Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty
      infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28
      days apart but no more than 42 days apart. Preservative-free Fluzone® will not be
      administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample
      will be obtained prior to the first vaccination, approximately 4 weeks after the second
      vaccination and 6 months after the second vaccination for the measurement of immune response.
      The primary purpose of this study is twofold: 1.) To determine the safety of administering
      two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability
      of inducing an immune response of administering two doses of preservative-free Fluzone® to
      young infants.
    

Detailed description: 
      Influenza virus is an important global cause of morbidity and mortality. Influenza A or B
      viruses cause epidemics of disease almost every winter in the United States with an average
      of 36,000 deaths and 114,000 hospitalizations each year during 1990s (superscript 1).
      Children have the highest rates of infection while adults greater than 50 years of age have
      the highest mortality rates (superscript 2). Influenza, however, is associated with
      hospitalizations in young infants. In a survey of the Tennessee Medicaid database over many
      years, Neuzil et. al reported hospitalization rates in children less than 6 months of age
      that were much higher than in older children, and the rates approached those over 65 years of
      age (superscript 3). This is a prospective, phase l, open-label, self-contained, four visits
      over a period of 7 months, pilot study of 50 healthy infants, aged 10-22 weeks, with history
      of up-to-date routine immunizations, to assess safety and immunogenicity of administering 2
      pediatric doses (with a minimum 4 weeks apart) of 0.25 ml of trivalent Influenza vaccine
      (Fluzone®). Each of the 50 infants will receive two 0.25mL doses of preservative free
      Fluzone®, given a minimum of 28 days apart but no more than 42 days apart. Preservative-free
      Fluzone® will not be administered at the same time as other routine vaccines. Approximately
      2-3 mLs of venous blood will be obtained prior to the first vaccination, approximately 4
      weeks after the second vaccination and 6 months after the second vaccination for the
      measurement of neutralization and HAI titers. Infants will be closely monitored during the
      influenza season for respiratory symptoms, fever, or other influenza-like illnesses. They
      will be seen during these episodes and nasal washes will be collected for a viral screen that
      will include culture for influenza virus, respiratory syncytial virus (RSV), adenovirus and
      parainfluenza virus and rapid test for influenza and RSV. Blood collected at the follow up
      visit, 6 months after the second dose of Fluzone®, will be used to measure post season
      antibody titers to strains of influenza A and B.
    

Intervention name(s): Fluzone
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza, Vaccine, Infants