Respiratory Tract Infections Clinical Trial
Official title:
Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (2018 Southern Hemisphere Season) Produced at Butantan Institute
Rationale and Background: Since 2013, Butantan Institute has been performing passive
pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine
(IB TIV).
Objetive: To conduct an active surveillance study focusing on the elderly and health care
professionals as part of Butantan pharmacovigilance plan, while passive surveillance
activities will continue. The pharmacovigilance plan, via active surveillance, is being
implemented in response to WHO requirements for pre-qualification of IB TIV.
Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: healthcare workers and elderly (people over 60 years old). Study Size: A total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent. ;
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