Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK 134612; SynflorixTM; Infanrix-IPV/HiberixTM
Intervention description: Intramuscular injection; Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 753.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal conjugate vaccine; serogroups A,C, W-135 or Y; meningococcal diseases; Immunogenicity; Neisseria meningitidis; co-administration; routine vaccines

Summary:

      This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK
      134612 in healthy infants, when co-administered with other infant vaccines, on three
      different dose schedules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

          -  A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects 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 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 of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             during the period 30 days before and after each study vaccine administration, with the
             exception of rotavirus vaccine and seasonal or pandemic 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 against diphtheria , tetanus, pertussis, polio (with the
             exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus
             pneumonia.

          -  History of receipt of meningococcal vaccine.

          -  Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the
             administration of the first study vaccine.

          -  History of or intercurrent diphtheria, tetanus, pertussis, polio, 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 th