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

June 29, 2016 updated by: Butantan Institute

Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health adults with age between 18 and 59 years, as well as elderly over 60 years of age may participate in the study. To be included in the study, participants need to meet all inclusion criteria, and not fulfill any exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults group
Healthy men and women between 18 and 59 years of age.
Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine
Other Names:
  • Butantan Influenza vaccine
Elderly group
Elderly over 60 years old.
Biological: Butantan Influenza Trivalent, Fragmented and Inactivated vaccine
Other Names:
  • Butantan Influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events in the first 3 days post vaccination (Safety)
Time Frame: Three days
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)
Time Frame: 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.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butantan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU-02-IB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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