Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute
Condition: Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Observational

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.
    

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.
    

Intervention name(s): Seasonal Influenza vaccine
Intervention type(s): Biological
Intervention description(s): Seasonal Influenza vaccine
Other intervention name(s): Flu vaccine
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
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.