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

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: Completed
• Conditions: RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections; Physiological Effects of Drugs; Vaccines
• Intervention / Treatment: Biological: Seasonal Influenza Vaccine

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: Observational
• Enrollment (Actual): 403

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Study Director: Alexander Precioso, MD, PhD, Instituto butantan

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections
• Other Study ID 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