A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II) Effects of variations of the OMV and protein content on immunogenicity and reactogenicity
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F14%3A10283199" target="_blank" >RIV/00179906:_____/14:10283199 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11150/14:10283199
Result on the web
<a href="http://dx.doi.org/10.4161/hv.29218" target="_blank" >http://dx.doi.org/10.4161/hv.29218</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.4161/hv.29218" target="_blank" >10.4161/hv.29218</a>
Alternative languages
Result language
angličtina
Original language name
A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II) Effects of variations of the OMV and protein content on immunogenicity and reactogenicity
Original language description
The licensed meningococcal serogroup B vaccine, 4CMenB (Bexsero (R)), contains recombinant membrane proteins (rMenB) and outer membrane vesicles (OMV) of the New Zealand serogroup B strain. We investigated whether reducing the OMV and/or protein contentinfluences 4CMenB immunogenicity and reactogenicity in healthy two month-old infants. Six formulations were studied: 4CMenB, rMenB with 0, 1/4 or 1/2 the OMV dose in 4CMenB, a half-dose of 4CMenB or a prelicensure formulation of 4CMenB, as a 4-dose primary/booster series, concomitantly with routine vaccines (DTaP-HBV-IPV/Hib and 7-valent pneumococcal conjugate) at 2, 3, 4 and 12 months of age. Immunogenicity was assessed as serum bactericidal activity measured with human complement (hSBA) against indicator strains for Men B vaccine antigens before and after the 2,3,4-month series and 12-month dose. Parents recorded solicited reactions for 7 days after each vaccination, and any adverse events throughout the study period. All formulations
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
EC - Immunology
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Human Vaccines and Immunotherapeutics
ISSN
2164-5515
e-ISSN
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Volume of the periodical
10
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
2005-2014
UT code for WoS article
000342901200036
EID of the result in the Scopus database
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