Comparison of Flu Vaccine Doses in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the possibility that giving an increased dose of flu
      vaccine to children 6 through 35 months of age will improve protection against influenza
      without increasing side effects. Investigators will evaluate the body's response to the
      vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine,
      and those ages 12-35 months, who have been previously vaccinated, will participate in the
      study for about 7 months. Vaccine naïve study participants will receive two doses of flu
      vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated
      subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL
      dose (Group 2). Study procedures include physical examination, memory aids, blood sampling
      and a follow-up phone call about 6 months after the last vaccine dose.
    

Detailed description: 
      Influenza is an important cause of morbidity and mortality among both children and adults.
      Influenza A and/or B viruses cause yearly epidemics in the United States with an average of
      36,000 deaths and 114,000 hospitalizations annually. Children have the highest rates of
      infection. Influenza is also associated with substantial numbers of hospitalizations among
      young infants. Because of the limited data available and the variability of reported
      seroresponses to doses of 0.25 ml in children 6-35 months of age, investigators hypothesize
      that a higher dose will be more consistently immunogenic. In addition, since currently
      licensed trivalent inactivated influenza (TIV) vaccines are well tolerated with minimal
      systemic and local adverse events, investigators hypothesize that administering a higher dose
      of 0.5 ml to this age group will be well-tolerated. Therefore, investigators propose to
      compare the safety and immunogenicity of 0.25 ml doses of TIV to that of 0.5 ml doses of TIV
      when administered to children 6-35 months of age. The proposed study is a phase I, two-arm,
      1:2 randomized, double-blinded trial comparing the safety and immunogenicity of increased
      dose(s) (0.5 ml) with standard dose (0.25 ml) of TIV in children 6-35 months of age with and
      without a history of previous TIV vaccination. The population will include a Naïve Cohort:
      270 healthy male and female children who are 6-35 months of age and have never received an
      influenza vaccination; and a Fully Primed Cohort: 60 healthy male and female children who are
      12-35 months of age and have received two doses of 2009-2010 H1N1 and two doses of TIV at
      anytime in the past as defined for purposes of this study. Either a standard pediatric dose
      (0.25 ml) or a larger dose (0.5 ml) of TIV will be administered intramuscularly in the
      anterolateral thigh with a 25 gauge 1" needle. The primary objective is to evaluate the
      safety of administering an increased dose(s) (0.5 ml) of TIV to children 6-35 months of age
      as compared to standard dose(s) (0.25 ml) of TIV. The secondary objective is to compare the
      humoral immune responses to TIV antigens in children 6-35 months of age who receive the
      increased dose(s) of TIV to those who receive the standard dose(s) of TIV.
    

Intervention name(s): Trivalent Inactivated Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) (Fluzone®) administered intramuscularly (IM) in the thigh with a 25 gauge 1 inch needle. Naive cohort (enrolled over two influenza seasons (2010-11 and 2011-12)) will receive vaccine in two IM doses 28-42 days apart, Fully Primed cohort (enrolled in one influenza season (2010-11)) will receive vaccine in one IM dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, pediatric, vaccine