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.