Journal article

PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia

Michael J Binks, Sarah A Moberley, Anne Balloch, Amanda J Leach, Sandra Nelson, Kim M Hare, Cate Wilson, Peter S Morris, Jane Nelson, Mark D Chatfield, Mimi LK Tang, Paul Torzillo, Jonathan R Carapetis, E Kim Mulholland, Ross M Andrews

VACCINE | ELSEVIER SCI LTD | Published : 2015

Abstract

BACKGROUND: We assessed maternal 23-valent pneumococcal polysaccharide (23vPPV) vaccine efficacy (VE) against middle ear disease and pneumococcal carriage amongst Australian Indigenous infants. METHODS: In an open label, allocation concealed, outcome-assessor blinded, community stratified, randomised controlled trial, healthy pregnant Indigenous women aged 17-39 years in the Northern Territory of Australia received the 23vPPV (1:1:1) at: 30-36 weeks gestation, birth, or were unvaccinated (ClinicalTrials.gov NCT00714064). Co-primary outcomes were the point prevalences of infant middle ear disease and 23vPPV-type carriage at age 7 months. RESULTS: The consent rate was 50% (313/632). Among 227 ..

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