Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

• 40 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 40 months of age ] [ Designated as safety issue: No ]
• 60 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 60 months of age ] [ Designated as safety issue: No ]

The primary objective is to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 study who received Novartis MenACWY Conjugate Vaccine. The study will also enroll age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at the 60 months will be evaluated.

• Biological: Meningococcal ACWY conjugate vaccine
  Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
• Biological: Meningococcal ACWY conjugate vaccine
  Medically attended Adverse Events and SAEs will be collected for 28 days post injection.

• Experimental: Group 1
  Subjects who previously received the Novartis MenACWY vaccine with a 2,4,6,12 or 2,4,6,13 months of age schedule in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
  Intervention: Biological: Meningococcal ACWY conjugate vaccine
• Experimental: Group 2
  Subjects who previously received the Novartis MenACWY vaccine in the second year of life in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
  Intervention: Biological: Meningococcal ACWY conjugate vaccine
• Experimental: Group 3
  Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 40 months of age. Blood draw at 40 months of age and an optional dose of MenACWY.
  Intervention: Biological: Meningococcal ACWY conjugate vaccine
• Experimental: Group 4
  Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 60 months of age. Blood draw at 60 months of age and dose of MenACWY. Blood draw 28 days after the injection.
  Intervention: Biological: Meningococcal ACWY conjugate vaccine

Inclusion Criteria:

• Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
• Group 1 and 2 (Follow on) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
• Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

Exclusion Criteria:

• Serious, acute, or chronic illnesses are reasons for exclusion.
• Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
• Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive) or last study dose in V59P14 trial (Groups 1 & 2 - follow on).