A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Inclusion Criteria:

• Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
• Female subjects were to be negative for pregnancy

Exclusion Criteria:

• History of meningococcal disease
• Receipt of any meningococcal vaccine outside of parent study (V59P6)
• Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
• receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
• any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study