Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

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.