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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Biological: Seasonal Influenza Vaccine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health Care Professionals<br>Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. | Biological: Seasonal Influenza Vaccine<br>* Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute<br>|
| Elderly<br>Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. | Biological: Seasonal Influenza Vaccine<br>* Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events following immunization (AEFI), 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of solicited AEFI, 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. | 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. | 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 |