Eligibility Check
Inclusion criteria
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)
boolean
A male or female between, and including, 6 weeks +/- 1 week of age at the tiem of Visit 1. (2)
boolean
Written informed consent obtained from the parent or guardian of the subject. (3)
boolean
Free of obvious health problems as established by medical history and clinical examination before entering into the study. (4)
boolean
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 planned use during the study period. (5)
boolean
Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. (6)
boolean
Chronic administration (defined as more than 14 days) of major immunosuppressants (equivalent to prednisone 1mg/kg/day) since birth. (Topical steroids are allowed.) (7)
boolean
Malnutrition (< 3Z score weight for age). (8)
boolean
History of/or intercurrent polio disease. (9)
boolean
Previous confirmed occurrence of RV GE. (10)
boolean
History of use of experimental RV vaccine. (11)
boolean
Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the CRF). (12)
boolean
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator. (13)
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (14)
boolean
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. (15)
boolean
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low- grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) (16)
boolean
A family history of congenital or hereditary immunodeficiency. (17)
boolean
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. (18)
boolean
History of any neurologic disorders or seizures. (19)
boolean
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. (20)
boolean