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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2023-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic

NCT04974164

COVID-19

COMPLETED

LatInamerican Vaccine Effectiveness Against Hospitalizations Due to Circulating COVID-19 VoC RWE Study

NCT05282017

COVID-19, SARS-CoV-2

COMPLETED

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

NCT05112913

COVID-19

ACTIVE_NOT_RECRUITING PHASE4

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

NCT04816643

SARS-CoV-2 Infection, COVID-19

COMPLETED PHASE2/PHASE3

Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years

NCT05137418

COVID-19

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

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

No interventions assigned to this group

Control group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No