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

Respiratory Tract Infections Clinical Trial

— FLU-06-IB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392207
• Other study ID #: FLU-06-IB
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: September 14, 2018

Study information

• Verified date: January 2019
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: September 14, 2018
• Est. primary completion date: July 17, 2018
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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;

• Any other condition in the opinion of the investigator that justifies exclusion from participation.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Brazil	Avenida Vital Brasil 1500	Sao Paulo
Brazil	Crie - Unifesp	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of solicited AEFI, 14 days post-vaccination.	to estimate the incidence of solicited AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.	14 days post-vaccination
Secondary	number of unsolicited AEFI, 14 days post-vaccination.	to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.	14 days post-vaccination
Secondary	number of unsolicited AEFI, 42 days post-vaccination.	to estimate the incidence of unsolicited adverse events following immunization (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