Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

Inclusion Criteria for Adults: * Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator. * Subjects have been informed properly regarding the study and signed the informed consent form. * Subject will commit to comply with the instructions of the investigator and the schedule of the trial. Inclusion Criteria for Children: * Healthy Children as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator. * Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form * Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. Inclusion Criteria for Neonates: * Neonate 0-5 days of age at the time of first dose, with cord blood available * Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator. * The neonate was born full term (minimum of 36 completed weeks and maximum of 42 completed weeks gestation). * Neonate birth weight 2500-4000 g inclusive. * Parents or guardians have been informed properly regarding the study and signed the informed consent form * Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial Exclusion Criteria for Adults: * Subject concomitantly enrolled or scheduled to be enrolled in another trial * Any direct relatives relationship with the study team. * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment. * Known history of allergy to any component of the vaccines * Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy) * Gastroenteritis in the 24 hours preceding enrollment. * History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. * Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant). * Subject consuming or expect to consume a probiotics within one week before and after vaccination * Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. * Pregnancy \& lactation (Adults). * Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization. * Subject planning to move from the study area before the end of study period. Exclusion Criteria for Children: * Subject concomitantly enrolled or scheduled to be enrolled in another trial * Any direct relatives relationship with the study team * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment * Known history of allergy to any component of the vaccines * Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy) * Gastroenteritis in the 24 hours preceding enrollment. * Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception. * History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. * Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant). * Subjects consuming or expect to consume a probiotics within one week before and after vaccination. * Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. * Individuals who have previously received any rotavirus vaccine. * Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization. * Subject planning to move from the study area before the end of study period Exclusion Criteria for Neonates: * Subject concomitantly enrolled or scheduled to be enrolled in another trial. * Any direct relatives relationship with the study team. * Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment. * Subject with known or suspected history of allergy to any component of the vaccines. * Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection. * Subject with known or suspected major congenital malformations or genetically determined disease. * Subject with intussusception. * Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. * Subject with a known or suspected disease of the immune system or those who has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid. * Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of study. * Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. * Subject immunized with non- EPI vaccines. * Gastroenteritis in the 24 hours preceding enrollment. * Subject planning to move from the study area before the end of study period.