Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial

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http://hdl.handle.net/10138/313609

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Vesikari , T , Virta , M , Heinonen , S , Eymin , C , Lavis , N , Chabanon , A L & Gresset-Bourgeois , V 2019 , ' Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial ' , Human Vaccines & Immunotherapeutics , vol. 16 , no. 3 , pp. 623-629 . https://doi.org/10.1080/21645515.2019.1667202

Title: Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial
Author: Vesikari, Timo; Virta, Miia; Heinonen, Seppo; Eymin, Cécile; Lavis, Nathalie; Chabanon, Anne Laure; Gresset-Bourgeois, Viviane
Contributor: University of Helsinki, Department of Obstetrics and Gynecology
Date: 2019-10-07
Number of pages: 7
Belongs to series: Human Vaccines & Immunotherapeutics
ISSN: 2164-5515
URI: http://hdl.handle.net/10138/313609
Abstract: ABSTRACTVaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 ? 7.7] vs. 3.4 [95% CI: 2.7 ? 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 ? 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.
Subject: 3123 Gynaecology and paediatrics
Immunization
influenza vaccines
newborn infant
pregnancy
safety
seasonal influenza
transplacental antibody transfer
vaccination
TO-LOT CONSISTENCY
MATERNAL IMMUNIZATION
RESPIRATORY ILLNESS
PHASE 4
EPIDEMIOLOGY
PREVENTION
PROTECTION
OUTCOMES
CHILDREN
INFANTS
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