biostudies-literatureSteinhoff MCCenters for Disease Control and PreventionNIAID NIH HHSBill and Melinda Gates Foundation981-989https://www.ebi.ac.uk/biostudies/studies/S-EPMC5573632biostudies-literatureUnknown17(9)<h4>Background</h4>Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year.<h4>Methods</h4>In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal. We randomised mothers 1:1 to receive seasonally recommended trivalent inactivated influenza vaccine or saline placebo in blocks of eight, stratified by gestational age at enrolment (17-25 weeks vs 26-34 weeks). Women were eligible if they were married, 15-40 years of age, 17-34 weeks' gestation at enrolment, and The Lancet. Infectious diseasesYear-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial.PMC5573632L30 AI10783350274K23 AI103105Steinhoff MCChu HYReedy AMKuypers JTielsch JMShrestha LEnglund JAKatz JKhatry SKKozuki NStewart LMullany LCLeClerq SCMcNeal MfalseYear-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial.<h4>Background</h4>Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year.<h4>Methods</h4>In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal. We randomised mothers 1:1 to receive seasonally recommended trivalent inactivated influenza vaccine or saline placebo in blocks of eight, stratified by gestational age at enrolment (17-25 weeks vs 26-34 weeks). Women were eligible if they were married, 15-40 years of age, 17-34 weeks' gestation at enrolment, and 2017-01-01T00:00:00Z2017 Sep2026-05-04T15:16:46.389Z2019-03-26T23:53:49ZS-EPMC55736322852233810.1016/S1473-3099(17)30252-910.1016/s1473-3099(17)30252-9