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. 2019 Oct 28;2019(10):CD008521. doi: 10.1002/14651858.CD008521.pub5

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