Influenza Clinical Trial
Official title:
Evaluation of the Effect of Age and Prior Immunity on the Response to Live or Inactivated Seasonal (A/California/7/2009-like (2009 H1N1), A/Perth/16/2009-like (H3N2), and B/Brisbane/60/2008-like (B/Victoria Lineage) Influenza Vaccines in Children
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.
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 and IgG 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 and TCID50 on MDCK cells.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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