Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60162694%3AG44__%2F16%3A43875552" target="_blank" >RIV/60162694:G44__/16:43875552 - isvavai.cz</a>

Result on the web

<a href="http://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0546-5" target="_blank" >http://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0546-5</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s12887-016-0546-5" target="_blank" >10.1186/s12887-016-0546-5</a>

Result language

angličtina

Original language name

Varicella vaccine without human serum albumin versus licensed varicella vaccine in children during the second year of life: a randomized, double-blind, non-inferiority trial

Original language description

GSK's varicella vaccine contains HSA which is used to stabilize the virus and prevent immunogens from adhering to the injection vial walls. Because HSA is derived from human blood, there is a theoretical risk that it might contain infectious agents which could be unsafe for humans. Given this concern, a study was undertaken to compare the immunogenicity and safety of a new formulation without HSA with the currently licensed varicella vaccine in the CZ and Hungary. Healthy children aged 11-21 months received 2 doses of the varicella vaccine either with or without HSA. Antibody anti-VZV were measured 42 days after each dose, using an immunofluorescence assay and enzyme linked immunosorbent assay. Solicited local symptoms were recorded during a 4-day post-vaccination follow-up period; solicited general and unsolicited symptoms were recorded during a 43-day post-vaccination follow-up.Of 244 children, 233 (without HSA N=117; containing HSA N=116) formed the according-to-protocol immunogenicity cohort. Seroconversion/seroresponse rates were >98 and 100 %, 42 days after doses 1 and 2, respectively. The rates were within the same range in both groups, irrespective of the testing assay. The vaccine without HSA was non-inferior to the licensed vaccine in terms of anti-VZV antibody Geometric Mean Titre/Conc. ratio (1.12 [95 % CI:0.86-1.46] by IFA; 1.12 [95 % CI: 0.93-1.33] by ELISA) approximately 6x weeks after the 1st dose of the 2-dose vaccination course. The incidence of solicited and unsolicited symptoms was similar after both vaccines; low-grade fever was numerically higher after the 1st dose without HSA. Seven SAEs were reported, none of which were fatal or considered to be vaccine-related. The 1st dose of a new varicella vaccine without HSA was immunologically non-inferior to the licensed varicella vaccine. After 2 doses, both vaccines had acceptable safety profiles in children aged 11-21 months in the CZ and Hungary.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FN - Epidemiology, infection diseases and clinical immunology

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

BMC Pediatrics

ISSN

1471-2431

e-ISSN

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Volume of the periodical

16

Issue of the periodical within the volume

Jan

Country of publishing house

GB - UNITED KINGDOM

Number of pages

7

Pages from-to

"Article Number: 7"

UT code for WoS article

000368065600001

EID of the result in the Scopus database

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