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Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China

A split-virion trivalent inactivated influenza vaccine produced according to the Chinese pharmacopeia (Shz-IIV3) has been commercially available in China since 2014. Here, we describe the results of a phase IV open-label trial to describe the immunogenicity and safety of the 2014–2015 Northern Hemis...

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Autores principales: Mo, Zhaojun, Nong, Yi, Liu, Shuzhen, Shao, Ming, Liao, Xueyan, Go, Kerry, Lavis, Nathalie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489275/
https://www.ncbi.nlm.nih.gov/pubmed/28301266
http://dx.doi.org/10.1080/21645515.2017.1285475
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author Mo, Zhaojun
Nong, Yi
Liu, Shuzhen
Shao, Ming
Liao, Xueyan
Go, Kerry
Lavis, Nathalie
author_facet Mo, Zhaojun
Nong, Yi
Liu, Shuzhen
Shao, Ming
Liao, Xueyan
Go, Kerry
Lavis, Nathalie
author_sort Mo, Zhaojun
collection PubMed
description A split-virion trivalent inactivated influenza vaccine produced according to the Chinese pharmacopeia (Shz-IIV3) has been commercially available in China since 2014. Here, we describe the results of a phase IV open-label trial to describe the immunogenicity and safety of the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 in individuals ≥ 6 months of age. Subjects 6–35 months of age received 2 half-doses of Shz-IIV3 (0.25 ml) 28 d apart, and subjects ≥ 3 y of age received a single full dose (0.5 ml). The study included 602 subjects. Except for the A (H3N2) strain in subjects 3–17 years, geometric mean hemagglutination inhibition titer ratios were ≥ 10 and rates of seroconversion/significant increase in titer were ≥ 78% in all age groups. For the H3N2 strain in subjects 3–17 years, the geometric mean titer ratio was 3.8 and the rate of seroconversion/significant increase was 56%. Post-vaccination seroprotection rates were ≥ 88% for all strains in all age groups. The most common solicited reactions were injection-site pain/tenderness and fever, most of which were grade 1 and resolved within 3 d. Vaccine-related unsolicited adverse events were reported only by subjects 6–23 months, most of which were mild abnormal crying and irritability. No vaccine-related serious adverse events and no deaths were reported. No new safety signals or unexpected safety events occurred, although an immediate anaphylactic skin reaction occurred in one subject. This study confirmed that the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 was well tolerated and highly immunogenic in subjects ≥ 6 months of age.
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spelling pubmed-54892752017-07-05 Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China Mo, Zhaojun Nong, Yi Liu, Shuzhen Shao, Ming Liao, Xueyan Go, Kerry Lavis, Nathalie Hum Vaccin Immunother Research Papers A split-virion trivalent inactivated influenza vaccine produced according to the Chinese pharmacopeia (Shz-IIV3) has been commercially available in China since 2014. Here, we describe the results of a phase IV open-label trial to describe the immunogenicity and safety of the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 in individuals ≥ 6 months of age. Subjects 6–35 months of age received 2 half-doses of Shz-IIV3 (0.25 ml) 28 d apart, and subjects ≥ 3 y of age received a single full dose (0.5 ml). The study included 602 subjects. Except for the A (H3N2) strain in subjects 3–17 years, geometric mean hemagglutination inhibition titer ratios were ≥ 10 and rates of seroconversion/significant increase in titer were ≥ 78% in all age groups. For the H3N2 strain in subjects 3–17 years, the geometric mean titer ratio was 3.8 and the rate of seroconversion/significant increase was 56%. Post-vaccination seroprotection rates were ≥ 88% for all strains in all age groups. The most common solicited reactions were injection-site pain/tenderness and fever, most of which were grade 1 and resolved within 3 d. Vaccine-related unsolicited adverse events were reported only by subjects 6–23 months, most of which were mild abnormal crying and irritability. No vaccine-related serious adverse events and no deaths were reported. No new safety signals or unexpected safety events occurred, although an immediate anaphylactic skin reaction occurred in one subject. This study confirmed that the 2014–2015 Northern Hemisphere formulation of Shz-IIV3 was well tolerated and highly immunogenic in subjects ≥ 6 months of age. Taylor & Francis 2017-02-14 /pmc/articles/PMC5489275/ /pubmed/28301266 http://dx.doi.org/10.1080/21645515.2017.1285475 Text en © 2017 The Author(s). Published with license by Taylor & Francis http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.
spellingShingle Research Papers
Mo, Zhaojun
Nong, Yi
Liu, Shuzhen
Shao, Ming
Liao, Xueyan
Go, Kerry
Lavis, Nathalie
Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title_full Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title_fullStr Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title_full_unstemmed Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title_short Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China
title_sort immunogenicity and safety of a trivalent inactivated influenza vaccine produced in shenzhen, china
topic Research Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489275/
https://www.ncbi.nlm.nih.gov/pubmed/28301266
http://dx.doi.org/10.1080/21645515.2017.1285475
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