Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
Condition: Rotavirus
Intervention: HRV Liquid; HRV Lyophilized
Intervention description: Two doses administered orally according to a 0, 1-month schedule.; Two doses administered orally according to a 0, 1-month schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 451.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotarix; HRV; Healthy infants; Liquid formulation; Lyophilized formulation; Human rotavirus vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK
      Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when
      administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose
      one, with no previous history of rotavirus illness or vaccination.

      While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008,
      this study is conducted to generate additional clinical data for the liquid formulation of
      the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines
      (NDAC-Vaccines) of Drug Controller General of India (DCGI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/ Legally Acceptable Representative (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) of the subject prior to
             performing any study specific procedure.

          -  A male or female between, and including, 6 and 10 weeks of age at the time of the
             first vaccination.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Birth weight >2000 grams.

        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 vaccine (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 any chronic drug therapy to be continued 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, according to the local immunization practice.

          -  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 product.

          -  History of confirmed RV GE.

          -  Previous vaccination against RV.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, (including
             Severe Combined Immunodeficiency [SCID] disorder) based on medical history and
             physical examination.

          -  Uncorrected congenital malformation (such as Meckel's diverticulum) of the
             gastrointestinal tract that would predispose for Intussusception (IS).

          -  History of IS.

          -  Very prematurely born infants (born ≤28 weeks of gestation).

          -  Hypersensitivity to latex.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment. This warrants deferral of
             vaccination.

               -  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 or the
                  rectum.

               -  Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
                  infection) without fever may, be enrolled at the discretion of the investigator.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or medical history.

          -  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 (e.g., infliximab).

          -  GE within 7 days preceding the study vaccine administration (warrants deferral of the
             vaccination).