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
Condition: Rotavirus Infection; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Intervention: Rotarix; Pediarix; Hiberix; Prevenar 13
Intervention description: Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.; Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1280.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; lyophilized formulation; United States; Reactogenicity; Safety; Porcine circovirus -free; Human rotavirus vaccine; liquid formulation; Healthy infants

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 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.