Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. 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.

Inclusion Criteria:

Subjects enrolled in V59P13:

• healthy subjects who have completed the V59P13 study.

Naïve subjects:

• healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).

Exclusion Criteria:

Subjects who had completed the V59P13 study:

• who received any meningococcal vaccine after the V59P13 trial;
• who have had previous confirmed or suspected disease caused by N. meningitidis;
• who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
• subjects with any serious, acute or chronic progressive disease.

Naïve subjects:

• who previously received any meningococcal vaccine;
• who have had previous confirmed or suspected disease caused by N. meningitidis;
• who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
• subjects with any serious, acute or chronic progressive disease.