Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal group B Vaccine, rMenB+OMV NZ; Meningococcal ACWY Conjugate Vaccine, MenACWY
Intervention description: 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.; 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 85 Days
Maximum age: 119 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Central Nervous System Diseases; Nervous System Diseases; Meningitis

Summary:

      The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability
      of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at
      3, 5, 7 and 13 months of age, compared to either alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose
             parents/legal guardians have given written informed consent after the nature of the
             study has been explained.

          2. Available for all the visits scheduled in the study.

          3. In good health as determined by medical history, physical examination and clinical
             judgment of the investigator.

        Exclusion Criteria:

          1. History of any previous immunization with a meningococcal vaccine or vaccine
             containing meningococcal antigen(s) at the time of enrollment.

          2. Previous known or suspected disease caused by N. meningitidis.

          3. Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis infection or colonization.

          4. History of severe allergic reaction after previous vaccinations, or hypersensitivity
             to any component of the vaccine.

          5. Known or suspected autoimmune disease or impairment/alteration of the immune system
             resulting from, for ex-ample:

               -  Chronic administration of immunosuppressants or other immune-modifying drugs
                  since birth (3 months prior). (For corticosteroids, this means prednisone, or
                  equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled
                  and topical steroids are allowed),

               -  Immune deficiency disorder, or known HIV infection.

          6. Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation since birth.

          7. History of any progressive or severe neurologic disorder, or seizure disorder or
             Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).

          8. History of any bleeding disorder considered as a contraindication to intramuscular
             injection or blood draw.

          9. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all
             required study procedures for the whole period of the study.

         10. Receipt of any investigational or non-registered product since birth (3 month prior)
             or are expected to receive during the study period.

         11. Family members or household members of site research staff.

         12. Any clinically-significant chronic or progressive disease according to judgment of the
             investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional
             abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).

         13. History or any illness/condition that, in the opinion of the investigator, might
             interfere with the results of the study or pose additional risk to the subjects due to
             participation in the study.