NCT03057483: FLU-05-IB

Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute

Completed Last updated 17 January 2018

What this trial tests

trial testing Seasonal Influenza vaccine in Influenza Vaccines in 533 participants. Completed in 6 December 2017.

Timeline

6 April 2017

Primary endpoint
6 September 2017

6 December 2017

Quick facts

Lead sponsor	Butantan Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	533
Start date	6 April 2017
Primary completion	6 September 2017
Estimated completion	6 December 2017
Sites	2 locations across Brazil

Drugs / interventions tested

• Seasonal Influenza vaccine — full drug profile →

Conditions studied

• Influenza Vaccines — all drugs for Influenza Vaccines →

Sponsor

Butantan Institute

Who can join

Adults 6 Months to 59, any sex, with Influenza Vaccines. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance data on TIV, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of TIV.

Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: children between six months and five years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.

Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017.
   Gattás VL, Braga PE, Koike ME, Lucchesi MBB, et al · · 2018 · cited 8× · PMID 30570077 · DOI 10.1590/s1678-9946201961004
2. Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups.
   Vanni T, Thomé BDC, Oliveira MMM, Gattás VL, et al · · 2021 · PMID 33571237 · DOI 10.1371/journal.pone.0246540