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

Use our guide to learn which trials are right for you!

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
sites
4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
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...
?
mi
from
South Miami, FL
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
?
mi
from
Warwick, RI
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
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...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Bay Roberts, Newfoundland and Labrador
?
mi
from
Bay Roberts,
Click here to add this to my saved trials
Bellevue, Nebraska 68005
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellevue, Nebraska 68005
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellevue, Nebraska 68005
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75010
?
mi
from
Dallas, TX
Click here to add this to my saved trials
East Greenwich, Rhode Island 02818
?
mi
from
East Greenwich, RI
Click here to add this to my saved trials
Hollyood, Florida 33024
?
mi
from
Hollyood, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City, Missouri 64114
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Katy, TX
Click here to add this to my saved trials
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lenexa, Kansas 66219
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
Manlius, New York 13104
?
mi
from
Manlius, NY
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Milford, Massachusetts 01757
?
mi
from
Milford, MA
Click here to add this to my saved trials
Mobile, Alabama 36608
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Mt. Pleasant, South Carolina
?
mi
from
Mt. Pleasant, SC
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Omaha, Nebraska 68134
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Raleigh, North Carolina 27609
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Sacramento, California 95816
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Upper St. Clair, Pennsylvania 15241
?
mi
from
Upper St. Clair, PA
Click here to add this to my saved trials
West Jordan, Utah 84088
?
mi
from
West Jordan, UT
Click here to add this to my saved trials