Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Lot A of Influenza virus vaccine; Lot B of Influenza virus vaccine; Lot C of Influenza virus vaccine; Comparator influenza virus vaccine; All 3 consecutive lots of influenza virus vaccine pooled
Intervention description: 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly; 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1507.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; adults; different lots; trivalent subunit influenza virus vaccine (IVV); trivalent subunit influenza vaccine

Summary:

      The purpose of this research is to demonstrate immunologic equivalence of three consecutive
      production lots of the subunit influenza vaccine compared to egg-derived inactivated
      influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to
      show how safe and well tolerated a conventional inactivated subunit influenza vaccine,
      licensed in many countries outside the United States, is compared to an inactivated influenza
      vaccine, licensed in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 49 years of age;

          -  In good health as determined by medical history and physical examination;

          -  Able and willing to provide written informed consent prior to any study procedure;

          -  Able to comply with all study procedures and available for all clinic visits scheduled
             in the study.

        Exclusion Criteria:

          -  Any serious disease, such as: cancer, autoimmune disease (including rheumatoid
             arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus

          -  History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs,
             egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any
             other vaccine component, chemically related substance, or component of the potential
             packaging materials (latex);

          -  Known or suspected impairment/alteration of immune function

          -  Receipt of an influenza vaccine within 6 months prior to Visit 1;

          -  Current drug or alcohol abuse or a history of drug or alcohol abuse that in the
             investigator's opinion would interfere with safety of the subject or the evaluation of
             the study objectives;

          -  Laboratory-confirmed influenza disease within 6 months prior to Visit 1