Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

Exclusion Criteria

• •Child in care.
• •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• •Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
• •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
• •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.
• •Previous vaccination against rotavirus.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• •Family history of congenital or hereditary immunodeficiency.
• •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• •Major congenital defects or serious chronic illness.
• •Acute disease and/or fever at the time of enrolment.
• •Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
• •Gastroenteritis within 7 days preceding the study vaccine administration.
• •Previous confirmed occurrence of Rotavirus gastroenteritis.