Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine (FLU-01-IB)

Inclusion Criteria:

• Healthy adults, male or female aged 18 to 59
• Elderly aged 60 years completed and above
• To be available to participate in the study throughout its duration (approximately 21 days)
• To have medical indication to be vaccinated against influenza
• To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.

Exclusion Criteria:

• Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly)
• Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases
• 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
• Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history
• Known systemic hypersensitivity to eggs or to any component of the vaccine
• 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
• Diagnosis of asthma with a history of hospitalization in the last six months due to illness
• Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination
• Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs within 42 days before study initiation/baseline. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days
• Impaired coagulation due to chronic disease or due to use anticoagulant medication (warfarin or heparin) in the 7 days preceding vaccination
• Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 21 days after vaccination
• Have received influenza vaccine in the past 6 months;
• History of asplenia
• Have received blood products in the past 6 months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the first 21 days after vaccination
• have a counter indication for Influenza vaccination, including allergy to egg proteins
• Use of any investigational product within 42 days before vaccination;
• Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.