Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine - FLU-02-IB

Butantan Institute

Status

Completed

Conditions

Influenza

Treatments

Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT02819180

FLU-02-IB

Details and patient eligibility

About

Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.

Full description

Prospective cohort study to assess safety of one dose of theButantan Influenza vaccine (Fragmented and Inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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