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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-23

Study Completion Date

2018-09-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections Virus Diseases Vaccines Physiological Effects of Drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health Care Professionals

Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.

Seasonal Influenza Vaccine

Intervention Type BIOLOGICAL

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.

Seasonal Influenza Vaccine

Intervention Type BIOLOGICAL

Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute

Interventions

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Seasonal Influenza Vaccine

Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No