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

Recruiting

• Conditions: Sars-CoV-2 Infection
• Interventions: Other: Sinopharm Vaccine

• Registration Number: NCT05362682
• Lead Sponsor: International Vaccine Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-24
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-02-28
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Sinopharm Vaccine	-
Test Negative Control	Sinopharm Vaccine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dondo Health Facility; 🇲🇿 Dondo, Mozambique