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AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial
Background. This phase 2/3, randomized, placebo-controlled, observer-blinded study assessed the immunogenicity, reactogenicity, and safety of an inactivated, split-virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years. Methods. Children received 2 influenza va...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Oxford University Press
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4319481/ https://www.ncbi.nlm.nih.gov/pubmed/25293368 http://dx.doi.org/10.1093/infdis/jiu548 |
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author | Kosalaraksa, Pope Jeanfreau, Robert Frenette, Louise Drame, Mamadou Madariaga, Miguel Innis, Bruce L. Godeaux, Olivier Izurieta, Patricia Vaughn, David W. |
author_facet | Kosalaraksa, Pope Jeanfreau, Robert Frenette, Louise Drame, Mamadou Madariaga, Miguel Innis, Bruce L. Godeaux, Olivier Izurieta, Patricia Vaughn, David W. |
author_sort | Kosalaraksa, Pope |
collection | PubMed |
description | Background. This phase 2/3, randomized, placebo-controlled, observer-blinded study assessed the immunogenicity, reactogenicity, and safety of an inactivated, split-virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years. Methods. Children received 2 influenza vaccine doses 21 days apart, each containing 1.9 µg of hemagglutinin and AS03(B) adjuvant (5.93 mg of α-tocopherol). The randomization ratio was 8:3 for vaccine to placebo, with equal allocation between 3 age strata (6–35 months, 3–8 years, and 9–17 years). Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees, at day 182 for half, and at day 385 for the remaining half. Reactogenicity after each dose and safety up to 1 year after vaccination were evaluated. Results. Within each age stratum, the lower limit of the 98.3% confidence interval for the day 42 seroprotection rate was ≥70%, thus fulfilling the US and European licensure criteria. The immune responses elicited by vaccine persisted well above baseline levels for 1 year. The vaccine was more reactogenic than placebo, but no major safety concerns were identified. Conclusions. AS03(B)-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied. Clinical Trials Registration. NCT01310413. |
format | Online Article Text |
id | pubmed-4319481 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-43194812015-02-24 AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial Kosalaraksa, Pope Jeanfreau, Robert Frenette, Louise Drame, Mamadou Madariaga, Miguel Innis, Bruce L. Godeaux, Olivier Izurieta, Patricia Vaughn, David W. J Infect Dis Major Articles and Brief Reports Background. This phase 2/3, randomized, placebo-controlled, observer-blinded study assessed the immunogenicity, reactogenicity, and safety of an inactivated, split-virion H5N1 influenza vaccine (A/Indonesia/5/2005) in children aged 6 months through 17 years. Methods. Children received 2 influenza vaccine doses 21 days apart, each containing 1.9 µg of hemagglutinin and AS03(B) adjuvant (5.93 mg of α-tocopherol). The randomization ratio was 8:3 for vaccine to placebo, with equal allocation between 3 age strata (6–35 months, 3–8 years, and 9–17 years). Immunogenicity against the vaccine strain was assessed 21 days after the first and second vaccine doses for all vaccinees, at day 182 for half, and at day 385 for the remaining half. Reactogenicity after each dose and safety up to 1 year after vaccination were evaluated. Results. Within each age stratum, the lower limit of the 98.3% confidence interval for the day 42 seroprotection rate was ≥70%, thus fulfilling the US and European licensure criteria. The immune responses elicited by vaccine persisted well above baseline levels for 1 year. The vaccine was more reactogenic than placebo, but no major safety concerns were identified. Conclusions. AS03(B)-adjuvanted H5N1 influenza vaccine was immunogenic and showed an acceptable safety profile in all age groups studied. Clinical Trials Registration. NCT01310413. Oxford University Press 2015-03-01 2014-10-06 /pmc/articles/PMC4319481/ /pubmed/25293368 http://dx.doi.org/10.1093/infdis/jiu548 Text en © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. 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-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com. This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections. |
spellingShingle | Major Articles and Brief Reports Kosalaraksa, Pope Jeanfreau, Robert Frenette, Louise Drame, Mamadou Madariaga, Miguel Innis, Bruce L. Godeaux, Olivier Izurieta, Patricia Vaughn, David W. AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title | AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title_full | AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title_fullStr | AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title_full_unstemmed | AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title_short | AS03(B)-Adjuvanted H5N1 Influenza Vaccine in Children 6 Months Through 17 Years of Age: A Phase 2/3 Randomized, Placebo-Controlled, Observer-Blinded Trial |
title_sort | as03(b)-adjuvanted h5n1 influenza vaccine in children 6 months through 17 years of age: a phase 2/3 randomized, placebo-controlled, observer-blinded trial |
topic | Major Articles and Brief Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4319481/ https://www.ncbi.nlm.nih.gov/pubmed/25293368 http://dx.doi.org/10.1093/infdis/jiu548 |
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