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

Last updated: December 7, 2020
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Gastroenteritis

Treatment

N/A

Clinical Study ID

NCT03207750
201663
2016-003210-27
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

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

Total Participants: 1280
Study Start date:
September 14, 2017
Estimated Completion Date:
March 01, 2019

Connect with a study center

  • GSK Investigational Site

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • GSK Investigational Site

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • GSK Investigational Site

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • GSK Investigational Site

    Daly City, California 94015
    United States

    Site Not Available

  • GSK Investigational Site

    Oakland, California 94611
    United States

    Site Not Available

  • GSK Investigational Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • GSK Investigational Site

    West Covina, California 91790
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80922
    United States

    Site Not Available

  • GSK Investigational Site

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • GSK Investigational Site

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • GSK Investigational Site

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33142
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33617
    United States

    Site Not Available

  • GSK Investigational Site

    Nampa, Idaho 83686
    United States

    Site Not Available

  • GSK Investigational Site

    Bardstown, Kentucky 40004
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • GSK Investigational Site

    Frederick, Maryland 21702
    United States

    Site Not Available

  • GSK Investigational Site

    Fall River, Massachusetts 02721
    United States

    Site Not Available

  • GSK Investigational Site

    Bingham Farms, Michigan 48025
    United States

    Site Not Available

  • GSK Investigational Site

    Lincoln, Nebraska 68504
    United States

    Site Not Available

  • GSK Investigational Site

    Bronx, New York 10468
    United States

    Site Not Available

  • GSK Investigational Site

    Syracuse, New York 13202
    United States

    Site Not Available

  • GSK Investigational Site

    Boone, North Carolina 28607
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44121
    United States

    Site Not Available

  • GSK Investigational Site

    Dayton, Ohio 45406
    United States

    Site Not Available

  • GSK Investigational Site

    Grove City, Ohio 43123
    United States

    Site Not Available

  • GSK Investigational Site

    Hermitage, Pennsylvania 16148
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • GSK Investigational Site

    North Charleston, South Carolina 29406-9170
    United States

    Site Not Available

  • GSK Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • GSK Investigational Site

    Galveston, Texas 77555
    United States

    Site Not Available

  • GSK Investigational Site

    Tomball, Texas 77375
    United States

    Site Not Available

  • GSK Investigational Site

    Kaysville, Utah 84037
    United States

    Site Not Available

  • GSK Investigational Site

    Layton, Utah 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Murray, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    Orem, Utah 84057
    United States

    Site Not Available

  • GSK Investigational Site

    Provo, Utah 84604
    United States

    Site Not Available

  • GSK Investigational Site

    Roy, Utah 84067
    United States

    Site Not Available

  • GSK Investigational Site

    South Jordan, Utah 84095
    United States

    Site Not Available

  • GSK Investigational Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22902
    United States

    Site Not Available

  • GSK Investigational Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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