Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V; Inflexal V; Agrippal
Intervention description: Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28; Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus
15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28; Agrippal influenza vaccine
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1356.0
Sex: All
Minimum age: 6 Months
Maximum age: 35 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal
      V is as immunogenic as a locally sourced competitor vaccine in young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥6months to ≤35 months-old healthy children (male or female) born at term after normal
             pregnancy

          -  Recording of medical history and physical examination reveal no abnormality

          -  The parent/legal guardian of the participating child must sign the written informed
             consent and agree to provide a blood sample taken from the child pre- and
             post-immunization

        Exclusion criteria:

          -  Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of
             the vaccine

          -  Previous vaccination against influenza

          -  At time of enrollment, presentation of clinical symptoms of active infection and/or
             body temperature ≥38°C

          -  Confirmation or suspicion of immunosuppressed status (including cancer), or
             confirmation of immunodeficiency disease (congenital or acquired including HIV)

          -  Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs
             including systemic steroids during the last 3 months before immunization or at
             present, as follows: long-term oral prednisone or other equivalent steroid:
             ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the
             study is allowed)

          -  Treatment with immunoglobulins or blood products during the last 3 months before
             immunization or such treatment scheduled during the study

          -  Participation in other clinical trials during the last 3 months before immunization or
             intention to participate during this study period

          -  At present or during the last 6 months before immunization: radiotherapy or treatment
             with cytotoxic drugs

          -  Other vaccination with a killed vaccine within 14 days before immunization or with an
             attenuated vaccine within 28 days before immunization (note: after subject inclusion
             vaccines of the immunization program for children are allowed upon the physician's
             discretion. However, immunization on the same day must be avoided)

          -  Family history of Guillain-Barré Syndrome

          -  Severe congenital deficiency or disease

          -  Antecedent of neurological disease or epileptic attack

          -  Severe cardiopulmonary disease with possibility to influence the study result

          -  Disturbance of coagulation or under anticoagulant treatment, likely to be
             contraindicated to i.m. injection

          -  Suspected non-compliance