Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Intervention: HRV PCV-free liquid vaccine; Rotarix
Intervention description: Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally; Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 1612.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Healthy infants; Immunogenicity; Human Rotavirus (HRV)

Summary:

      The purpose of this study is to evaluate the clinical consistency of three production lots of
      the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus
      (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to
      the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity,
      reactogenicity and safety when administered as a two-dose vaccination in healthy infants
      starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the
      study.
    

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.

          -  Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable
             representatives) of the subject prior to performing any study specific procedure.

          -  A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at
             the time of the first study vaccination.

          -  Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6
             days).

          -  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 0), or planned use during the study period.

          -  Chronic administration 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
             in the period starting 30 days before the first dose of vaccine administration and
             ending at Visit 3, with the exception of the inactivated influenza vaccine, which is
             allowed at any time during the study and other licensed routine childhood
             vaccinations.

          -  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.

          -  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 RV.

          -  Previous confirmed occurrence of RVGE.

          -  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.

          -  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 (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.