Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived); Phosphate buffered saline
Intervention description: Trivalent, non-adjuvanted vaccine; dose: 0.5 ml; Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3670.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to demonstrate the efficacy of an investigational
      Vero-cell derived influenza vaccine to prevent infection in an adult population with an
      influenza virus that is antigenically similar to one of the three strains in the vaccine. All
      subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of
      three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will
      be monitored for 180 days following vaccination for occurrence of adverse events. For
      determining antibody response, subjects will have one blood draw before and one blood draw 21
      days after vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

        Male and female subjects who

          -  are 18 to 49 years of age, inclusive, on the day of screening

          -  have an understanding of the study, agree to its provisions and give written informed
             consent prior to study entry

          -  If female and capable of bearing children - have a negative urine pregnancy test
             result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate
             birth control measures. For the purposes of this study adequate birth control measures
             incorporate two types of the following FDA approved birth control measures through 60
             days after the vaccination: hormonal types of birth control (such as implants, birth
             control pills, patches or other methods) or an intrauterine device, OR an additional
             barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps,
             etc.).

        Exclusion Criteria:

        Subjects who have any of the risk factors for complications from influenza infection as
        defined by the Centers for Disease Control and Prevention (CDC):

          -  pregnancy

          -  chronic disorders of the pulmonary or cardiovascular system including asthma
             (hypertension is not considered a high risk condition)

          -  chronic renal disorders

          -  chronic hepatic disorders

          -  chronic hematological disorders

          -  chronic metabolic disorder (including diabetes mellitus)

          -  immunosuppression (including immunosuppression caused by medications or HIV)

          -  any condition that can compromise respiratory function or the handling of respiratory
             secretions or that can increase risk for aspiration (e.g., cognitive dysfunction,
             spinal cord injuries, seizure disorders or other neuromuscular disorders)

          -  residence in a nursing home or other chronic care facility that houses persons of any
             age who have chronic medical conditions

          -  household contact with children aged 0 to 59 months or of someone who is included in
             the risk categories listed above

          -  employment as a health care worker

        Subjects are also excluded if they

          -  are unable to lead an independent life as a result of either physical or mental
             handicap

          -  have a history of severe allergic reactions or anaphylaxis

          -  have an oral temperature of >= 99.5° F (37.5°C) on the day of vaccination in this
             study. [NOTE: Subjects meeting this exclusion criterion may be rescheduled for
             vaccination and study entry at a later date provided: 1.) oral temperature has
             decreased to < 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/exclusion
             criteria are met, 3.) the rescheduled date is no more than 14 days past the initial
             screening date, 4.) the study site is still enrolling subjects]

          -  have a rash or dermatologic condition or tattoos which may interfere with injection
             site reaction rating

          -  have received a blood transfusion or immunoglobulins within 90 days of study entry

          -  have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of
             study entry

          -  have previously been vaccinated against influenza for the 2007/2008 northern
             hemisphere influenza season

          -  have functional or surgical asplenia

          -  have a known or suspected problem with alcohol or drug abuse

          -  were administered an investigational drug within six weeks prior to study entry or are
             concurrently participating in a clinical study that includes the administration of an
             investigational product

          -  are a member of the team conducting this study or are in a dependent relationship with
             the study investigator. Dependent relationships include close relatives (i.e.,
             children, spouse/partner, siblings, parents) as well as employees of the investigator.