Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)

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.

Inclusion criteria

• 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 criteria

• 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.