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

Status:	Completed
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	11/18/2012
Start Date:	February 2009
End Date:	November 2012
Contact:	Novartis Drug Information Services
Phone:	+1 800 244 7668

An Open-Label, Multi-Center Study to Evaluate the Persistence Of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercial 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 commercial 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, who have completed the V59P13 study and are in good health.

Naïve subjects:

- healthy children aged-matched with subjects enrolled in V59P13 trial.

- aged matched with subjects enrolled in V59P13 (currently 16-23 years old).

Exclusion Criteria:

Subjects enrolled in V59P13:

- who received any meningococcal vaccine after V59P13 trial;

- who have had a 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 a 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.

We found this trial at

sites

Sites 37, 50, Birmingham Pediatric Associates, 806 Saint Vincent's Drive, Suite 615

Birmingham, Alabama 35205

from

Birmingham, AL