Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: Rotarix™; Placebo
Intervention description: Oral administration, 2 doses; Oral administration, 2 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8687.0
Sex: All
Minimum age: 2 Years
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotavirus Gastroenteritis; Human rotavirus vaccine, efficacy, infants

Summary:

      This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine
      efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in
      infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following
      schedules:

      at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or
      rota-030.

      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.

          -  A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan
             or 11 to 17 weeks of age in Singapore at the time of the first vaccination according
             to the country recommendations for the routine vaccination schedules.

          -  Written informed consent obtained from the parent or guardian of the subject, prior
             any study procedure.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        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 placebo,
             or planned use during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Child is unlikely to remain in the study area for the duration of the study

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  History of allergic disease or reaction likely to be exacerbated by any component of
             the vaccine.

          -  Administration of immunoglobulins and/or blood products since birth or planned
             administration during the study period. Oral intake of immunoglobulins is allowed.

          -  Any clinically significant history of chronic gastrointestinal disease including any
             uncorrected congenital malformation of the gastrointestinal tract or other serious
             medical condition as determined by the investigator.

          -  First or second degree of consanguinity of parents.