Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults Aged 18 Years and Above
Condition: Human; Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent influenza virus vaccine (TIVf)
Intervention description: A single dose (0.5 mL) of vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Interpandemic influenza; Adult; Elderly; Safety; Tolerability; Immunology

Summary:

      This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity
      of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg
      derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety
      and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining
      marketing approval of the vaccine formulation intended for use prior to the next influenza
      season in the Northern Hemisphere.

      The antibody response to each influenza vaccine antigen, was measured by hemagglutination
      inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization
      in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM)
      injection of the vaccine was evaluated in compliance with the requirements of the current EU
      recommendations for clinical trials related to yearly licensing of influenza vaccines
      (CPMP/BWP/214/96).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female volunteers of 18 years of age or older, mentally competent, were
             willing and gave written informed consent prior to study entry;

          2. Individuals who complied with all the study requirements;

          3. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

        Exclusion Criteria:

          1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, could have interfered with the subject's ability to
             participate in the study.

          2. Individuals with any serious chronic or acute disease (in the judgment of the
             investigator), including but not limited to:

               -  Medically significant cancer (except for benign or localized skin cancer, cancer
                  in remission for ≥10 years or localized prostate cancer that has been clinically
                  stable for more than 2 years without treatment);

               -  Medically significant advanced congestive heart failure (i.e., NYHA class III and
                  IV);

               -  Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV);

               -  Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's
                  thyroiditis that has been clinically stable for ≥5 years);

               -  Diabetes mellitus type I;

               -  Poorly controlled diabetes mellitus type II;

               -  Advanced arteriosclerotic disease;

               -  History of underlying medical condition such as major congenital abnormalities
                  requiring surgery, chronic treatment, or associated with developmental delay
                  (e.g., Down's syndrome);

               -  Acute or progressive hepatic disease;

               -  Acute or progressive renal disease;

               -  Severe neurological (es. Guillain-Barré syndrome) or psychiatric disorder;

               -  Severe asthma.

          3. Individuals with history of any anaphylactic reaction and/or serious allergic reaction
             following a vaccination, a proven hypersensitivity to any component of the study
             vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken
             feathers, influenza viral protein, kanamycin and neomycin sulphate).

          4. Individuals with known or suspected (or had a high risk of developing)
             impairment/alteration of immune function (excluding that normally associated with
             advanced age) resulting, for example, from:

               -  receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or
                  cancer chemotherapy/radiotherapy) within the past 60 days and for the full length
                  of the study;

               -  receipt of immunostimulants;

               -  receipt of parenteral immunoglobulin preparation, blood products and/or plasma
                  derivates within the past 3 months and for the full length of the study;

               -  suspected or known HIV infection or HIV-related disease.

          5. Individuals with known or suspected history of drug or alcohol abuse.

          6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding
             time that in the investigator's opinion could have interfered with the safety of the
             subject.

          7. Individuals who were not able to comprehend and to follow all required study
             procedures for the whole period of the study.

          8. Individuals with history or any illness that, in the opinion of the investigator,
             posed additional risk to the subjects due to participation in the study.

          9. Individuals who within the past 6 months (prior to study enrollement) have:

               -  had any laboratory confirmed seasonal or pandemic influenza disease;

               -  received any seasonal or pandemic influenza vaccine.

         10. Individuals who received any other vaccine within 4 weeks prior to enrollment in this
             study or who were planning to receive any vaccine during the study.

         11. Individuals with any acute or chronic infections required systemic antibiotic
             treatment or antiviral therapy within the last 7 days.

         12. Individuals who had experienced fever (i.e., axillary temperature ≥38°C) within the
             last 3 days of intended study vaccination.

         13. Individuals who participated 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.

         14. Individuals who were part of study personnel or close family members conducting this
             study.

         15. BMI >35 kg/m2.

         16. Females who were pregnant (confirmed by positive urine pregnancy test) or nursing
             (breastfeeding). Females of childbearing potential who refused to use an acceptable
             method of birth control for the whole duration of the study.