A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age



Status:Completed
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 12
Updated:12/22/2018
Start Date:September 28, 2011
End Date:May 8, 2014

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A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years

This is a clinical study to assess the safety, tolerance and immunogenic response to
MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and
W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine.
Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized
into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to
all injections given throughout the study. An unblinded administrator will be responsible to
administer the vaccinations to all subjects and will be unblinded to the subject
randomization in order to determine which subjects were in randomized to group 3 so they may
receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be
conducted with all subjects 6-months post their last vaccination to obtain safety
information.


Inclusion Criteria:

- Evidence of a personally signed and dated informed consent document (ICD) indicating
that the subject (and a legally authorized representative) has been informed of all
pertinent aspects of the study.

- Parent /legally authorized representative and subjects who are willing and able to
comply with scheduled visits, laboratory tests, and other study procedures.

- Male or female subject aged greater than or equal to 10 and <13 years at the time of
enrollment.

- Available for the entire study period and can be reached by telephone.

- Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.

- Has received full series (5-dose series is preferred, 4-dose catch up series is
allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per
country specific recommendations applicable at the time of receipt.

- Male and female subjects of childbearing potential must agree to use a highly
effective method of contraception throughout the study.

Exclusion Criteria:

- Previous vaccination with any meningococcal serogroup B vaccine.

- Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the
first study vaccination.

- Previous vaccination with any MCV4 vaccine.

- A previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with MCV4 and/or Tdap vaccine.

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

- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

- 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 with
terminal complement deficiency may not be included.

- History of culture-proven disease caused by Neisseria meningitidis or Neisseria
gonorrhoea.

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

- Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.

- Current chronic use of systemic antibiotics.

- 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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Wichita, Kansas 67028
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Akron, Ohio 44311
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Anderson, South Carolina 29621
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Atlanta, Georgia
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Augusta, Kansas 67010
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Austin, Texas 78745
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Bardstown, Kentucky 40004
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Birmingham, Alabama 35209
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Bristol, Tennessee 37620
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Burke, Virginia 22015
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Chandler, Arizona 85225
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198 Rutledge Avenue
Charleston, South Carolina 29403
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1011 East Jefferson Street
Charlottesville, Virginia 22902
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Colorado Springs, Colorado 80907
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2960 North Circle Drive
Colorado Springs, Colorado 80909
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Columbus, Ohio 43212
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Cranston, Rhode Island 02920
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Dallas, Texas 75231
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Denver, Colorado 80239
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East Syracuse, New York 13057
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Fargo, North Dakota 58103
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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11234 Anderson St
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Marietta, Georgia 30062
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Meridian, Idaho 83642
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Monroe, Wisconsin 53566
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Mount Pleasant, South Carolina 29464
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Murray, Utah 84123
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Nashville, Tennessee 37203
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Norman, Oklahoma 73069
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Norwich, Connecticut 06360
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Paramount, California 90723
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Raleigh, North Carolina 27609
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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Saint Louis, Missouri 63110
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