Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Adjuvanted trivalent inactivated subunit influenza vaccine; Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine; Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Intervention description: Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.; For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.; Meningococcal vaccine: two IM injections
Tick-borne encephalitis vaccine: two IM injections
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4902.0
Sex: All
Minimum age: 6 Months
Maximum age: 71 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; vaccine; children

Summary:

      This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5
      mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza
      and non-adjuvanted influenza control vaccines in subjects 6 to <72 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children whose parents/legal guardians have given written informed consent prior to
             study entry: a) aged 6 to <72 months (Part I and II of the study; influenza seasons
             2007/2008 and 2008/2009) b) aged 6 to <36 months (Part III of the study; influenza
             season 2009/2010)

          -  In good health as determined by: a) medical history, b) physical examination, c)
             clinical judgment of the investigator

        Exclusion criteria:

          -  Administration of licensed vaccines (including H1N1sw vaccines) within 14 days (for
             inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this
             study. Routine vaccines, according to local recommendations, or any other vaccines not
             foreseen in the protocol could be given after the active trial phase (i.e., 21 days
             after last vaccination) has been concluded.

          -  Receipt of another investigational vaccine or any investigational agent within 30 days
             prior to enrollment in the study or before completion of the safety follow-up period
             in another study, whichever is longer, and participation in another clinical trial
             during the present study.

          -  Experience of a severe acute infectious disease in the month prior to study start or
             experience of a mild acute infection disease in the week prior the study start
             (untreated common cold is acceptable). The severity of the infectious disease occurred
             will be based on the investigator's judgment.

          -  Any severe acute respiratory disease and infection requiring systemic antibiotic or
             antiviral therapy ongoing or resolved within 2 days prior to study start.

          -  Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature
             equal to or greater than 38.3°C) within the 2 days before enrollment.

          -  Any serious disease in the opinion of the investigator including, for example: a)
             cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive
             therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma
             under inhalative therapy only is acceptable, e) acute or progressive hepatic disease,
             f) acute or progressive renal disease.

          -  Known or suspected impairment/alteration of immune function, for example, resulting
             from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or
             inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt
             of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
             within the past 90 days and for the full length of the study, d) high risk for
             developing an immunocompromising disease (suspected or known HIV infection or
             HIV-related disease).

          -  Bleeding diathesis.

          -  History of hypersensitivity to any component of the study medication or chemically
             related substances.

          -  History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg
             products or any other vaccine component.

          -  Laboratory confirmed influenza disease.

          -  History of neurological disorder or seizures (febrile seizures allowed).

          -  Received any influenza vaccine.

          -  Major surgery planned during the study period.

          -  Any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives, e.g., planned travel or relocation of residence
             that would interfere with completion of study.