Journal article
Human neonatal rotavirus vaccine (RV3-BB) to target rotavirus from birth
JE Bines, J At Thobari, CD Satria, A Handley, E Watts, D Cowley, H Nirwati, J Ackland, J Standish, F Justice, G Byars, KJ Lee, GL Barnes, NS Bachtiar, A Viska Icanervilia, K Boniface, N Bogdanovic-Sakran, D Pavlic, RF Bishop, CD Kirkwood Show all
New England Journal of Medicine | MASSACHUSETTS MEDICAL SOC | Published : 2018
Open access
Abstract
BACKGROUND: A strategy of administering a neonatal rotavirus vaccine at birth to target early prevention of rotavirus gastroenteritis may address some of the barriers to global implementation of a rotavirus vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled trial in Indonesia to evaluate the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Healthy newborns received three doses of RV3-BB, administered according to a neonatal schedule (0 to 5 days, 8 weeks, and 14 weeks of age) or an infant schedule (8 weeks, 14 weeks, and 18 weeks of age), or placebo. The primary analysis was conducted in the per-protocol populat..
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Funding Acknowledgements
Supported by the Bill and Melinda Gates Foundation, the National Health and Medical Research Council, PT Bio Farma, and the Victorian Government's Operational Infrastructure Support Program.