OTHER NCT03483116.
Trial name or title | "A Phase II Randomized, Double Blind, Parallel Group Dose‐ranging Study of Oral RV3‐BB Rotavirus Vaccine" |
Methods | Phase II randomized, controlled trial. Double‐blind |
Participants |
Number: 688 Description: up to 18 weeks (Child) |
Interventions | 1. RV3‐BB 2. Placebo |
Outcomes | 1.Cumulative anti‐rotavirus serum IgA response 2. Cumulative vaccine take and components of vaccine take (serum anti rotavirus IgA response or shedding of RV3‐BB) 3. Adverse events 4. Serious adverse events 5. Diarrhoea |
Starting date | April 2018 Completion: May 2019 (primary completion date estimated), August 2019 (Estimated study completion date) |
Contact information | Julie Bines, MD, +61393454107, julie.bines@mcri.edu.au |
Notes |
Location: Malawi Registration number: NCT03483116 Source of funding: Murdoch Childrens Research Institute |