A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Completed · Phase 3 · Has a placebo group

Conditions studied: Meningitis, Meningococcal

In brief

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Key facts

Study ID

NCT01352793

Run by

Pfizer

People needed

5715

Starts

2012-11-01

Expected to finish

2014-09-01

Last updated by the study team

2015-03-11

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects aged 10 to 25 years.

You may not qualify if…

• Previous vaccination with Hepatitis A virus vaccine
• Previous vaccination with investigational meningococcal B vaccine
• History of culture-proven N. meningitidis serogroup B disease
• Any neuroinflammatory or autoimmune condition
• Any immune defect that would prevent an effective response to the study vaccine

Where it is running

• Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Clinical Research Advantage, Inc/ East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Cassidy Medical Group/Clinical Research Advantage — Tempe, Arizona, United States
• Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC — Tempe, Arizona, United States
• Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC Administrative/Mailing Address — Tempe, Arizona, United States
• Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
• Accelovance. Inc — San Diego, California, United States
• Benchmark Research — San Francisco, California, United States
• Cassidy Medical Group/Clinical Research Advantage — Vista, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Optimal Research, LLC — Melbourne, Florida, United States
• Accelovance — Melbourne, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Accelovance,Inc. — Mishawaka, Indiana, United States
• Clinical Research Advantage,Inc/Ridge Family Practice — Council Bluffs, Iowa, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Clinical Research Advantage, Inc./ Pediatric Partners, LLC Additional Site-No IP — Fremont, Nebraska, United States
• Prairie Fields Family Medicine/Clinical Research Advantage — Fremont, Nebraska, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Rapid Medical Research. Inc. — Cleveland, Ohio, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• PMG Research of Bristol — Bristol, Tennessee, United States
• Accelovance,Inc. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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