first round of mass vaccination.
- •Their onset of symptoms was <10 days prior to testing.
- •For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.
排除标准
- •We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
- •Any Participant not matching the inclusion criteria mentioned above.
结局指标
主要结局
Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease
时间窗: 2 years
Protection conferred by two completed doses of Sinopharm vaccine against RT-PCR-confirmed COVID-19 disease measured as the reduction in risk in adults who received two completed doses of the vaccine compared to those who are not vaccinated.
次要结局
- Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection(2 years)
研究者
研究点 (1)
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