NCT03392207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 2, 2018

Last Update Submit

January 15, 2019

Conditions

Influenza, HumanOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract InfectionsVirus DiseasesVaccinesPhysiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

  • number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.

    to estimate the incidence of AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.

    42 days post-vaccination

Secondary Outcomes (3)

  • number of solicited AEFI, 14 days post-vaccination.

    14 days post-vaccination

  • number of unsolicited AEFI, 14 days post-vaccination.

    14 days post-vaccination

  • number of unsolicited AEFI, 42 days post-vaccination.

    42 days post-vaccination

Study Arms (2)

Health Care Professionals

Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.

Biological: Seasonal Influenza Vaccine

Elderly

Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.

Biological: Seasonal Influenza Vaccine

Interventions

Seasonal Influenza VaccineBIOLOGICAL

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

ElderlyHealth Care Professionals

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.

You may qualify if:

  • 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).

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Crie - Unifesp

São Paulo, São Paulo, Brazil

Location

Avenida Vital Brasil 1500

São Paulo, 05503-900, Brazil

Location

MeSH Terms

Conditions

Influenza, HumanOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Alexander Precioso, MD, PhD

    Instituto Butantan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 5, 2018

Study Start

April 23, 2018

Primary Completion

July 17, 2018

Study Completion

September 14, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

BR(2)