Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:9/23/2018
Start Date:February 13, 2008
End Date:September 17, 2009

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Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.

The purpose of the study is to characterize the immunogenicity & safety of a booster dose of
GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months
of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's
Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and
open-label for the booster phase.

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and
W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given
to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In
addition, this study will provide immunogenicity and safety data on the co-administration of
Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out
of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

Inclusion Criteria:

- Subjects for whom the investigator believes that parents/guardians can and will comply
with the requirements of the protocol.

- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time
of the first vaccination.

- Written informed consent obtained from the parent or guardian of the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born after 36 weeks gestation.

- For inclusion in the booster phase, subjects must have received all three doses in the
primary phase.

Exclusion Criteria:

Exclusion criteria for enrolment (primary phase)

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
within 30 days of the first dose of study vaccine(s).

- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,
diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of
hepatitis B vaccine.

- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b,
diphtheria, tetanus, polio or pertussis diseases.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, or by dry natural latex rubber.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at time of enrollment.

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.

- Concurrent participation in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).

Exclusion criteria for enrolment (booster phase)

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or
planned use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days of entry into the booster phase (Visit 4) with the exception of
Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine
is allowed throughout the study)

- Planned administration/administration of a fourth dose of Prevnar® within 30 days of a
booster dose of Infanrix®

- Previous administration of a booster dose of Hib prior to entry to the booster phase.

- Previous administration of a primary dose of Hib vaccine that is not part of the study
protocol.

- Previous vaccination against Neisseria meningitidis that is not part of the study
protocol.

- Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the
primary phase of the study.

- History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, or by dry natural latex rubber.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at time of enrollment.

- Administration of immunoglobulins and/or any blood products within the past 3 months
or planned administration during the study period.

- Concurrent participation in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).
We found this trial at
53
sites
Ogden, Utah 84403
1514
mi
from 43215
Ogden, UT
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Amarillo, Texas 79106
1081
mi
from 43215
Amarillo, TX
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Arkansas City, Kansas 67005
782
mi
from 43215
Arkansas City, KS
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Bardstown, Kentucky 40004
198
mi
from 43215
Bardstown, KY
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Benton, Arkansas 72019
644
mi
from 43215
Benton, AR
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Birmingham, Alabama 35249
493
mi
from 43215
Birmingham, AL
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Bossier City, Louisiana 71111
786
mi
from 43215
Bossier City, LA
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Boston, Massachusetts 02115
643
mi
from 43215
Boston, MA
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Charleston, South Carolina 29425
524
mi
from 43215
Charleston, SC
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Clyde, North Carolina 28721
306
mi
from 43215
Clyde, NC
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Des Moines, Iowa 50314
565
mi
from 43215
Des Moines, IA
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Dothan, Alabama 36305
620
mi
from 43215
Dothan, AL
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Erie, Pennsylvania 16507
214
mi
from 43215
Erie, PA
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Fall River, Massachusetts 02720
633
mi
from 43215
Fall River, MA
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Fayetteville, Arkansas 72703
659
mi
from 43215
Fayetteville, AR
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Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
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Fresno, California 93720
1986
mi
from 43215
Fresno, CA
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Galveston, Texas 77555
992
mi
from 43215
Galveston, TX
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Greenville, Pennsylvania 16125
190
mi
from 43215
Greenville, PA
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Gresham, Oregon 97030
2014
mi
from 43215
Gresham, OR
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Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
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Huber Heights, Ohio 45424
58
mi
from 43215
Huber Heights, OH
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Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
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Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
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Kalamazoo, Michigan 49007
209
mi
from 43215
Kalamazoo, MI
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Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
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Layton, Utah 84041
1515
mi
from 43215
Layton, UT
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Lexington, Kentucky 40504
156
mi
from 43215
Lexington, KY
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Little Rock, Arkansas 72205
625
mi
from 43215
Little Rock, AR
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Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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Marshfield, Wisconsin 54449
488
mi
from 43215
Marshfield, WI
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Nampa, Idaho 83686
1734
mi
from 43215
Nampa, ID
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Niles, Michigan 49120
212
mi
from 43215
Niles, MI
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Orem, Utah 84058
1508
mi
from 43215
Orem, UT
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Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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Plantation, Florida 33324
970
mi
from 43215
Plantation, FL
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Portage, Michigan 49024
203
mi
from 43215
Portage, MI
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Provo, Utah 84604
1506
mi
from 43215
Provo, UT
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Raleigh, North Carolina 27614
366
mi
from 43215
Raleigh, NC
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Richland, Michigan 49083
209
mi
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Richland, MI
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Roy, Utah 84067
1517
mi
from 43215
Roy, UT
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Saint George, Utah 84770
1655
mi
from 43215
Saint George, UT
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Saint Paul, Minnesota 55101
617
mi
from 43215
Saint Paul, MN
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South Jordan, Utah 84095
1517
mi
from 43215
South Jordan, UT
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Stevensville, Michigan 49127
230
mi
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Stevensville, MI
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Sugar Land, Texas 77479
1009
mi
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Sugar Land, TX
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Syracuse, Utah 84075
1520
mi
from 43215
Syracuse, UT
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Uniontown, Pennsylvania 15401
175
mi
from 43215
Uniontown, PA
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West Covina, California 91790
1955
mi
from 43215
West Covina, CA
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West Des Moines, Iowa 50265
570
mi
from 43215
West Des Moines, IA
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West Palm Beach, Florida 33409
930
mi
from 43215
West Palm Beach, FL
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Woodstock, Georgia 30189
413
mi
from 43215
Woodstock, GA
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