Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018) (FLU-06-IB)

January 15, 2019 updated by: Butantan Institute

Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (2018 Southern Hemisphere Season) Produced at Butantan Institute

Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV).

Objetive: To conduct an active surveillance study focusing on the elderly and health care professionals as part of Butantan pharmacovigilance plan, while passive surveillance activities will continue. The pharmacovigilance plan, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of IB TIV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: healthcare workers and elderly (people over 60 years old). Study Size: A total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
403

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
      • Sao Paulo, Brazil, 05503-900
        • Avenida Vital Brasil 1500
    • São Paulo
      • Sao Paulo, São Paulo, Brazil
        • Crie - Unifesp

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.

Description

Inclusion Criteria:

  • Health Care Professional; or
  • Elderly (age 60 or more); and
  • To have indication to be vaccinated against influenza, according the the Brazilian National Immunazition Programme; and
  • To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
  • To demonstrates interest to participate in the study as registered in the informed consent form (ICF).

Exclusion Criteria:

  • Known systemic hypersensitivity to eggs or to any component of the vaccine;
  • Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination;
  • History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination;
  • History of Guillain-Barre Syndrome or other demyelinating disease;
  • 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;
  • Any other condition in the opinion of the investigator that justifies exclusion from participation.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Health Care Professionals
Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute
Elderly
Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.
Time Frame: 42 days post-vaccination
to estimate the incidence of AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
42 days post-vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of solicited AEFI, 14 days post-vaccination.
Time Frame: 14 days post-vaccination
to estimate the incidence of solicited AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
14 days post-vaccination
number of unsolicited AEFI, 14 days post-vaccination.
Time Frame: 14 days post-vaccination
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
14 days post-vaccination
number of unsolicited AEFI, 42 days post-vaccination.
Time Frame: 42 days post-vaccination
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
42 days post-vaccination

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Butantan Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alexander Precioso, MD, PhD, Instituto butantan

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FLU-06-IB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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