Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Intervention: Rotarix; Placebo
Intervention description: Two-dose oral vaccination.; Two-dose oral administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 765.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is undertaken to provide the regulatory authorities in Japan with immunogenicity,
      efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine,
      given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2
      months at the time of the first dose and previously uninfected with HRV. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of
             age at the time of the first vaccination.

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Born between a gestation period of 36 and 42 weeks inclusive.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use
             during the study period.

          -  History of use of experimental rotavirus vaccine.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  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 (pharmaceutical product or device).

          -  Uncorrected congenital malformation (such as Meckel's diverticulum) of the
             gastrointestinal tract that would predispose for intussusception.

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the gastrointestinal tract or other serious
             medical condition determined by the investigator.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Previous confirmed occurrence of RV GE.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination (no laboratory testing is required).

          -  A family history of congenital or hereditary immunodeficiency.

          -  Acute disease at the time of enrolment.

          -  Gastroenteritis within 7 days preceding the study vaccine administration.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.