This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine



Status:Active, not recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:10/14/2018
Start Date:September 14, 2017
End Date:March 8, 2019

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Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age

The purpose of this study is to assess if there is any immune interference between the
Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant
vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as
compared to the currently licensed lyophilized formulation of the HRV vaccine when
co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age


Inclusion Criteria:

- Subjects' parent(s)/[LAR(s)] who, in the opinion of the investigator can and will
comply with the requirements of the protocol.

- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the
time of the first study vaccination.

- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s)
of the subject prior to performing any study specific procedure.

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

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product other than the study vaccines
during the period starting 30 days before the first dose of study vaccines (Day-29 to
Day 1), or planned use during the study period.

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs since birth. For corticosteroids, this will mean
prednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.

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

- Administration of long-acting immune-modifying drugs at any time during the study
period.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within the period starting 30 days before the first dose of vaccine administration and
ending at Visit 4, with the exception of the inactivated influenza vaccine, which is
allowed at any time during the study, if administered at a site which is different
from the sites used to administer the co-administered vaccines.

- Concurrently participating 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 vaccine/product.

- Uncorrected congenital malformation of the gastrointestinal tract that would
predispose for Intussusception (IS).

- History of IS.

- Very prematurely born infants (born ≤28 weeks of gestation).

- Family history of congenital or hereditary immunodeficiency.

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

- Major congenital defects or serious chronic illness.

- Previous vaccination against Haemophilus type b (Hib), diphtheria, tetanus, pertussis,
pneumococcus, RV and/or poliovirus.

- Previous confirmed occurrence of RV GE, Hib, diphtheria, tetanus, pertussis,
pneumococcus, hepatitis B and/or polio disease.

- Any medical condition that in the judgment of the investigator would make
intramuscular injection unsafe.

- GE within 7 days preceding the study vaccine administration.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.

- Hypersensitivity to latex.

- History of any neurological disorders or seizures.

- History of Severe combined immunodeficiency (SCID).

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for
measuring temperature in this study will be the oral cavity, the axilla and the
rectum.

- Subjects with a minor illness without fever may be enrolled at the discretion of
the investigator.
We found this trial at
45
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Dayton, Ohio 45420
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Altamonte Springs, Florida 32714
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Bardstown, Kentucky 40004
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Bingham Farms, Michigan 48025
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Birmingham, Alabama 35249
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Boone, North Carolina 28607
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Boynton Beach, Florida 33472
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Bronx, New York 10461
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Charleston, South Carolina 29425
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Charlottesville, Virginia 22903
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Cleveland, Ohio 44195
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Colorado Springs, Colorado 80910
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Daly City, California 94015
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Fall River, Massachusetts 02720
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Fayetteville, Arkansas 72703
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Fort Worth, Texas 76104
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Frederick, Maryland 21702
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Galveston, Texas 77555
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Grove City, Ohio 43123
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Hermitage, Pennsylvania 16148
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Jonesboro, Arkansas 72401
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Kaysville, Utah 84037
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Kingsport, Tennessee 37660
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Layton, Utah 84041
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Lincoln, Nebraska 68510
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Louisville, Kentucky 40202
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Marshfield, Wisconsin 54449
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Miami, Florida 33136
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Murray, Utah 84107
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Nampa, Idaho 83686
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North Charleston, South Carolina 29456
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Norwich, Connecticut 06360
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Oakland, California 94611
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Orem, Utah 84058
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Provo, Utah 84604
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Raleigh, North Carolina 27614
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Roy, Utah 84067
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South Jordan, Utah 84095
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Syracuse, New York 13210
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Syracuse, Utah 84075
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Tampa, Florida 33612
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Tomball, Texas 77375
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Walnut Creek, California 94596
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West Covina, California 91790
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West Jordan, Utah 84088
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