PMID- 31198999 OWN - NLM STAT- MEDLINE DCOM- 20201130 LR - 20211204 IS - 1479-828X (Electronic) IS - 0004-8666 (Linking) VI - 60 IP - 1 DP - 2020 Feb TI - Birth outcomes in Aboriginal mother-infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006-2011: The PneuMum randomised controlled trial. PG - 82-87 LID - 10.1111/ajo.13002 [doi] AB - BACKGROUND: Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking. AIMS: We report adverse birth events as secondary outcomes from the 'PneuMum' randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006-January 2011). MATERIALS AND METHODS: Australian Aboriginal women aged 17-39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30-36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis. RESULTS: Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94-8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76-5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50-2.06) P = 0.96. There were no stillbirths. CONCLUSIONS: We found a numerically higher rate of preterm births among women who received 23vPPV 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. CI - (c) 2019 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. FAU - McHugh, Lisa AU - McHugh L AUID- ORCID: 0000-0001-8580-9551 AD - Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia. FAU - Binks, Michael AU - Binks M AD - Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia. FAU - Ware, Robert S AU - Ware RS AD - Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. FAU - Snelling, Tom AU - Snelling T AD - Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia. AD - Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia. AD - Department of Infectious Diseases, Perth Children's Hospital, Perth, Western Australia, Australia. FAU - Nelson, Sandra AU - Nelson S AD - Top End Health Service, Top End West, Northern Territory, Australia. FAU - Nelson, Jane AU - Nelson J AD - Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia. FAU - Dunbar, Melissa AU - Dunbar M AD - Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Queensland Health, Inala, Queensland, Australia. FAU - Mulholland, E Kim AU - Mulholland EK AD - Murdoch Children's Research Institute, Melbourne, Victoria, Australia. AD - Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia. AD - London School of Hygiene and Tropical Medicine, London, UK. FAU - Andrews, Ross M AU - Andrews RM AD - Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia. AD - National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australian Capital Territory, Australia. LA - eng GR - Menzies School of Health Research Enhanced Living Scholarship/International GR - Charles Darwin University Australian Postgraduate Award/International GR - 350499/National Health and Medical Research Council/International GR - 490320/National Health and Medical Research Council/International PT - Journal Article PT - Randomized Controlled Trial DEP - 20190614 PL - Australia TA - Aust N Z J Obstet Gynaecol JT - The Australian & New Zealand journal of obstetrics & gynaecology JID - 0001027 RN - 0 (23-valent pneumococcal capsular polysaccharide vaccine) RN - 0 (Pneumococcal Vaccines) SB - IM MH - Adolescent MH - Adult MH - Female MH - Gestational Age MH - Humans MH - Infant, Low Birth Weight MH - Infant, Small for Gestational Age MH - Native Hawaiian or Other Pacific Islander/*statistics & numerical data MH - Northern Territory/epidemiology MH - Pneumococcal Vaccines/administration & dosage/*adverse effects MH - Population Groups/statistics & numerical data MH - Pregnancy MH - Pregnancy Outcome/*epidemiology MH - Premature Birth/*epidemiology MH - Vaccination/adverse effects MH - Young Adult OTO - NOTNLM OT - Aboriginal OT - pneumococcal OT - pregnancy OT - safety OT - vaccination EDAT- 2019/06/15 06:00 MHDA- 2020/12/01 06:00 CRDT- 2019/06/15 06:00 PHST- 2019/02/06 00:00 [received] PHST- 2019/04/23 00:00 [accepted] PHST- 2019/06/15 06:00 [pubmed] PHST- 2020/12/01 06:00 [medline] PHST- 2019/06/15 06:00 [entrez] AID - 10.1111/ajo.13002 [doi] PST - ppublish SO - Aust N Z J Obstet Gynaecol. 2020 Feb;60(1):82-87. doi: 10.1111/ajo.13002. Epub 2019 Jun 14.