To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1009.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is planned to evaluate the safety (in terms of occurrence of any serious adverse
      events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to
      develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants
      aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and
      in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study
      will be performed in four European countries (France, Poland, Spain, and Portugal). The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 male or female infant between, and including, 6 and 14 weeks (42 - 104 days)
             of age at the time of first study vaccination in Portugal, France and Poland. A male
             or female infant between, and including, 6 and 12 weeks of age at the time of first
             study vaccination in Spain.

          -  Medically stable pre-term infants, born within a gestational period of 27 -36 weeks.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Planned to be discharged from hospital's neonatal stay on or before the day of the
             first HRV vaccine/Placebo administration.

        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.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Planned administration/ administration of a vaccines not foreseen by the study
             protocol from birth till study end.

          -  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).

          -  Any clinically significant history of chronic gastrointestinal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness (subjects with severe
             broncho-pulmonary dysplasia requiring persistent oxygen-therapy will be excluded).

          -  History of any neurologic disorders or seizures. Grade I and II intra-ventricular
             bleeding are allowed.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins, and/or any blood products within one month (30
             days) preceding the first dose of study vaccines or planned administration during the
             study period. Monoclonal anti-RSV therapy/prophylaxis and recombinant erythropoietin
             are allowed.