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
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Jonesboro, Arkansas 72401
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Amarillo, Texas 79106
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Bossier City, Louisiana 71111
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Boston, Massachusetts 02115
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Charleston, South Carolina 29425
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Cleveland, Ohio 44195
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Clyde, North Carolina 28721
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Des Moines, Iowa 50314
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Dothan, Alabama 36305
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Erie, Pennsylvania 16507
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Fall River, Massachusetts 02720
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Fayetteville, Arkansas 72703
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Fountain Valley, California 92708
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Fresno, California 93720
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Galveston, Texas 77555
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Greenville, Pennsylvania 16125
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Gresham, Oregon 97030
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Henderson, Nevada 89052
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Huber Heights, Ohio 45424
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Huntington Beach, California 92647
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Kalamazoo, Michigan 49007
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Kingsport, Tennessee 37660
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Layton, Utah 84041
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