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

Completed

• Conditions: Influenza
• Interventions: Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

• Registration Number: NCT02819180
• Lead Sponsor: Butantan Institute

Brief Summary

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

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..

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly group	Butantan Influenza Trivalent, Fragmented and Inactivated vaccine	Elderly over 60 years old.
Healthy adults group	Butantan Influenza Trivalent, Fragmented and Inactivated vaccine	Healthy men and women between 18 and 59 years of age.

Primary Outcome Measures

Name	Time	Method
Adverse events in the first 3 days post vaccination (Safety)	Three days	Solicited and unsolicited local and systemic adverse reactions reported by the participants until Day 3 after vaccination.
Antibody response to each of the vaccine strains 21 days post vaccination (Immunogenicity)	21 days	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.

Trial Locations

Locations (1)

Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil