Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents

Completed · Phase 2 · Has a placebo group

Conditions studied: Meningococcal Disease

In brief

Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single dose of MenACWY vaccine.

Key facts

Study ID

NCT02140762

Run by

Novartis Vaccines

People needed

305

Starts

2014-05-01

Expected to finish

2015-02-01

Last updated by the study team

2018-09-12

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment.
• Female subjects of childbearing potential must have a negative urine pregnancy test.

You may not qualify if…

• Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine.
• Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization.

Where it is running

• Accelovance, Inc — Huntsville, Alabama, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Accelovance, Inc — Melbourne, Florida, United States
• Heartland Research Associates LLC — Newton, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Bluegrass Clinical Research, Inc. — Louisville, Kentucky, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Senders Pediatrics — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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