None listed
Conditions
Brief summary
A phase I clinical trial completed in Melbourne in 2011 found the RV3-BB vaccine to be well-tolerated in adults, children and babies 6-8 weeks of age. The aim of this phase IIa trial is to determine the extent of the immune response (or protection) that is created in babies receiving the vaccine. We are including newborn babies in this trial, as we believe receiving this vaccine at birth will offer the earliest and possibly greatest protection. We are inviting 93 Dunedin families, with newborn babies to take part in this trial. Each of the babies will be randomly assigned to groups, so that two thirds of the babies will receive 3 doses of oral RV3 vaccine and one third of the babies will receive oral doses of placebo. In total each baby’s involvement will include 7 visits, with the first visit in the first 5 days of the baby’s life, and the final visit at approximately 6 months of age.
Interventions
Each dose of RV3-BB rotavirus vaccine is 1ml sterile cell-free aqueous solution for oral administration, containing RV3-BB live naturally attenuated human rotavirus particles (at a concentration of 8.3E6 FFU/ml), in cell culture medium containing 10% sucrose.
Neonatal Schedule Arm participants will receive three 1ml doses of RV3-BB rotavirus vaccine, with the 1st dose administered at 0-5 days of age, followed by doses at approximately 9 weeks of age and approximately 15 weeks of age. To maintai
Each dose of RV3-BB rotavirus vaccine is 1ml sterile cell-free aqueous solution for oral administration, containing RV3-BB live naturally attenuated human rotavirus particles (at a concentration of 8.3E6 FFU/ml), in cell culture medium containing 10% sucrose. Neonatal Schedule Arm participants will receive three 1ml doses of RV3-BB rotavirus vaccine, with the 1st dose administered at 0-5 days of age, followed by doses at approximately 9 weeks of age and approximately 15 weeks of age. To maintain blinding with the infant schedule arm, the participants in this arm will receive a 1ml dose of placebo at the end of the treatment period (approximately 23 weeks of age). Infant Schedule Arm participants will receive three 1ml doses of RV3-BB rotavirus vaccine, with the 1st dose administered at approximately 9 weeks of age, followed by doses at approximately 15 weeks of age and approximately 23 weeks of age. To maintain blinding with the neonatal schedule arm, participants in this arm will receive a 1ml dose of placebo at 0-5 days of age.
Sponsors
Murdoch Children's Research Institute (MCRI)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 5 Days
Healthy volunteers
Yes
Inclusion criteria
healthy, full-term infant, 0-5 days of age.
Exclusion criteria
Moderate or severe illness, major congenital malformations or genetically determined disease, known or suspected disease of the immune system, household member with severe immunosuppression, exposure to the following in the 4 weeks prior to enrolment (including gestation): glucocorticosteroids, cytotoxic drugs or blood products. Intent to immunise with an investigational vaccine (during the study), or other rotavirus vaccine.
Outcome results
None listed