作者
Kirsten P Perrett, Scott A Halperin, Terry Nolan, Cristina Martínez Pancorbo, Bruce Tapiero, Federico Martinón-Torres, Zbynek Stranak, Miia Virta, Otto G Vanderkooi, Pavel Kosina, Maria Begoña Encinas Pardilla, Ignacio Cristobal García, Gian Vincenzo Zuccotti, Lusine Kostanyan, Nadia Meyer, Maria Angeles Ceregido, Brigitte Cheuvart, Sherine O Kuriyakose, Manuel Marcos Fernández, Miguel Ángel Rodríguez Zambrano, Adrián Martín García, Juan Eloy Asenjo de La Fuente, Maria Dolores Camacho Marín, María de la Calle Fernández-Miranda, Yolanda Romero Espinar, Paola Giovanna Marchisio, Paolo Manzoni, Narcisa Mesaros
发表日期
2020/2/18
期刊
Vaccine
卷号
38
期号
8
页码范围
2095-2104
出版商
Elsevier
简介
Background
Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach.
Methods
This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27–36 weeks’ gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration …
学术搜索中的文章
KP Perrett, SA Halperin, T Nolan, CM Pancorbo… - Vaccine, 2020