Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

A Phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

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).

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.