Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV); Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Intervention description: one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm; one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 7109.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Elderly; Influenza; Immunogenicity; Safety; Adjuvant; Adjuvanted; Adjuvants; Vaccines

Summary:

      The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted
      subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing
      process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with
      respect to immunogenicity in subjects aged 65 years and older. The active comparator
      non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United
      States and will be used to provide a comparative assessment for immunogenicity and safety.
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females subjects aged ≥65 years at day of vaccination who are willing and able to
        comply to study procedures.

        Exclusion Criteria:

          1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with
             a history of any illness that,in the opinion of the investigator, would have
             interfered with the subject's ability to participate in the study.

          2. Individuals who were not able to comprehend and/or follow all required study
             procedures for the whole period of the study.

          3. Known or suspected impairment/alteration of immune function.

          4. Individuals with a known bleeding diathesis.

          5. History of Guillain-Barré syndrome.

          6. Individuals with history of allergy to vaccine components and/or a history of any
             anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral
             proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone,
             thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/
             nonoxynol-9 (spermicide).

          7. Receipt of another investigational agent within 30 days prior to enrollment in the
             study or before completion of the safety follow-up period in another study.

          8. Individuals who had received any other vaccines within 2 weeks for inactivated
             vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had
             planned to receive any vaccine within 3 weeks from the study vaccine.

          9. Individuals who had received vaccination against seasonal influenza in the previous 6
             months.

         10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.

         11. Individuals with history of substance or alcohol abuse within the past 2 years.

         12. Individuals providing consent who did not consent to the retention of their serum
             samples after study completion.

         13. Elective surgery or hospitalization planned to occur during the treatment phase or
             during the follow-up phase that, according to the opinion of the investigator, might
             have poses additional risk to the subject.

         14. Subjects from whom blood could not be drawn at visit 1.