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
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 ..View full abstract
Awarded by National Health and Medical Research Council (NHMRC) of Australia
This work was supported by the National Health and Medical Research Council (NHMRC) of Australia (project grants 350499, 490320). Other than funding, the NHMRC had no involvement in the study.