An observational study in Influenza, Human, Orthomyxoviridae Infections and RNA Virus Infections, sponsored by Butantan Institute. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Butantan Institute · Observational
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.
People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.
Exclusion Criteria:
Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute
number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.
to estimate the incidence of AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
Time frame: 42 days post-vaccination
number of solicited AEFI, 14 days post-vaccination.
to estimate the incidence of solicited AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
Time frame: 14 days post-vaccination
number of unsolicited AEFI, 14 days post-vaccination.
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
Time frame: 14 days post-vaccination
number of unsolicited AEFI, 42 days post-vaccination.
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
Time frame: 42 days post-vaccination
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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