Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: SIIL LAIV (live, trivalent seasonal influenza vaccine); Placebo
Intervention description: Dose: 0.5 mL, The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season; Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 309.0
Sex: All
Minimum age: 24 Months
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccines; Influenza, Human; Live Attenuated Influenza Vaccine

Summary:

      In this Phase II randomized controlled clinical trial, generally healthy male and female
      children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh.
      The study is expected to continue for at least 6 months following vaccination. The
      experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live
      Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to
      WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is
      administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable
      sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited
      in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in
      appearance to the active vaccine.

      The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24
      through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among
      children receiving study vaccine as compared to children receiving placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female child at least 24 months of age and no older than 59 months of
             age at the time of study vaccination

          -  A child whose parent or guardian's primary residence, at the time of study
             vaccinations, is within the Kamalapur surveillance site catchment area and who intends
             to be present in the area for the duration of the trial

          -  A child whose parent or legal guardian is willing to provide written informed consent
             prior to the participant's study vaccination

        Exclusion Criteria:

          -  Has any serious chronic disease including progressive neurologic disease,
             tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected
             disease of the immune system

          -  Is receiving immunosuppressive agents including systemic corticosteroids during the
             two weeks prior to study vaccination

          -  Has a history of documented hypersensitivity to eggs or other components of the
             vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with
             life-threatening reactions to previous influenza vaccinations

          -  Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks
             before

          -  Lives in household with somebody currently participating in a respiratory vaccination
             or antiviral study

          -  Has current or past participation (within 2 months of trial enrollment visit) in any
             clinical trial involving a drug or biologic with activity against respiratory disease

          -  Has any condition determined by investigator as likely to interfere with evaluation of
             the vaccine or be a significant potential health risk to the child