Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- P95
- Enrollment
- 59
- Locations
- 5
- Primary Endpoint
- SARS-CoV-2 detection
Study Overview
Brief Summary
This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules.
Detailed Description
This multi-country study seeks to collect RWE, from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes and when administered in different schedules.
The vaccines of interest are the following:
- 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),
- 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),
- 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
SARS-CoV-2 detection
Time Frame: Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)
The outcome of interest for the primary analysis will be the SARS-CoV-2 detection from study participants who present to the ER ("ER visit") or are hospitalized with SARI, as determined through the standard of care diagnostic testing (i.e., antigen test or PCR).
Secondary Outcomes
- Level of disease severity(- The Time Frame will be defined as the time from ER/Hospital admission to the date of hospital discharge or date of death at hospital)