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
65
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1306
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Mineola, NY
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900 W 49th St # 430
Hialeah, Florida 33012
1312
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Hialeah, FL
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4085 University Blvd S # 1
Jacksonville, Florida 32216
1060
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Jacksonville, FL
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
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Wichita, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
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Wichita, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
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Wichita, KS
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Asheboro, North Carolina 27203
1005
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Asheboro, NC
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Augusta, Kansas 67010
46
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Augusta, KS
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Augusta, Kansas 67010
46
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Bardstown, Kentucky 40004
674
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Bardstown, KY
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Bellevue, Nebraska 68005
256
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Bellevue, NE
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Bellevue, Nebraska 68005
255
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Bellevue, NE
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Birmingham, Alabama 35235
688
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Birmingham, AL
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Birmingham, Alabama 35205
684
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Birmingham, AL
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Cary, North Carolina 27518
1061
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Cary, NC
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Charlottesville, Virginia 22902
1053
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Charlottesville, VA
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Charlottesville, Virginia 22902
1053
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894
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Cleveland, OH
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386
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Colorado Springs, CO
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744
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Dalton, GA
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Dayton, Ohio 45406
744
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Dayton, OH
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746
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Dayton, OH
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Dayton, Ohio 45414
745
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DeKalb, Illinois 60115
560
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DeKalb, IL
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Dothan, Alabama 36305
838
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Dothan, AL
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Erie, Pennsylvania 16508
983
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Erie, PA
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Eunice, Louisiana 70535
588
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Eunice, LA
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588
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Eunice, LA
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Harrisburg, Arkansas 72432
421
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Harrisburg, AR
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Haughton, Louisiana 71037
435
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Haughton, LA
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Hendersonville, Tennessee 37075
625
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Hendersonville, TN
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Indianapolis, Indiana 46256
652
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Indianapolis, IN
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Jonesboro, Arkansas 72401
416
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Jonesboro, AR
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Kingsport, Tennessee 37660
843
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Kingsport, TN
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Kingsport, Tennessee 37660
843
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Lebanon, Tennessee 37087
738
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Lebanon, TN
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Little Rock, Arkansas 72205
369
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Little Rock, AR
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Louisville, Kentucky 40291
667
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Louisville, KY
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Melbourne, Florida 32935
1193
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Melbourne, FL
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Metairie, Louisiana 70006
690
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Metairie, LA
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1305
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Mineola, NY
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Mineola, New York 11501
1305
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Mineola, NY
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Mineola, New York 11501
1305
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Mishawaka, Indiana 46545
675
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Mishawaka, IN
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Mishawaka, Indiana 46545
676
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Mishawaka, IN
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Mountain Sterling, Kentucky 40353
755
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Mountain Sterling, KY
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MT. Sterling, Kentucky 40353
756
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MT. Sterling, KY
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New Albany, Indiana 47150
653
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New Albany, IN
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Newton, Kansas 67114
33
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Newton, KS
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674
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Niles, MI
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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...
262
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Omaha, NE
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Omaha, Nebraska 68134
262
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Owensboro, Kentucky 42301
581
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Pittsburgh, Pennsylvania 15226
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Raleigh, North Carolina 27609
1067
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1068
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Rochester, New York 14609
1122
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Rochester, NY
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Saint Louis, Missouri 63141
403
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Saint Louis, MO
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Saint Paul, Minnesota 55108
553
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San Diego, California 92103
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Stevensville, Michigan 49127
666
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Uniontown, Pennsylvania 15401
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Upper St. Clair, Pennsylvania 15241
967
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Vancouver, Washington 98664
1381
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Vienna, Virginia 22180
1115
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