A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

Exclusion Criteria

• •Any medical, psychiatric, or social condition of a parent/guardian that in the opinion of the investigator would prevent the neonate's parents/guardians from giving proper informed consent or from complying with the study protocol.
• •Neonates with known or suspected major congenital malformations or genetically determined disease.
• •Neonates with intussusception.
• •Neonates with a known or suspected bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• •Neonates who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of the study is anticipated.
• •Neonates in whom Essential Programme Immunisation (EPI) vaccines or components are contraindicated.
• •Neonates who have received or who expect to receive during the study period, any rotavirus vaccine other than those which will be administered as part of this study.
• •Neonates who have ever received, or who are anticipated to receive during the study period, any investigational agent other than those which will be administered as part of this study.
• •Neonates with a previous anaphylactic reaction to any drug, vaccine or vaccine component.
• •Neonates with a significant evolving neurological disorder.
• •Neonates whose parents/guardians are site team employees with direct involvement with the investigators, or who are working on the study.
• •Neonates who have been exposed to immunosuppressive courses of glucocorticosteroids, cytotoxic drugs or blood products through prenatal exposure and/or breast milk in the four weeks prior to randomization.
• •Neonates with diarrhoea or vomiting in the 24 hours preceding randomisation.
• •Neonates with any moderate or severe illness, and/or who have a temperature of ≥37.5˚C axillary/oral or ≥38˚C rectal/tympanic within the 48 hours preceding randomization.