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

Influenza Clinical Trial

— FLU-02-IB  

Official title:

Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819180
• Other study ID #: FLU-02-IB
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: June 29, 2016
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2016
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

Locations

Country	Name	City	State
Brazil	Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No