Cargando…

MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico

The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvan...

Descripción completa

Detalles Bibliográficos
Autores principales: Cruz-Valdez, Aurelio, Valdez-Zapata, Gabriel, Patel, Sanjay S., Castelli, Flavia V., Garcia, Marcia G., Jansen, Wim T., Arora, Ashwani Kumar, Heijnen, Esther
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5806633/
https://www.ncbi.nlm.nih.gov/pubmed/28925801
http://dx.doi.org/10.1080/21645515.2017.1373227
_version_ 1783299160856854528
author Cruz-Valdez, Aurelio
Valdez-Zapata, Gabriel
Patel, Sanjay S.
Castelli, Flavia V.
Garcia, Marcia G.
Jansen, Wim T.
Arora, Ashwani Kumar
Heijnen, Esther
author_facet Cruz-Valdez, Aurelio
Valdez-Zapata, Gabriel
Patel, Sanjay S.
Castelli, Flavia V.
Garcia, Marcia G.
Jansen, Wim T.
Arora, Ashwani Kumar
Heijnen, Esther
author_sort Cruz-Valdez, Aurelio
collection PubMed
description The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014–2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV. Seroconversion was one of several secondary objectives. In total, 287 children were enrolled. The non-inferiority criteria for GMTs and seroconversion were met for aTIV for all 3 vaccine strains. Lower bounds of the 95% confidence intervals for all 3 aTIV:TIV vaccine ratios were >2, showing that the immunogenicity of aTIV was superior to that of TIV for all 3 strains. Solicited adverse events (AEs) were experienced more frequently with aTIV than TIV by younger children (aged 6 to <36 months), but were more frequent with TIV than aTIV in older children (aged 36 to <72 months) who had been vaccinated previously. More unsolicited AEs were associated with aTIV than the TIV. All AEs were of mild or moderate severity. No deaths, serious AEs, or AEs leading to premature withdrawal were reported. Overall, aTIV was highly immunogenic and was well tolerated in healthy children 6 to <72 months of age. These results indicate that aTIV may be a beneficial addition to national pediatric vaccination programs.
format Online
Article
Text
id pubmed-5806633
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Taylor & Francis
record_format MEDLINE/PubMed
spelling pubmed-58066332018-02-14 MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico Cruz-Valdez, Aurelio Valdez-Zapata, Gabriel Patel, Sanjay S. Castelli, Flavia V. Garcia, Marcia G. Jansen, Wim T. Arora, Ashwani Kumar Heijnen, Esther Hum Vaccin Immunother Research Paper The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014–2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV. Seroconversion was one of several secondary objectives. In total, 287 children were enrolled. The non-inferiority criteria for GMTs and seroconversion were met for aTIV for all 3 vaccine strains. Lower bounds of the 95% confidence intervals for all 3 aTIV:TIV vaccine ratios were >2, showing that the immunogenicity of aTIV was superior to that of TIV for all 3 strains. Solicited adverse events (AEs) were experienced more frequently with aTIV than TIV by younger children (aged 6 to <36 months), but were more frequent with TIV than aTIV in older children (aged 36 to <72 months) who had been vaccinated previously. More unsolicited AEs were associated with aTIV than the TIV. All AEs were of mild or moderate severity. No deaths, serious AEs, or AEs leading to premature withdrawal were reported. Overall, aTIV was highly immunogenic and was well tolerated in healthy children 6 to <72 months of age. These results indicate that aTIV may be a beneficial addition to national pediatric vaccination programs. Taylor & Francis 2018-01-03 /pmc/articles/PMC5806633/ /pubmed/28925801 http://dx.doi.org/10.1080/21645515.2017.1373227 Text en © 2018 The Author(s). Published with license by Taylor & Francis http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
spellingShingle Research Paper
Cruz-Valdez, Aurelio
Valdez-Zapata, Gabriel
Patel, Sanjay S.
Castelli, Flavia V.
Garcia, Marcia G.
Jansen, Wim T.
Arora, Ashwani Kumar
Heijnen, Esther
MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title_full MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title_fullStr MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title_full_unstemmed MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title_short MF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico
title_sort mf59-adjuvanted influenza vaccine (fluad®) elicits higher immune responses than a non-adjuvanted influenza vaccine (fluzone®): a randomized, multicenter, phase iii pediatric trial in mexico
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5806633/
https://www.ncbi.nlm.nih.gov/pubmed/28925801
http://dx.doi.org/10.1080/21645515.2017.1373227
work_keys_str_mv AT cruzvaldezaurelio mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT valdezzapatagabriel mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT patelsanjays mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT castelliflaviav mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT garciamarciag mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT jansenwimt mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT aroraashwanikumar mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico
AT heijnenesther mf59adjuvantedinfluenzavaccinefluadelicitshigherimmuneresponsesthananonadjuvantedinfluenzavaccinefluzonearandomizedmulticenterphaseiiipediatrictrialinmexico