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
Identifikátory výsledku
Kód výsledku v 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>
Nalezeny alternativní kódy
RIV/00216208:11150/14:10283199
Výsledek na webu
<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>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
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
Popis výsledku v původním jazyce
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
Název v anglickém jazyce
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
Popis výsledku anglicky
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
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
EC - Imunologie
OECD FORD obor
—
Návaznosti výsledku
Projekt
—
Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2014
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Human Vaccines and Immunotherapeutics
ISSN
2164-5515
e-ISSN
—
Svazek periodika
10
Číslo periodika v rámci svazku
7
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
10
Strana od-do
2005-2014
Kód UT WoS článku
000342901200036
EID výsledku v databázi Scopus
—