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

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

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
sites
Mountain Sterling, Kentucky 40353
?
mi
from
Mountain Sterling, KY
Click here to add this to my saved trials
900 W 49th St # 430
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Asheboro, North Carolina 27203
?
mi
from
Asheboro, NC
Click here to add this to my saved trials
Augusta, Kansas 67010
?
mi
from
Augusta, KS
Click here to add this to my saved trials
Augusta, Kansas 67010
?
mi
from
Augusta, KS
Click here to add this to my saved trials
Bardstown, Kentucky 40004
?
mi
from
Bardstown, KY
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
Birmingham, Alabama 35235
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22902
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Charlottesville, Virginia 22902
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Dalton, GA
Click here to add this to my saved trials
Dayton, Ohio 45406
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45414
?
mi
from
Dayton, OH
Click here to add this to my saved trials
DeKalb, Illinois 60115
?
mi
from
DeKalb, IL
Click here to add this to my saved trials
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Erie, Pennsylvania 16508
?
mi
from
Erie, PA
Click here to add this to my saved trials
Eunice, Louisiana 70535
?
mi
from
Eunice, LA
Click here to add this to my saved trials
?
mi
from
Eunice, LA
Click here to add this to my saved trials
Harrisburg, Arkansas 72432
?
mi
from
Harrisburg, AR
Click here to add this to my saved trials
Haughton, Louisiana 71037
?
mi
from
Haughton, LA
Click here to add this to my saved trials
Hendersonville, Tennessee 37075
?
mi
from
Hendersonville, TN
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Lebanon, Tennessee 37087
?
mi
from
Lebanon, TN
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Louisville, Kentucky 40291
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Melbourne, Florida 32935
?
mi
from
Melbourne, FL
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
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mishawaka, Indiana 46545
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
Mishawaka, Indiana 46545
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
MT. Sterling, Kentucky 40353
?
mi
from
MT. Sterling, KY
Click here to add this to my saved trials
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials
Newton, Kansas 67114
?
mi
from
Newton, KS
Click here to add this to my saved trials
?
mi
from
Niles, MI
Click here to add this to my saved trials
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...
?
mi
from
Omaha, NE
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
Owensboro, Kentucky 42301
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15226
?
mi
from
Pittsburgh, PA
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
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14609
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55108
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Stevensville, Michigan 49127
?
mi
from
Stevensville, MI
Click here to add this to my saved trials
Uniontown, Pennsylvania 15401
?
mi
from
Uniontown, PA
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
Vancouver, Washington 98664
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
Vienna, Virginia 22180
?
mi
from
Vienna, VA
Click here to add this to my saved trials