Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Cervarix®; Boostrix®
Intervention description: One dose administered intramuscularly (IM) in the deltoid of the right arm.; Three doses administered intramuscularly (IM) in the deltoid of the left arm.; One dose administered intramuscularly (IM) in the deltoid of the left arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1300.0
Sex: Female
Minimum age: 9 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pertussis; Meningococcal meningitis; Meningococcal infections; HPV; Neisseria meningitidis; Vaccines, conjugate; tetanus; diphtheria; Meningococcal vaccines; Immunogenicity

Summary:

      The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals'
      meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to
      MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with
      Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix
      co-administered with Boostrix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in
             the opinion of the investigator, can and will comply, with the requirements of the
             protocol.

          -  A female between, and including, 9 and 25 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from parents/guardian of the subject and written
             informed assent obtained from the subject if the subject is less than legal age, or
             written informed consent obtained from the subject if the subject has achieved legal
             age. The legal age will be determined according to local regulations in each
             participating country.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  hysterectomy, ovariectomy or post-menopause.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period
                  and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose. For corticosteroids, this will be ≥10
             mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting 30 days before and ending 30 days after each study dose of
             vaccine(s), with the exception of licensed inactivated influenza vaccine.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational product
             or a non-investigational vaccine/product.

          -  Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within
             the last 10 years.

          -  History of meningococcal disease since birth.

          -  History of serious allergic reaction following any other DTP-containing vaccine or any
             component of the study vaccines.

          -  History of encephalopathy within seven days of administration of a previous pertussis
             antigen-containing vaccine that is not attributable to another identifiable cause.

          -  Persons who experienced an Arthus-type hypersensitivity reaction following a prior
             dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least
             10 years have elapsed since the last dose of tetanus-toxoid containing vaccine.

          -  Previous vaccination with a tetanus-toxoid containing vaccine within the previous five
             years.

          -  Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP
             vaccine (diphtheria-tetanus-whole cell pertussis [DTPw] and/or
             diphtheria-tetanus-acellular pertussis [DTaP]), not due to another identifiable cause.

          -  Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP
             vaccine.

          -  Seizures with or without fever within three days of a previous dose of DTP vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, based on medical history and history
             directed physical examination.

          -  A family history of congenital or hereditary immunodeficiency, until the immune
             competence of the potential vaccine recipient is demonstrated.

          -  History of any allergic disease/reaction or hypersensitivity likely to be exacerbated
             by any component of the vaccine(s).

          -  Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy
             or progressive encephalopathy.

          -  History of any neurologic disorders or seizures. A history of ADHD or depression or a
             history of a single, simple febrile seizure does not exclude a subject.

          -  Major congenital defects or serious chronic illness.

          -  Previous history of Guillain-Barré Syndrome.

          -  Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on
             anti-coagulant therapy.

          -  Acute disease and/or fever 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.

          -  Previous vaccination against HPV, or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period.

          -  Previous administration of MPL or AS04 adjuvant.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Pregnant or lactating female.

          -  A subject planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the study period and up to two months
             after the last vaccine dose.

          -  Subjects must be at least three months post-pregnancy and not breastfeeding to enter
             the study.