Status:
COMPLETED
Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)
Lead Sponsor:
Butantan Institute
Conditions:
Influenza, Human
Orthomyxoviridae Infections
Eligibility:
All Genders
18-130 years
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Health Care Professional; or
- Elderly (age 60 or more); and
- To have indication to be vaccinated against influenza, according the the Brazilian National Immunazition Programme; and
- To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
- To demonstrates interest to participate in the study as registered in the informed consent form (ICF).
Exclusion
- Known systemic hypersensitivity to eggs or to any component of the vaccine;
- Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination;
- History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination;
- History of Guillain-Barre Syndrome or other demyelinating disease;
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
- Any other condition in the opinion of the investigator that justifies exclusion from participation.
Key Trial Info
Start Date :
April 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 14 2018
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT03392207
Start Date
April 23 2018
End Date
September 14 2018
Last Update
January 16 2019
Active Locations (2)
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1
Crie - Unifesp
São Paulo, São Paulo, Brazil
2
Avenida Vital Brasil 1500
São Paulo, Brazil, 05503-900