Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Condition: Seasonal Influenza; Vaccine
MeSH terms: Influenza, Human
Intervention: Cell-derived influenza vaccine; Egg-derived influenza vaccine
Intervention description: 1 dose of 0.5 mL in the deltoid region of the non-dominant arm; 1 dose of 0.5 mL in the deltoid region of the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 1398.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; vaccine

Summary:

      Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian
      Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and
      without underlying medical conditions and evaluation of the immunogenicity in a subset of
      subjects with underlying medical conditions, compared to an egg-based vaccine in a post
      marketing setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects 18 years of age and above, mentally competent, willing and able to give
             informed consent prior to study entry;

          2. Able to comply with all study procedures and requirements.

        Exclusion Criteria:

          1. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any
             vaccine component;

          2. Fatal prognosis of an underlying medical condition (<12 months life expectancy);

          3. History of Guillain-Barre syndrome;

          4. Bleeding diathesis or receiving anticoagulants of the coumarin type;

          5. Hospitalization or residence in a nursing care facility;

          6. Planned to receive seasonal influenza vaccine outside of this study;

          7. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for
             live vaccines) prior to enrollment in this study;

          8. Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days
             prior to study vaccination;

          9. 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, whichever
             is longer, and unwilling to refuse participation in another clinical study through the
             end safety follow up period of the study;

         10. Any condition, which, in the opinion of the investigator, might prevent the subject
             from participation or interfere with the evaluation of the study objectives;

         11. Females who were pregnant or nursing (breastfeeding) mothers, or females of
             childbearing potential who were sexually active and had not used or did not plan to
             use acceptable birth control measures during the first 3 weeks after vaccination.
             Oral, injected or implanted hormonal contraceptive, diaphragm or condom with
             spermicidal agent or intrauterine device were considered acceptable forms of birth
             control.