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

NCT03057483 | Completed

• 1 other identifier: FLU-05-IB
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Influenza Vaccines

Outcome Measures

Primary Outcomes (1)

• Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute

  Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute

  study period follow up, approximately 6 months

Secondary Outcomes (2)

• Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute

  study period follow up, approximately 6 months

• Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute

  study period follow up, approximately 6 months

Study Arms (5)

Elderly

People over 60 years of age. seasonal influenza vaccine

Biological: Seasonal Influenza vaccine

Health care workers

People working in health care services seasonal influenza vaccine

Biological: Seasonal Influenza vaccine

Pregnant women

Pregnant women seasonal influenza vaccine

Biological: Seasonal Influenza vaccine

Post partum women

Women who have given birth \< 45 days seasonal influenza vaccine

Biological: Seasonal Influenza vaccine

Children

Children from 6 months to 5 years of age seasonal influenza vaccine

Biological: Seasonal Influenza vaccine

Interventions

Seasonal Influenza vaccine BIOLOGICAL

Seasonal Influenza vaccine

Also known as: Flu vaccine

Children; Elderly; Health care workers; Post partum women; Pregnant women

Eligibility Criteria

• Age: 6 Months - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People eligible for immunization with seasonal influenza vaccine as described: children aged 6m-5y, elderly, health care workers, pregnant and post partum women.

You may qualify if:

• Children between six months and five years old; or
• Pregnant and postpartum women (mothers until 45 days after birth); or
• Health care workers; or
• Elderly (aged 60 years or more); and
• To have indication to be vaccinated against influenza;
• To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
• 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;

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (2)

UBS Buritis

Boa Vista, Roraima, 69304000, Brazil

Location

Crie - Unifesp

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• Gattas VL, Braga PE, Koike ME, Lucchesi MBB, Oliveira MMM, Piorelli RO, Queiroz V, Precioso AR. Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017. Rev Inst Med Trop Sao Paulo. 2018 Dec 20;61:e4. doi: 10.1590/S1678-9946201961004.

  PMID: 30570077 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Lily Weckx, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 20, 2017
• Study Start: April 6, 2017
• Primary Completion: September 6, 2017
• Study Completion: December 6, 2017
• Last Updated: January 17, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)