Show simple item record

dc.contributor.authorPerrett, Kirsten P.
dc.contributor.authorHalperin, Scott A.
dc.contributor.authorNolan, Terry
dc.contributor.authorMartínez Pancorbo, Cristina
dc.contributor.authorTapiero, Bruce
dc.contributor.authorMartinón-Torres, Federico
dc.contributor.authorStranak, Zbynek
dc.contributor.authorVirta, Miia
dc.contributor.authorVanderkooi, Otto G.
dc.contributor.authorKosina, Pavel
dc.contributor.authorEncinas Pardilla, Maria Begoña
dc.contributor.authorCristóbal García, Ignacio 
dc.contributor.authorZuccotti, Gian Vincenzo
dc.contributor.authorKostanyan, Lusine
dc.contributor.authorMeyer, Nadia
dc.contributor.authorCeregido, Maria Angeles
dc.contributor.authorCheuvart, Brigitte
dc.contributor.authorKuriyakose, Sherine O.
dc.contributor.authorMarcos Fernández, Manuel
dc.contributor.authorRodríguez Zambrano, Miguel Ángel
dc.contributor.authorMartín García, Adrián
dc.contributor.authorAsenjo de la Fuente, Juan Eloy
dc.contributor.authorCamacho Marín, Maria Dolores
dc.contributor.authorFernández-Miranda, María de la Calle
dc.contributor.authorRomero Espinar, Yolanda
dc.contributor.authorGiovanna Marchisio, Paola
dc.contributor.authorManzoni, Paolo
dc.contributor.authorMesaros, Narcisa
dc.description.abstractBackground: 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-hourpostpartum 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 (GMC) ratios (Tdap/control) in cord blood were 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/ neonate-related AEs of interest were recorded. Results: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5–19.2) for anti-filamentous hemagglutinin, 20.7 (15.9–26.9) for anti-pertactin and 8.5 (7.0–10.2) for anti-pertussis toxoid. Rates of pregnancy-/ neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. Conclusions: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis
dc.rightsAtribución-NoComercial-SinDerivadas 3.0 España*
dc.subjectAdult formulation acellular pertussis vaccinespa
dc.subjectMaternal immunizationspa
dc.titleImmunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled
dc.description.extent502 KBspa

Files in this item

1.- Immunogenicity, transplacental ...501.2KbPDFView/Open

This item appears in the following Collection(s)

Show simple item record

Atribución-NoComercial-SinDerivadas 3.0 España
Except where otherwise noted, this item's license is described as Atribución-NoComercial-SinDerivadas 3.0 España