a phase ii dose-ranging study of oral rv3-bb rotavirus vaccine

Conditions: Rotavirus Infections

Summary: 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.

Eligibility criteria:
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.

Keywords: dose ranging neonatal vaccine rv3-bb vaccine