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

Butantan Institute

Status

Completed

Conditions

Influenza, Human

Physiological Effects of Drugs

RNA Virus Infections

Vaccines

Orthomyxoviridae Infections

Virus Diseases

Respiratory Tract Infections

Treatments

Biological: Seasonal Influenza Vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT03392207

FLU-06-IB

Details and patient eligibility

About

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.

Full 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.

Enrollment

403 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

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.