MedTrace Logo

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

NCT03392207 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 403

Last updated 2019-01-16

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Seasonal Influenza Vaccine

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

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Alexander Precioso, MD, PhD · Instituto Butantan

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2018-07-17
Completion
2018-09-14

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03392207 on ClinicalTrials.gov