Status:
UNKNOWN
Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity
Lead Sponsor:
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Collaborating Sponsors:
Butantan Institute
Conditions:
Covid19
Eligibility:
All Genders
18-49 years
Phase:
PHASE4
Brief 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 comorb...
Eligibility Criteria
Inclusion
- Age between 18 and 49 years
- Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.
Exclusion
- Prior vaccination for COVID-19;
- Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
- History of severe allergic reaction or anaphylaxis to study vaccine components;
- Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
- Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
- Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
- Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
6233 Patients enrolled
Trial Details
Trial ID
NCT04789356
Start Date
March 18 2021
End Date
March 1 2022
Last Update
July 26 2021
Active Locations (1)
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1
Escola Normal Superior - Universidade do Estado do Amazonas
Manaus, Amazonas, Brazil, 69050-010