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

Completed · Phase 2

Conditions studied: Meningococcal Disease, Meningococcal Meningitis

In brief

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.

Key facts

Study ID

NCT01018732

Run by

Novartis Vaccines

People needed

155

Starts

2010-01-01

Expected to finish

2010-07-01

Last updated by the study team

2015-07-15

Who can join

Age: 16 and older, up to 23. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Rochester, Minnesota, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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