Clinical trial NCT03392207: Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)
Official title: Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (2018 Southern Hemisphere Season) Produced at Butantan Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Virus Diseases
Vaccines
Physiological Effects of Drugs
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2018-01-05
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.
timeFrame: 42 days post-vaccination
Secondary outcomes:
measure: number of solicited AEFI, 14 days post-vaccination.
timeFrame: 14 days post-vaccination
measure: number of unsolicited AEFI, 14 days post-vaccination.
timeFrame: 14 days post-vaccination
measure: number of unsolicited AEFI, 42 days post-vaccination.
timeFrame: 42 days post-vaccination
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Crie - Unifesp
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Avenida Vital Brasil 1500
Study officials:
affiliation: Instituto Butantan
name: Alexander Precioso, MD, PhD
role: STUDY_DIRECTOR
References: