A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Completed · Phase 3 · Has a placebo group

Conditions studied: Healthy

In brief

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Key facts

Study ID

NCT01352845

Run by

Pfizer

People needed

3301

Starts

2013-05-01

Expected to finish

2015-02-01

Last updated by the study team

2016-02-23

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subject aged >=18 and <26 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 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

• Clinical Research Advantage, Inc./Desert Clinical Research, LLC — Mesa, Arizona, United States
• Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC — Tempe, Arizona, United States
• Clinical Research Advantage, Inc./ Fiel Family and Sports Medicine, PC — Tempe, Arizona, United States
• Anaheim Clinical Trials LLC — Anaheim, California, United States
• eStudySite — La Mesa, California, United States
• Benchmark Research — Sacramento, California, United States
• Broward Research Group — Hollyood, Florida, United States
• Altus Research Inc. — Lake Worth, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Johnson County Clin-Trials, Inc. — Lenexa, Kansas, United States
• Benchmark Research — Metairie, Louisiana, United States
• Milford Emergency Associates, Inc. — Milford, Massachusetts, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Bellevue Urgent Care — Bellevue, Nebraska, United States
• Meridian Clinical Research — Bellevue, Nebraska, United States
• Pioneer Clinical Research, LLC — Bellevue, Nebraska, United States
• Meridian Clinical Research, — Omaha, Nebraska, United States
• Central New York Clinical Research — Manlius, New York, United States
• PMG Research of Raleigh, LLC — Raleigh, North Carolina, United States
• Community Research — Cincinnati, Ohio, United States
• Rapid Medical Research, Inc. — Cleveland, Ohio, United States
• Rapid Medical Research — Cleveland, Ohio, United States
• PEAK Research, LLC — Upper Saint Clair, Pennsylvania, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.