NCT03392207

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 403 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal Influenza Vaccine	Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-07-17
• Completion: 2018-09-14
• First posted: 2018-01-05
• Last updated: 2019-01-16

Locations

2 sites across 1 country: Brazil