Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Mencevax™ACWY; Fluarix™
Intervention description: One intramuscular dose; One subcutaneous dose; One intramuscular dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1352.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: immunogenicity; Meningococcal serogroups A, C, W-135 and/or Y disease; co-administration; meningococcal vaccine; lot-to-lot consistency; conjugate vaccine

Summary:

      The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of
      different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of
      GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of
      GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612
      given alone and the immunogenicity of GSK134612 given with Fluarix™.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

        For all subjects:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A male or female between, and including, 18 and 55 years of age at the time of the
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Previously completed routine childhood vaccinations to the best of his/her knowledge.

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test, and continue such precautions for 2
             months after completion of the vaccination series.

        Exclusion Criteria:

        For all subjects:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within one month of the dose of vaccine(s).

          -  Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W,
             and/or Y within the last five previous years.

          -  Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup
             A, C, W, and/or Y.

          -  Previous vaccination with tetanus toxoid within the last month.

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including human immunodeficiency virus (HIV) infection, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Pregnant or lactating female.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

        Additional criteria for subjects receiving Fluarix™ co-administration:

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  History of reactions or allergy likely to be exacerbated by any component of the
             vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate,
             or sodium deoxycholate.

          -  History of administration of an influenza vaccine outside of this study, during
             current flu season.