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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 25
Updated:4/21/2016
Start Date:May 2013
End Date:February 2015

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A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years

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.


Inclusion Criteria:

1. Male or female subject aged >=18 and <26 years at the time of enrollment.

2. Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.

3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.

2. 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.

3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.

4. 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.

5. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).

6. Current chronic use of systemic antibiotics.

7. Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.

8. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
We found this trial at
34
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Bay Roberts, Newfoundland and Labrador
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Bellevue, Nebraska 68005
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Bellevue, Nebraska 68005
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Cleveland, Ohio 44122
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Dakota Dunes, South Dakota 57049
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Dallas, Texas 75010
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East Greenwich, Rhode Island 02818
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Hollyood, Florida 33024
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Kansas City, Missouri 64114
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La Mesa, California 91942
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Lenexa, Kansas 66219
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Manlius, New York 13104
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Metairie, Louisiana 70006
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Milford, Massachusetts 01757
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Mobile, Alabama 36608
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Omaha, Nebraska 68134
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Raleigh, North Carolina 27609
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Sacramento, California 95816
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Upper St. Clair, Pennsylvania 15241
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West Jordan, Utah 84088
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