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

Study Overview
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Brief Summary
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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.

Detailed Description
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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..

Official Title
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Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal

Conditions
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Influenza

Intervention / Treatment
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* Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adults group<br>Healthy men and women between 18 and 59 years of age. | Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine<br> <br> * Other names: Butantan Influenza vaccine;|
| Elderly group<br>Elderly over 60 years old. | Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine<br> <br> * Other names: Butantan Influenza vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events in the first 3 days post vaccination (Safety) | Solicited and unsolicited local and systemic adverse reactions reported by the participants until Day 3 after vaccination. | Three days | 
| Antibody response to each of the vaccine strains 21 days post vaccination (Immunogenicity) | Antibody response to each of the vaccine´s strains as measured by: % seroconversion and/or increase in the geometric mean of hemagglutination inhibition (HAI) titers and/or % seroprotection. | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza