Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
Condition: Infections, Meningococcal; Meningococcal Vaccines
MeSH terms: Meningococcal Infections
Intervention: Nimenrix™; Menjugate®; NeisVac-CTM; Infanrix™ hexa; Synflorix™
Intervention description: 4- or 3-dose intramuscular injection; 3-dose intramuscular injection; 3-dose intramuscular injection; 4-dose intramuscular injection; 4-dose intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2095.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infants; conjugate vaccine; immunogenicity; meningococcal vaccine; non-inferiority; co-administration

Summary:

      The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate
      vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2
      months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be
      co-administered.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects who the investigator believes that their parent(s)/Legally Acceptable
             Representative(s) (LAR) can and will comply with the requirements of the protocol
             (e.g. completion of the diary cards, return for follow-up visit).

          -  A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the
             time of the first vaccination.

          -  Written informed consent obtained from the parent(s) or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Born after a gestation period of at least 36 weeks.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Extended administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs since birth. For corticosteroids, this will mean
             prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting 30 days before the first dose of vaccine(s) until 30 days
             after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus
             vaccine which can be administered at any time during the study, according to the
             national immunisation recommendations. MMR(V) vaccine, if recommended in national
             immunisation programs, can be given after the last blood sampling time point i.e.
             after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during
             the study, and according to the Summary of Product Characteristics and national
             recommendations.

          -  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 against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis
             serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be
             given within the first two weeks of life according to the national recommendations
             (for example hepatitis B and BCG).

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures (history of a single, simple febrile
             seizure is permitted).

          -  Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature
             ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on
             rectal setting).

        (Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection)
        without fever may, be enrolled at the discretion of the investigator).

        - Administration of immunoglobulins and/ or any blood products since birth or planned
        administration during the study period.