Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

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.

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.