Phase
Condition
Gastroenteritis
Treatment
N/AClinical Study ID
Ages 6-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects' parent(s)/[LAR(s)] who, in the opinion of the investigator can and willcomply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at thetime 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 beforeentering into the study.
Exclusion
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccinesduring the period starting 30 days before the first dose of study vaccines (Day-29 toDay 1), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressantsor other immune-modifying drugs since birth. For corticosteroids, this will meanprednisone (≥0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products since birth or plannedadministration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the studyperiod.
- Planned administration/administration of a vaccine not foreseen by the study protocolwithin the period starting 30 days before the first dose of vaccine administration andending at Visit 4, with the exception of the inactivated influenza vaccine, which isallowed at any time during the study, if administered at a site which is differentfrom the sites used to administer the co-administered vaccines.
- Concurrently participating in another clinical study, at any time during the studyperiod, in which the subject has been or will be exposed to an investigational or anon-investigational vaccine/product.
- Uncorrected congenital malformation of the gastrointestinal tract that wouldpredispose 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 onmedical 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 makeintramuscular injection unsafe.
- GE within 7 days preceding the study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any componentof 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 formeasuring temperature in this study will be the oral cavity, the axilla and therectum.
- Subjects with a minor illness without fever may be enrolled at the discretion ofthe investigator.
Study Design
Connect with a study center
GSK Investigational Site
Birmingham, Alabama 35205
United StatesSite Not Available
GSK Investigational Site
Fayetteville, Arkansas 72703
United StatesSite Not Available
GSK Investigational Site
Jonesboro, Arkansas 72401
United StatesSite Not Available
GSK Investigational Site
Daly City, California 94015
United StatesSite Not Available
GSK Investigational Site
Oakland, California 94611
United StatesSite Not Available
GSK Investigational Site
Walnut Creek, California 94596
United StatesSite Not Available
GSK Investigational Site
West Covina, California 91790
United StatesSite Not Available
GSK Investigational Site
Colorado Springs, Colorado 80922
United StatesSite Not Available
GSK Investigational Site
Norwich, Connecticut 06360
United StatesSite Not Available
GSK Investigational Site
Altamonte Springs, Florida 32701
United StatesSite Not Available
GSK Investigational Site
Boynton Beach, Florida 33435
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33142
United StatesSite Not Available
GSK Investigational Site
Tampa, Florida 33617
United StatesSite Not Available
GSK Investigational Site
Nampa, Idaho 83686
United StatesSite Not Available
GSK Investigational Site
Bardstown, Kentucky 40004
United StatesSite Not Available
GSK Investigational Site
Louisville, Kentucky 40202
United StatesSite Not Available
GSK Investigational Site
Frederick, Maryland 21702
United StatesSite Not Available
GSK Investigational Site
Fall River, Massachusetts 02721
United StatesSite Not Available
GSK Investigational Site
Bingham Farms, Michigan 48025
United StatesSite Not Available
GSK Investigational Site
Lincoln, Nebraska 68504
United StatesSite Not Available
GSK Investigational Site
Bronx, New York 10468
United StatesSite Not Available
GSK Investigational Site
Syracuse, New York 13202
United StatesSite Not Available
GSK Investigational Site
Boone, North Carolina 28607
United StatesSite Not Available
GSK Investigational Site
Raleigh, North Carolina 27609
United StatesSite Not Available
GSK Investigational Site
Cleveland, Ohio 44121
United StatesSite Not Available
GSK Investigational Site
Dayton, Ohio 45406
United StatesSite Not Available
GSK Investigational Site
Grove City, Ohio 43123
United StatesSite Not Available
GSK Investigational Site
Hermitage, Pennsylvania 16148
United StatesSite Not Available
GSK Investigational Site
Charleston, South Carolina 29407
United StatesSite Not Available
GSK Investigational Site
North Charleston, South Carolina 29406-9170
United StatesSite Not Available
GSK Investigational Site
Kingsport, Tennessee 37660
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76107
United StatesSite Not Available
GSK Investigational Site
Galveston, Texas 77555
United StatesSite Not Available
GSK Investigational Site
Tomball, Texas 77375
United StatesSite Not Available
GSK Investigational Site
Kaysville, Utah 84037
United StatesSite Not Available
GSK Investigational Site
Layton, Utah 84041
United StatesSite Not Available
GSK Investigational Site
Murray, Utah 84107
United StatesSite Not Available
GSK Investigational Site
Orem, Utah 84057
United StatesSite Not Available
GSK Investigational Site
Provo, Utah 84604
United StatesSite Not Available
GSK Investigational Site
Roy, Utah 84067
United StatesSite Not Available
GSK Investigational Site
South Jordan, Utah 84095
United StatesSite Not Available
GSK Investigational Site
West Jordan, Utah 84088
United StatesSite Not Available
GSK Investigational Site
Charlottesville, Virginia 22902
United StatesSite Not Available
GSK Investigational Site
Marshfield, Wisconsin 54449
United StatesSite Not Available
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