Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:12/27/2018
Start Date:July 5, 2007
End Date:November 26, 2008

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Study to Assess Immunogenicity, Reactogenicity and Safety of Primary Vaccination With GSK Biologicals' MenACWY Vaccine (GSK134612) Given as 1 or 2 Doses to Healthy Toddlers 9-12 Months of Age

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of
GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9
and 12 months of age.

The protocol posting has been amended to reflect changes as a consequence of an amendment to
the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are
Brief Title, Official Title of the study, Brief Summary, Key Inclusion & Exclusion criteria.

Inclusion Criteria:

- Subjects whose parents/guardians the investigator believes can and will comply with
the requirements of the protocol

- A male or female of 9 months of age (has not attained 10 months of age) at the time of
enrollment.

- Up to date on vaccinations based on ACIP recommendations and the standard practice at
the investigational site.

- Written informed consent obtained from parents/guardian of the subject.

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

Exclusion Criteria:

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

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.

- Planned administration of a tetanus toxoid (TT) containing vaccine throughout the
active phase of the study (through one month after the last vaccination).

- Previous vaccination with meningococcal polysaccharide or conjugate vaccine of
serogroup A, C W and/or Y.

- History of meningococcal diseases.

- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
or secondary), including human immunodeficiency virus (HIV) infection, based on
medical history and physical examination (no laboratory testing is required).

- A family history of congenital or hereditary immunodeficiency, until the immune
competence of the potential vaccine recipient is demonstrated.

- History of reactions or allergic disease likely to be exacerbated by any component of
the vaccine.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at the time of enrollment.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the active
phase of the study (through one month after the last dose of study vaccine).
We found this trial at
18
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Erie, Pennsylvania 16507
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Amarillo, Texas 79106
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Antioch, California 94509
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Benton, Arkansas 72019
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Birmingham, Alabama 35249
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Birmingham, Georgia 35244
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Canton, Ohio 44708
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Fremont, California 94538
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Greenville, Pennsylvania 16125
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Hayward, California 94545
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Lakewood, Colorado 80228
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Little Rock, Arkansas 72205
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Littleton, Colorado 80120
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Madera, California 93637
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Santa Rosa, California 95403
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Vacaville, California 95688
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Westminster, Colorado 80234
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Wheat Ridge, Colorado 80033
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