Sars-CoV-2 Infection
Conditions
Brief summary
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.
Interventions
OTHERSinopharm Vaccine
Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign
Sponsors
The Coalition for Epidemic Preparedness Innovations (CEPI)
Instituto Nacional de Saúde, Mozambique
University of Antananarivo
International Centre for Diarrhoeal Disease Research, Bangladesh
Harvard University
Heidelberg University
International Vaccine Institute
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and 2. They are at least 18 years of age during first round of mass vaccination. 3. Their onset of symptoms was \<10 days prior to testing. 4. 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.
Exclusion criteria
1. We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days 2. Any Participant not matching the inclusion criteria mentioned above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection | 2 years | Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against RT-PCR confirmed severe SARS-CoV-2 infection |
Countries
Mozambique
Contacts
Primary ContactFlorian Marks, PhD
Backup ContactBirkneh Tilahun Tadesse, PhD
Outcome results
None listed