to test 2 doses of gsk biologicals' oral live attenuated human rotavirus (hrv) vaccine in healthy infants in co-administration with specific childhood vaccines

Conditions: Infections, Rotavirus

Summary: the main objectives of this study is to determine vaccine efficacy against any rotavirus (rv) gastroenteritis (ge) during the first efficacy period.

the study has two groups: group hrv and group placebo. two oral doses administered to healthy infants who are 6-14 weeks of age at the time of dose 1, according to a 0, 1 to 2-month schedule. routine epi vaccinations are given at the discretion of the investigator and according to local national plans of immunisation schedule in each participating country.

Eligibility criteria:
inclusion criteria: * healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight \> 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). 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. * 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. * chronic administration (defined as more than 14 days) of immunosuppressants since birth. (topical steroids are allowed.) * history of diphtheria, tetanus, pertussis, hib disease and/ or hepatitis b disease (in all subjects). only for subjects in spain: history of meningococcal group c disease. only for subjects in france and germany: history of disease caused by streptococcus pneumoniae. * history of use of experimental rotavirus vaccine. * previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b (in all subjects). only for subjects in spain: previous vaccination against meningococcal group c. only for subjects in france and germany: previous vaccination against streptococcus pneumoniae. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gi tract, is or other medical condition determined to be serious by the investigator. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * 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).) * gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). * a family history of congenital or hereditary immunodeficiency. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period. * history of any neurologic disorders or seizures. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.