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

NCT ID: NCT05362682

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-24

Study Completion Date

2024-08-30

Brief Summary

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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

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Conditions

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Sars-CoV-2 Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Sinopharm Vaccine

Intervention Type OTHER

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

Test Negative Control

Sinopharm Vaccine

Intervention Type OTHER

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

Interventions

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Sinopharm Vaccine

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Coalition for Epidemic Preparedness Innovations (CEPI)

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

Sponsor Role collaborator

University of Antananarivo

UNKNOWN

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

International Vaccine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dondo Health Facility

Dondo, , Mozambique

Site Status RECRUITING

Countries

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Mozambique

Central Contacts

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Florian Marks, PhD

Role: CONTACT

+821087033813

Birkneh Tilahun Tadesse, PhD

Role: CONTACT

+821098041348

Facility Contacts

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Ilesh Jani, PhD

Role: primary

+258825802221

Other Identifiers

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IVI-ECOVA-03

Identifier Type: -

Identifier Source: org_study_id

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