Immunogenicity and Safety of Different Doses of Fluzone® Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out if giving the smaller dose of flu vaccine
      under the skin generates antibodies against flu compared to giving the vaccine the usual way,
      as a shot in the arm. If using smaller doses in this manner is effective, the current supply
      of vaccine could be used to make more doses to give to more people. About 217 healthy adults,
      18 to 49 years of age, will participate. The study will be conducted at one site in the
      United States and subjects are expected to participate for about 6 months. Blood samples will
      be taken to assess the immune system response. Local and systemic safety will be evaluated in
      the 28 days following vaccination.
    

Detailed description: 
      This study is a randomized, prospective, active-controlled, single-center, open label,
      dose-ranging clinical trial of TIV (Fluzone®) administered to healthy 18-to-49 year old
      adults who did not receive 2003-2004, 2004-2005 and 2005-2006 influenza vaccine. Subjects
      will be randomized to one of 7 groups (4 intramuscular and 3 intradermal) to compare the
      immunogenicity and safety of different concentrations of the standard Fluzone® administered
      intradermally using the Mantoux technique to that of standard Fluzone® administered
      intramuscularly. The primary objective of the study is to compare the immunogenicity of
      injected Fluzone® across different dose levels and different routes of administration. The
      secondary objectives are to describe the number and proportions of subjects in each group
      experiencing any injection site or systemic symptoms and the proportion of subjects who
      experience moderate-to-severe symptoms post vaccination. Approximately 31 subjects per group
      (217 in total) will be enrolled with each group determined by dose and route of
      administration of vaccines. Subjects will be observed in the clinic for at least 30 minutes
      after immunization and will maintain a memory aid to record daily oral temperature and any
      systemic and local reactions for 7 days after the day of immunization. Subjects will be
      contacted by phone between 8 to 12 days after immunization to review their 7-day memory aid,
      including the assessment of their recorded daily oral temperature, any local or systemic
      reactions, and the occurrence of any other AEs and SAEs. Subjects will return at 28 (+/- 3)
      days after immunization to assess the occurrence of unsolicited AEs and SAEs and complete an
      acceptability and functional skill questionnaire. Serum for immunogenicity evaluations will
      be obtained prior to the first vaccination and approximately 28 (+/- 3) days post
      vaccination. The 2005-2006 formulation will be used for all seven groups.
    

Intervention name(s): Fluzone® (IM); Fluzone®
Intervention type(s): Biological; Biological
Intervention description(s): 15, 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by the standard intramuscular route.; 9, 6, or 3 mcg of standard trivalent inactivated influenza vaccine (TIV) administered by intradermal route (Mantoux technique).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza