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Clinical trial

Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine

ID
Name
CFV-01-IB
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.
Trial arms
Trial start
2021-05-10
Estimated PCD
2023-03-12
Trial end
2023-03-13
Status
Completed
Treatment
Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
Arms:
General population 60 and 74 years old, General population 75 years old or more, Health care professionals between 18 and 59 years old
Size
2549
Primary endpoint
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
7 days after each dose of the vaccine
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group
7 days after each dose of the vaccine
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 2549, 'type': 'ACTUAL'}}
Updated at
2023-05-22

1 organization

1 product

1 indication

Organization
Butantan Institute
Product
Adsorbed COVID-19 Vaccine
Indication
COVID-19