Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean

P95

Status: Completed

Conditions: COVID-19

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05475704

PRJ000284

Details and patient eligibility

About

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.

Full 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).

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients need to fulfill all the following criteria to be eligible for the study:

• Being 18 years old or older
• Ever eligible for vaccination2 with any of the Chinese COVID-19 vaccines provided in their country as per national/regional immunization recommendations prior to hospital admission
• ER consultation or hospitalization due to SARI
• Willing and able to provide informed consent (or by a legally accepted representative if the patient is not able to provide a signature by him/herself)

Exclusion Criteria

Patients that fulfill one or more of the following criteria will not be eligible for the study:

• Patients vaccinated against COVID-19 but not with the vaccines of interest
• Patients admitted or hospitalized for other condition than SARI
• Patients to whom it is not possible to perform a diagnostic test (antigen or PCR) for SARS-CoV-2

Trial design

59 participants in 2 patient groups

Case group

Description:

Test-positive cases are study participants that meet the SARI case definition AND test positive for at least one SARS-CoV-2 diagnostic test, with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter

Control group

Description:

Test-negative controls are study participants that meet the SARI case definition AND test negative for all SARS-CoV-2 diagnostic test with specimens collected up to 14 days prior to ER visit or hospitalization or up to 24 hours thereafter