A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I) Effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F14%3A10283196" target="_blank" >RIV/00179906:_____/14:10283196 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11150/14:10283196

Výsledek na webu

<a href="http://dx.doi.org/10.4161/hv.28666" target="_blank" >http://dx.doi.org/10.4161/hv.28666</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.4161/hv.28666" target="_blank" >10.4161/hv.28666</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I) Effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB

Popis výsledku v původním jazyce

The novel meningococcal serogroup B vaccine (4CMenB, Bexsero (R)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability,we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and12 months of age concomitantly with routine infant vaccines: DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol; a third group received MenC vaccine. Immune responses to 4CMenB were not decreased by the use of paracetamol

Název v anglickém jazyce

A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I) Effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB

Popis výsledku anglicky

The novel meningococcal serogroup B vaccine (4CMenB, Bexsero (R)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability,we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and12 months of age concomitantly with routine infant vaccines: DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol; a third group received MenC vaccine. Immune responses to 4CMenB were not decreased by the use of paracetamol

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

EC - Imunologie

OECD FORD obor

—

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

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

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

12

Strana od-do

1993-2004

Kód UT WoS článku

000342901200035

EID výsledku v databázi Scopus

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