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

Sponsor

Butantan Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03392207

Collaborator

(none)

403

Enrollment

Locations

4.7

Actual Duration (Months)

201.5

Patients Per Site

42.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections Virus Diseases Vaccines Physiological Effects of Drugs	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 Design

Study Type:

Observational

Actual Enrollment :

403 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 23, 2018

Actual Primary Completion Date :

Jul 17, 2018

Actual Study Completion Date :

Sep 14, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

number of participants with adverse events following immunization (AEFI), 42 days post-vaccination. [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.

Secondary Outcome Measures

number of solicited AEFI, 14 days post-vaccination. [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.
number of unsolicited AEFI, 14 days post-vaccination. [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.
number of unsolicited AEFI, 42 days post-vaccination. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

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.