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 (ACTRN12610000525088). A phase IIa clinical trial in Dunedin (ACTRN12611001212943) was designed to assess immunogenicity of the vaccine. The aim of this phase IIb trial is to determine the efficacy of the vaccine. Newborn babies are included in this trial to examine whether administering this vaccine at birth will offer the earliest and possibly greatest protection. 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 monthly visits and additional regular follow up until 18 months of age.
Interventions
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.
All participants will receive 4 doses of investigatonal product, at birth (0-5 days), 8-10 weeks, 14-16 weeks and 18-20 weeks of age.
- The neonatal schedule arm will receive active Investigational Product for the 1st, 2nd and 3rd doses and placebo fo
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. All participants will receive 4 doses of investigatonal product, at birth (0-5 days), 8-10 weeks, 14-16 weeks and 18-20 weeks of age. - The neonatal schedule arm will receive active Investigational Product for the 1st, 2nd and 3rd doses and placebo for the 4th dose - The infant schedule arm will receive placebo for the 1st dose and active Investigational Product for the 2nd, 3rd and 4th doses - The placebo schedule arm will receve placebo for all 4 doses.
Sponsors
Murdoch Children's Research Institute (MCRI)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 5 Days
Healthy volunteers
Yes
Inclusion criteria
Healthy full-term baby 0 - 5 days of age.
Exclusion criteria
Major congenital malformations or genetically determined disease, intussusception, immune system disease, prior receipt of (or exposure in utero to) immunosuppressive therapy, cytotoxic or hepatotoxic drugs, bleeding diathesis, significant evolving neurological disorder, previous anaphylactic reaction, contraindication of EPI vaccines or components, receipt of any other rotavirus vaccine, vomiting, diarrhoea or fever in 24 hours prior to first dose.
Outcome results
None listed