Status:
COMPLETED
Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
Lead Sponsor:
Butantan Institute
Conditions:
SARS-CoV-2 Acute Respiratory Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
Detailed Description
. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan. * The...
Eligibility Criteria
Inclusion
- Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
- Informed consent form signed by participant.
- Show voluntary intention to participate in the study and availability throughout the study.
Exclusion
- History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
- History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
- Be unavailable during the study period.
- Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
2549 Patients enrolled
Trial Details
Trial ID
NCT04845048
Start Date
May 10 2021
End Date
March 13 2023
Last Update
May 22 2023
Active Locations (3)
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1
Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
Botucatu, São Paulo, Brazil
2
Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado.
Ribeirão Preto, São Paulo, Brazil
3
Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
São Paulo, Brazil