Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29); Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).
Intervention description: A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).; A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 6 Months
Maximum age: 71 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a
      more immunogenic and effective response compared with conventional influenza vaccines in
      elderly and adults.

      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6
      to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted
      trivalent influenza vaccine (TIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals of >6 months through <72 months of age on the day of informed consent.

          -  Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed
             consent after the nature of the study has been explained according to local regulatory
             requirements, prior to study entry.

          -  Individuals who can comply with study procedures.

          -  Willingness to allow for serum samples to be stored beyond the study period, for
             potential additional future testing to better characterize immune response.

        Exclusion Criteria:

          -  Progressive, unstable or uncontrolled clinical conditions.

          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study.

          -  History of progressive or severe neurologic disorder, seizure disorder or
             Guillain-Barré syndrome.

          -  Surgery planned during the study period that in the Investigator's opinion would
             interfere with the study visits schedule.

          -  Known bleeding diathesis, or any condition that may be associated with a prolonged
             bleeding time.

          -  Any fatal prognosis of an underlying medical condition (<12 month life expectancy).

          -  Clinical conditions representing a contraindication to intramuscular vaccination and
             blood draws.

          -  Abnormal function of the immune system resulting from:

               1. Clinical conditions.

               2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14
                  consecutive days within 90 days prior to informed consent.

               3. Administration of antineoplastic and immunomodulating agents or radiotherapy
                  within 90 days prior to informed consent.

          -  Received immunoglobulins or any blood products within 180 days prior to informed
             consent.

          -  Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent.

          -  Study personnel as an immediate family or household member.

          -  Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study.

          -  Received any influenza vaccine (licensed or investigational) or with laboratory
             confirmed influenza within 6 months prior enrollment.

          -  Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for
             live vaccines) prior to enrolment in this study or who are planning to receive any
             vaccine within 28 days from the study vaccines.