Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

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.
• •History of use of experimental rotavirus vaccine.
• •Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• •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).
• •Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
• •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• •Previous confirmed occurrence of RV GE.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
• •A family history of congenital or hereditary immunodeficiency.
• •Acute disease at the time of enrolment.
• •Gastroenteritis within 7 days preceding the study vaccine administration.
• •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.