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

Status:	Completed
Conditions:	Infectious Disease, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	16 - 23
Updated:	4/21/2016
Start Date:	January 2010
End Date:	July 2010

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

We found this trial at

sites

Clinical Trial Facility in Rochester Minnesota

Rochester, Minnesota 55905

from

Rochester, MN