Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Intervention: Seasonal Influenza Vaccine
Intervention description: This phase II is performed as a multicenter study in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Seasonal Influenza, vaccine

Summary:

      This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza
      Vaccine Administered to Elderly Subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and females volunteers of 65 years of age or older, mentally competent, willing
             and able to give written informed consent prior to study entry.

          -  Individuals able to comply with all the study requirements.

          -  Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

          -  Written informed consent must be obtained for all the subjects before enrollment into
             the study after the nature of the study has been explained.

        Key Exclusion Criteria:

          -  Individuals with any serious chronic or acute disease.

          -  Individuals with history of any anaphylactic reaction and/or serious allergic reaction
             following a vaccination.

          -  Individuals with known or suspected impairment/alteration of immune function.

          -  Individuals with known or suspected history of drug or alcohol abuse.

          -  Individuals with a bleeding diathesis or conditions associated with prolonged bleeding
             time that in the investigator's opinion would interfere with the safety of the
             subject.

          -  Individuals within the past 6 months, they have: had any seasonal or pandemic
             laboratory confirmed influenza disease; received any seasonal or pandemic influenza
             vaccine.

          -  Individuals with any acute or chronic infections requiring systemic antibiotic
             treatment or antiviral therapy within the last 7 days.

          -  Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the
             last 3 days of intended study vaccination.

          -  Individuals participating in any clinical trial with another investigational product 4
             weeks prior to first study visit or intent to participate in another clinical study at
             any time during the conduct of this study.

          -  Individuals who received any other vaccines within 4 weeks prior to enrollment in this
             study or who are planning to receive any vaccine within 4 weeks from the study
             vaccines.

          -  Individuals who are part of study personnel or close family members conducting this
             study.

          -  BMI > 35 kg/m2.