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Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity

NCT04789356 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6233

Last updated 2021-07-26

No results posted yet for this study

Summary

This is a quasi-experimental study with risk-based allocation. Public security and education professionals from the state government will be included. In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19. Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days). Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project. If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after). All participants will be followed up for 12 months from inclusion in the study. Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Adsorbed SARS-CoV-2 (inactivated) vaccine

600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Sponsors & Collaborators

  • Butantan Institute

    collaborator OTHER_GOV

  • Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

    lead OTHER

Principal Investigators

  • Marcus Lacerda, MD · Fundação de Medicina Tropical Heitor Vieira Dourado

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2021-07-05
Completion
2022-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789356 on ClinicalTrials.gov