A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

Completed · Phase 3

Conditions studied: Meningococcal Vaccine

In brief

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Key facts

Study ID

NCT01830855

Run by

Pfizer

People needed

3596

Starts

2013-04-01

Expected to finish

2015-04-01

Last updated by the study team

2016-06-14

Who can join

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

You may qualify if…

• Male or female subject aged >=10 and <19 years at the time of enrollment.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.

You may not qualify if…

• Previous vaccination with any meningococcal serogroup B vaccine.
• Subjects who have received prior HAV vaccination.
• Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
• Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Current chronic use of systemic antibiotics.
• Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Southeastern Pediatrics — Dothan, Alabama, United States
• Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Arkansas Pediatric Clinic — Little Rock, Arkansas, United States
• California Research Foundation — San Diego, California, United States
• Colorado Springs Health Partners/Clinical Research Advantage, Inc. — Colorado Springs, Colorado, United States
• Aga Clinical Trials — Hialeah, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Accelovance — Melbourne, Florida, United States
• Accelovance — Melbourne, Florida, United States
• North Georgia Clinical Research Center — Dalton, Georgia, United States
• Northern Illinois Research Associates — DeKalb, Illinois, United States
• Northpoint Pediatrics — Indianapolis, Indiana, United States
• Accelovance, Inc. — Mishawaka, Indiana, United States
• Optimal Research, LLC — Mishawaka, Indiana, United States
• Nassim, McMonigle, Mescia & Associates — New Albany, Indiana, United States
• Augusta Family Practice — Augusta, Kansas, United States
• Heartland Research Associates, LLC — Augusta, Kansas, United States
• Heartland Research Associates, LLC — Newton, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Bluegrass Clinical Research, Inc. — Louisville, Kentucky, United States
• Birmingham Pediatric Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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