Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

International Vaccine Institute (IVI)

Status: Enrolling

Conditions: Sars-CoV-2 Infection

Treatments: Other: Sinopharm Vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05362682

IVI-ECOVA-03

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

Case

Treatment:

Other: Sinopharm Vaccine

Test Negative Control

Treatment:

Other: Sinopharm Vaccine