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...
Autores principales: | , , , , , , , |
---|---|
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 |