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



Status:Completed
Conditions:Vaccines, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 18
Updated:7/11/2015
Start Date:April 2013
End Date:April 2015
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

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.


Inclusion Criteria:

1. Male or female subject aged >=10 and <19 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 have received prior HAV vaccination.

3. 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.

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

5. 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.

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

7. Current chronic use of systemic antibiotics.

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

9. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
We found this trial at
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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900 W 49th St # 430
Hialeah, Florida 33012
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Asheboro, North Carolina 27203
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Augusta, Kansas 67010
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Augusta, Kansas 67010
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Bardstown, Kentucky 40004
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Bellevue, Nebraska 68005
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Bellevue, Nebraska 68005
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Birmingham, Alabama 35235
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Birmingham, Alabama 35205
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Cary, North Carolina 27518
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Charlottesville, Virginia 22902
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Charlottesville, Virginia 22902
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Dayton, Ohio 45406
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Dayton, Ohio 45414
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DeKalb, Illinois 60115
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Dothan, Alabama 36305
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Erie, Pennsylvania 16508
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Eunice, Louisiana 70535
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Harrisburg, Arkansas 72432
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Haughton, Louisiana 71037
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Hendersonville, Tennessee 37075
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Indianapolis, Indiana 46256
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Jonesboro, Arkansas 72401
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Kingsport, Tennessee 37660
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Kingsport, Tennessee 37660
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Lebanon, Tennessee 37087
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Little Rock, Arkansas 72205
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Louisville, Kentucky 40291
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Melbourne, Florida 32935
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Metairie, Louisiana 70006
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Mineola, New York 11501
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Mineola, New York 11501
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Mishawaka, Indiana 46545
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Mishawaka, Indiana 46545
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Mountain Sterling, Kentucky 40353
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MT. Sterling, Kentucky 40353
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New Albany, Indiana 47150
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Newton, Kansas 67114
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601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Omaha, Nebraska 68134
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Owensboro, Kentucky 42301
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Pittsburgh, Pennsylvania 15226
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Raleigh, North Carolina 27609
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Rochester, New York 14609
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Saint Louis, Missouri 63141
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Saint Paul, Minnesota 55108
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San Diego, California 92103
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Stevensville, Michigan 49127
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Uniontown, Pennsylvania 15401
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Upper St. Clair, Pennsylvania 15241
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Vancouver, Washington 98664
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Vienna, Virginia 22180
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