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Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute (FLU-05-IB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03057483
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Influenza Vaccines Biological: Seasonal Influenza vaccine

Detailed Description:

Primary objective: to characterize and estimate the incidence of solicited adverse events following immunization (AEFI) associated with administration of the trivalent influenza vaccine produced at Butantan Institute (TIV).

Secondary objectives: 1) to characterize and estimate the incidence of overall (solicited and unsolicited) AEFI associated with administration of TIV; 2) to characterize and estimate the incidence of unsolicited AEFI associated with administration of TIV.

Study Design: This is a prospective cohort study aimed at identifying and evaluating adverse events following immunization among individuals vaccinated with TIV during the national immunization campaign. The design will include active surveillance by phone contact and through visits to the study site. Health facilities will be designated and set up as sentinel sites to enroll individuals being vaccinated with IB TIV for active follow up of solicited AEFI occurring within the first 14 days post-vaccination, and unsolicited AEFI up to 6 weeks post-vaccination.

Population: The following groups are targeted groups for the national immunization campaign and will be recruited for participation in this study:

  • 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).

Variables: Solicited AEFI to be monitored will include local reactions (erythema, pain, swelling, ecchymosis, pruritus and induration), systemic reactions (headache, fever, malaise, arthralgia, myalgia, rash, chills, pruritus, fatigue, sweating) and irritability and persistent crying (for children than 6 years). Unsolicited AEFI reported over the period up to 6 weeks post-vaccination will be recorded. All adverse events reported in the study will be MedDRA coded. Other variables of interest in the study are demographic information of study participants: date of birth, gender, age, ethnicity, as well as vaccination information including date of immunization, site, and vaccine lot.

Data Sources: Study information including signs and symptoms following immunization with TIV will be recorded daily for 14 days post immunization, and will be recorded in the participant's study file.

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, will be enrolled in the study by study staff.

Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate. Incidence rates (IR) of AEFI with TIV will be calculated as the number of events divided by the total number of participants exposed to TIV in each of the targeted groups over the period of follow up. IR will be calculated based on total person time of follow-up, 95% confidence intervals will be calculated.


Study Design

Study Type : Observational
Actual Enrollment : 533 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (Split Virion and Inactivated) Produced at Butantan Institute
Actual Study Start Date : April 6, 2017
Primary Completion Date : September 6, 2017
Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Elderly
People over 60 years of age. seasonal influenza vaccine
Biological: Seasonal Influenza vaccine
Seasonal Influenza vaccine
Other Name: Flu vaccine
Health care workers
People working in health care services seasonal influenza vaccine
Biological: Seasonal Influenza vaccine
Seasonal Influenza vaccine
Other Name: Flu vaccine
Pregnant women
Pregnant women seasonal influenza vaccine
Biological: Seasonal Influenza vaccine
Seasonal Influenza vaccine
Other Name: Flu vaccine
Post partum women
Women who have given birth < 45 days seasonal influenza vaccine
Biological: Seasonal Influenza vaccine
Seasonal Influenza vaccine
Other Name: Flu vaccine
Children
Children from 6 months to 5 years of age seasonal influenza vaccine
Biological: Seasonal Influenza vaccine
Seasonal Influenza vaccine
Other Name: Flu vaccine


Outcome Measures

Primary Outcome Measures :
  1. Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute [ Time Frame: study period follow up, approximately 6 months ]
    Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute


Secondary Outcome Measures :
  1. Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute [ Time Frame: study period follow up, approximately 6 months ]
    Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute

  2. Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute [ Time Frame: study period follow up, approximately 6 months ]
    Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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).

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057483


Locations
Brazil
UBS Buritis
Boa Vista, Roraima, Brazil, 69304000
Crie - Unifesp
Sao Paulo, São Paulo, Brazil
Sponsors and Collaborators
Butantan Institute
Investigators
Principal Investigator: Lily Weckx, MD Federal University of São Paulo
More Information

Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT03057483     History of Changes
Other Study ID Numbers: FLU-05-IB
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs