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

Sars-CoV-2 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362682
• Other study ID #: IVI-ECOVA-03
• Status: Recruiting
• Start date: February 24, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2023
• Source: International Vaccine Institute
• Contact: Florian Marks, PhD
• Phone: +821087033813
• Email: fmarks[@]ivi.int
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

Other:
• Sinopharm Vaccine
Sinopharm Vaccine will be administered by the Govt as part of COVID-19vaccination campaign

Locations

Country	Name	City	State
Mozambique	Dondo Health Facility	Dondo

Sponsors (7)

Lead Sponsor	Collaborator
International Vaccine Institute	Harvard University, Heidelberg University, Instituto Nacional de Saúde (INS), Mozambique, International Centre for Diarrhoeal Disease Research, Bangladesh, The Coalition for Epidemic Preparedness Innovations (CEPI), University of Antananarivo

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protection conferred by two completed doses of Sinopharm vaccine against confirmed COVID-19 disease	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.	2 years
Secondary	Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against severe SARS-CoV-2 infection	Evaluate the effectiveness of two completed doses of the Sinopharm vaccine against RT-PCR confirmed severe SARS-CoV-2 infection	2 years