Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials

作者：Saad B. Omer, Dayna R Clark, Shabir A. Madhi, Milagritos D. Tapia, Marta C. Nunes, Clare Cutland, Eric A. F. Simões, Anushka Aqil, Joanne Katz, James M. Tielsch, Mark C. Steinhoff, Niteen Wairagkar, William C. Blackwelder, Joseph Bresee, Flanon Coulibaly, Boubacar Diallo, Fatoumata Diallo, Wilbur Chen, Moussa Doumbia, Fadima Cheick Haidara, Adama Mamby Keita, Alexander Klimov, Mamoudou Kodio, Karen Kotloff, Myron M. Levine, Vladimir Mishcherkin, Uma Onwuchekwa, Sandra Panchalingam, Marcela F. Pasetti, Doh Sanogo, Samba O. Sow, Milagritos D. Tapia, Boubou Tamboura, Ibrahim Tégueté, Sharon M. Tennant, Awa Traoré, John J. Treanor, Janet A. Englund, Joanne Katz, Subarna K. Khatry, Jane Kuypers, Steven C. LeClerq, Luke C. Mullany, Laxman Shrestha, Mark C. Steinhoff, James M. Tielsch, Peter V. Adrian, Clare Cutland, Andrea Hugo, Stephanie Jones, Locadiah Kuwanda, Keith P. Klugman, Shabir A. Madhi, Kathleen M. Neuzil, Nadia van Niekerk, Marta C. Nunes, Justin R. Ortiz, Eric A. F. Simões, Florette K. Treurnicht, Marietjie Venter, Avy Violari, Adriana Weinberg · 发表于：The Lancet Respiratory Medicine · 年份：2020 · DOI：10.1016/s2213-2600(19)30479-5 · 被引用次数：84 · 研究领域：Influenza Virus Research Studies、COVID-19 Impact on Reproduction、Bacterial Infections and Vaccines

BACKGROUND: Maternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age. METHODS: We did a pooled analysis of three randomised controlled trials done in Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013). Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov, numbers NCT01430689, NCT01034254, and NCT02465190. FINDINGS: 10 002 women and 9800 liveborn inf...