Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Intervention: Rotarix ™; Placebo
Intervention description: Two oral doses; Two oral doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 684.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastroenteritis

Summary:

      The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human
      rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately
      6-12 weeks at the time of first vaccination.
    

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 to 12 weeks of age at the time of the first
             dose of the vaccination.

          -  Written informed consent obtained from the parents or guardians of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.

          -  Subjects for whom the vaccination history is available from vaccination diary cards or
             medical charts.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs since birth.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the first dose of vaccine with the exception of the routine infant
             vaccines.

          -  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.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Gastroenteritis (GE) within 7 days preceding the study vaccine administration.

          -  Previous confirmed occurrence of RV GE.

          -  Previous vaccination with rotavirus vaccine or planned use during the study period.