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

I

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

  • 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.

Exclusion criteria

  • 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.

Trial design

3,000 participants in 2 patient groups

Case
Treatment:
Other: Sinopharm Vaccine
Test Negative Control
Treatment:
Other: Sinopharm Vaccine

Trial contacts and locations

1

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Central trial contact

Birkneh Tilahun Tadesse, PhD; Florian Marks, PhD

Data sourced from clinicaltrials.gov

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