Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Pneumococcal vaccine GSK1024850A
Intervention description: Single dose intramuscular injection.; Single dose intramuscular injection.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 363.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Routine infancy vaccination; Meningococcal vaccine; Immunogenicity; Pneumococcal vaccine

Summary:

      The purpose of this study is to demonstrate, in 12-23 months old subjects, the
      non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when
      co-administered, compared to each vaccine administered individually.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between, and including, 12 and 23 months of age at the time of the
             first booster vaccination, who previously participated in study 109661 conducted in
             Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the
             GSK1024850A vaccine.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine(s), 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 first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days before the first dose of vaccine(s) and 30 days after the last dose of
             vaccine(s).

          -  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 (pharmaceutical product or device).

          -  Previous vaccination with a meningococcal vaccine.

          -  Previous administration of a fourth dose of a pneumococcal vaccine

          -  Previous vaccination with tetanus toxoid within the last month (including also tetanus
             toxoid given as part of Hib-TT conjugate vaccine).

          -  History of meningococcal or pneumococcal invasive disease.

          -  History of reactions or allergic disease likely to be exacerbated by any component of
             the vaccines.

          -  Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.

          -  History of seizures (this criterion does not apply to subjects who have had a single,
             uncomplicated febrile convulsion in the past) or progressive neurological disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection, based on medical history and physical
             examination (no laboratory testing required).

          -  A family history of congenital or hereditary immunodeficiency, unless the child has
             previously been documented, through laboratory testing, to have normal immune
             function.

          -  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.