A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Intervention: RV3-BB; Placebo
Intervention description: Oral administration; Oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 711.0
Sex: All
Minimum age: 0 Days
Maximum age: 18 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dose ranging; Neonatal vaccine; RV3-BB vaccine

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.
    

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.