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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Hendersonville, Tennessee 37075
1972
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Hendersonville, TN
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900 W 49th St # 430
Hialeah, Florida 33012
2722
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Hialeah, FL
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4085 University Blvd S # 1
Jacksonville, Florida 32216
2456
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Jacksonville, FL
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1440
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from 98109
Wichita, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1440
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from 98109
Wichita, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1440
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Wichita, KS
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Asheboro, North Carolina 27203
2310
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Asheboro, NC
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Augusta, Kansas 67010
1451
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Augusta, KS
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Augusta, Kansas 67010
1451
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Augusta, KS
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Bardstown, Kentucky 40004
1969
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Bardstown, KY
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Bellevue, Nebraska 68005
1371
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Bellevue, NE
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Bellevue, Nebraska 68005
1372
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Bellevue, NE
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Birmingham, Alabama 35235
2082
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Birmingham, AL
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Birmingham, Alabama 35205
2080
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Birmingham, AL
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Cary, North Carolina 27518
2357
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Cary, NC
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Charlottesville, Virginia 22902
2285
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Charlottesville, VA
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Charlottesville, Virginia 22902
2285
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Charlottesville, VA
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2020
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Cleveland, OH
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1067
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Colorado Springs, CO
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2110
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Dalton, GA
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Dayton, Ohio 45406
1956
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Dayton, OH
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1959
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from 98109
Dayton, OH
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Dayton, Ohio 45414
1955
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Dayton, OH
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DeKalb, Illinois 60115
1679
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DeKalb, IL
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Dothan, Alabama 36305
2244
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Dothan, AL
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Erie, Pennsylvania 16508
2077
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Erie, PA
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Eunice, Louisiana 70535
1974
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Eunice, LA
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1974
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Eunice, LA
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Harrisburg, Arkansas 72432
1817
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Harrisburg, AR
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Haughton, Louisiana 71037
1830
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Haughton, LA
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Indianapolis, Indiana 46256
1870
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Indianapolis, IN
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Jonesboro, Arkansas 72401
1806
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Jonesboro, AR
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Kingsport, Tennessee 37660
2151
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Kingsport, TN
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Kingsport, Tennessee 37660
2150
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Kingsport, TN
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Lebanon, Tennessee 37087
2099
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Lebanon, TN
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Little Rock, Arkansas 72205
1779
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Little Rock, AR
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Louisville, Kentucky 40291
1952
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Louisville, KY
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Melbourne, Florida 32935
2598
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Melbourne, FL
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Metairie, Louisiana 70006
2091
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Metairie, LA
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2417
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Mineola, NY
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Mineola, New York 11501
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Mineola, NY
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Mineola, New York 11501
2417
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Mineola, NY
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2417
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Mineola, NY
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Mishawaka, Indiana 46545
1808
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Mishawaka, IN
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Mishawaka, Indiana 46545
1808
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Mishawaka, IN
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Mountain Sterling, Kentucky 40353
2030
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Mountain Sterling, KY
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MT. Sterling, Kentucky 40353
2030
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MT. Sterling, KY
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New Albany, Indiana 47150
1934
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New Albany, IN
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Newton, Kansas 67114
1420
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Newton, KS
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1798
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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...
1365
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Omaha, NE
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Omaha, Nebraska 68134
1360
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Omaha, NE
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Owensboro, Kentucky 42301
1892
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Owensboro, KY
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Pittsburgh, Pennsylvania 15226
2132
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Pittsburgh, PA
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Raleigh, North Carolina 27609
2359
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Raleigh, NC
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2362
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Raleigh, NC
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Rochester, New York 14609
2160
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Rochester, NY
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Saint Louis, Missouri 63141
1706
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Saint Louis, MO
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Saint Paul, Minnesota 55108
1400
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Saint Paul, MN
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San Diego, California 92103
1063
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San Diego, CA
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Stevensville, Michigan 49127
1781
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Stevensville, MI
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Uniontown, Pennsylvania 15401
2163
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Uniontown, PA
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Upper St. Clair, Pennsylvania 15241
2132
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Upper St. Clair, PA
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Vancouver, Washington 98664
139
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Vancouver, WA
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Vienna, Virginia 22180
2312
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Vienna, VA
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