Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose
      schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or
      licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed
      by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1
      infection will be excluded.
    

Detailed description: 
      The study will be conducted as a randomized, prospective, open-label evaluation of the
      clinical tolerability, vaccine virus shedding, and serum and mucosal antibody response to
      vaccination with either live trivalent influenza vaccine (LAIV) or trivalent influenza
      vaccine (TIV) in healthy children between the ages of 2 and 9 years. Children will be
      screened for antibody to A/Brisbane/57/07 (H1N1) and A/California/07/09 (H1N1),
      A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 before and at indicated times after the start
      of the study. They will not be randomized based on antibody levels. Children with prior
      documented infection with the 2009 pandemic H1N1 virus will be excluded. Vaccine will be
      administered on days 0 and 28.

      Safety of vaccination will be assessed using symptoms collected by parents for 7 days after
      each dose of vaccine. Serum will be obtained prior to and on day 28 following each dose of
      vaccine and assessed for antibody by HAI, ELISA, and neutralization techniques. Nasal
      secretions will be obtained by nasal wick prior to and on day 28 after each dose and assessed
      for HA-specific IgA (immune globulin A) and IgG (immune globulin G)antibody by ELISA. Nasal
      swabs will be obtained on days 2, 4, and 7 after each dose of live vaccine and assessed for
      the presence and magnitude of vaccine virus shedding of the live attenuated vaccine by
      rtRT-PCR (real-time reverse transcriptase polymerase chain reaction)and TCID50 (50% tissue
      culture infectious doses)on MDCK(Madin Darby Canine Kidney) cells.
    

Intervention name(s): Live attenuated Influenza vaccine; Trivalent Influenza Vaccine; TIV followed by LAIV; LAIV followed by TIV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days; .25 mL given intramuscularly to children 24 to 36 months of age, 2 doses given 28 days apart, .5 mL given intramuscularly to children 37 months to 9 years of age, 2 doses given 28 day s apart.; TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later; LAIV .2 mL given through nasal spray (.1 mL in each nostril) Followed by TIV .25 mL given intramuscularly to children 24 to 25 months of age or .5 mL given intramuscularly to children 36 months to 9 years of age 28 days later
Other intervention name(s): FluMist; Seasonal Influenza Vaccine; Seasonal Influenza Vaccines; Seasonal Influenza Vaccines
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza; A/California/7/2009-like (2009 H1N1); A/Perth/16/2009-like (H3N2); B/Brisbane/60/2008-like (B/Victoria lineage)