Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Boostrix®
Intervention description: One dose administered intramuscularly (IM) in the deltoid muscle of the arm.; One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 692.0
Sex: All
Minimum age: 11 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Young adults; Adolescents; Reactogenicity; Diphtheria; pertussis; Immunogenicity; Tetanus; Meningococcal vaccines; Safety; Neisseria meningitidis; Healthy

Summary:

      The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the
      meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of
      the two vaccines given separately in healthy adolescents and young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  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 male or female between, and including, 11 and 25 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
             subject.

          -  Written informed assent obtained from the subjects when applicable according to local
             regulations.

          -  Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,
                  hysterectomy or ovariectomy.

          -  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 two months after completion of the vaccination series.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             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 mean
             prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose of vaccine and ending 30 days
             after the last dose of vaccine, 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 or a
             non-investigational product.

          -  Previous vaccination with a meningococcal vaccine.

          -  History of meningococcal disease.

          -  Vaccination with a DTP-containing vaccine within the previous five years.

          -  History of serious allergic reaction following any other DTP-containing vaccine or any
             component of the study vaccines.

          -  History of encephalopathy within seven days following administration of a previous
             dose of pertussis vaccine that is not attributable to another identifiable cause.

          -  Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP
             vaccine, 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.

          -  Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid
             (TT) within the previous ten years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination during the study period.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.

          -  History of any neurologic disorders or seizures, including Guillain-Barré syndrome
             (GBS). History of a simple, single febrile seizure is permitted.

          -  Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on
             anticoagulant therapy.

          -  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.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic
                  route.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.