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Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>We report adverse birth events as secondary outcomes from the \u2018PneuMum\u2019 randomised controlled trial of 23\u2010valent pneumococcal polysaccharide vaccination (23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content>) in pregnancy (August 2006\u2013January 2011).<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>Australian Aboriginal women aged 17\u201339\u00a0years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content> or no 23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content> in pregnancy at 30\u201336\u00a0weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (<jats:styled-content style=\"fixed-case\">LBW<\/jats:styled-content>), and small for gestational age (<jats:styled-content style=\"fixed-case\">SGA<\/jats:styled-content>) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (<jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content>s) were calculated on an intention\u2010to\u2010treat basis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 227 enrolled participants, 75 (33%) received 23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content> in pregnancy. Risk differences in adverse birth outcomes between 23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content> vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (<jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content> 2.79; 95%<jats:styled-content style=\"fixed-case\"> CI<\/jats:styled-content> 0.94\u20138.32) <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.07; <jats:styled-content style=\"fixed-case\">LBW<\/jats:styled-content> 9% vs 5% (<jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content> 2.09; 95%<jats:styled-content style=\"fixed-case\"> CI<\/jats:styled-content> 0.76\u20135.78) <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.15; and <jats:styled-content style=\"fixed-case\">SGA<\/jats:styled-content> 15% vs 17% (<jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content> 1.02; 95%<jats:styled-content style=\"fixed-case\"> CI<\/jats:styled-content> 0.50\u20132.06) <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.96. There were no stillbirths.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>We found a numerically higher rate of preterm births among women who received 23v<jats:styled-content style=\"fixed-case\">PPV<\/jats:styled-content> in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ajo.13002","type":"journal-article","created":{"date-parts":[[2019,6,14]],"date-time":"2019-06-14T09:40:09Z","timestamp":1560505209000},"page":"82-87","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Birth outcomes in Aboriginal mother\u2013infant pairs from the Northern Territory, Australia, who received 23\u2010valent polysaccharide pneumococcal vaccination during pregnancy, 2006\u20132011: The PneuMum randomised controlled trial"],"prefix":"10.1111","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8580-9551","authenticated-orcid":false,"given":"Lisa","family":"McHugh","sequence":"first","affiliation":[{"name":"Menzies School of Health Research Charles Darwin University Tiwi Northern Territory Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Binks","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research Charles Darwin University Tiwi Northern Territory Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"Ware","sequence":"additional","affiliation":[{"name":"Menzies Health Institute Queensland Griffith University Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Snelling","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research Charles Darwin University Tiwi Northern Territory Australia"},{"name":"Wesfarmers Centre of Vaccines and Infectious Diseases Telethon Kids Institute University of Western Australia Perth Western Australia Australia"},{"name":"Department of Infectious Diseases Perth Children's Hospital Perth Western Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Nelson","sequence":"additional","affiliation":[{"name":"Top End Health Service Top End West Northern Territory Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Nelson","sequence":"additional","affiliation":[{"name":"Menzies School of Health Research Charles Darwin University Tiwi Northern Territory Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Dunbar","sequence":"additional","affiliation":[{"name":"Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care Queensland Health Inala Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. 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