Journal article

Safety and immunogenicity of RV3-BB human neonatal rotavirus vaccine administered at birth or in infancy: A randomised, double-blind, placebo-controlled trial

JE Bines, M Danchin, P Jackson, A Handley, E Watts, KJ Lee, A West, D Cowley, MY Chen, GL Barnes, F Justice, JP Buttery, JB Carlin, RF Bishop, B Taylor, CD Kirkwood, K Boniface, N Bogdanovic-Sakran, D Pavlic, W Siero Show all

Lancet Infectious Diseases | ELSEVIER SCI LTD | Published : 2015

Abstract

Background: Despite the success of rotavirus vaccines, suboptimal vaccine efficacy in regions with a high burden of disease continues to present a challenge to worldwide implementation. A birth dose strategy with a vaccine developed from an asymptomatic neonatal rotavirus strain has the potential to address this challenge and provide protection from severe rotavirus disease from birth. Methods: This phase 2a randomised, double-blind, three-arm, placebo-controlled safety and immunogenicity trial was undertaken at a single centre in New Zealand between Jan 13, 2012, and April 17, 2014. Healthy, full-term (≥36 weeks gestation) babies, who weighed at least 2500 g, and were 0-5 days old at the ti..

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