A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Condition: Infections, Rotavirus
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Transmission; Gastroenteritis; Shedding; rotavirus; HRV vaccine

Summary:

      The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus)
      vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving
      placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a live twin living in the same household who is also enrolled in this
             study.

          -  Born after a gestation period of ≥32 weeks,

          -  Discharged from hospital neonatal care stay,

          -  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.

          -  A male or female between, and including, 6 and 14 weeks of age at the time of the
             first study vaccination.

          -  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 subjects.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Any clinically significant history of chronic gastrointestinal disease.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Contact with an immunosuppressed individual.

          -  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).

          -  Chronic administration of immunosuppressants since birth.

          -  Gastroenteritis within 7 days preceding the first study vaccine administration.

          -  Documented HIV-positive subject.