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

A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine will be assessed along with cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule.

The safety and tolerability of RV3-BB when administered as an infant or as a neonatal schedule will be described.

Inclusion Criteria:

• Neonate is less than 6 days (≤144 hours) of age at the time of first dose.
• 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.
• Neonate birth weight 2500-4000g inclusive.
• Neonate's parents/guardians expect to be available for the duration of the study, and agree to adhere to all protocol requirements.
• Neonate's parents/guardians have provided written informed consent prior to study-related procedures being performed.

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.