NCT04789356

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

Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6,233 (actual)
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Adsorbed SARS-CoV-2 (inactivated) vaccine	600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-07-05
• Completion: 2022-03-01
• First posted: 2021-03-09
• Last updated: 2021-07-26

Locations

1 site across 1 country: Brazil