Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: A phase II randomized clinical trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F14%3A10218402" target="_blank" >RIV/00179906:_____/14:10218402 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00669806:_____/14:10218402

Výsledek na webu

<a href="http://www.sciencedirect.com/science/article/pii/S0264410X14004356#" target="_blank" >http://www.sciencedirect.com/science/article/pii/S0264410X14004356#</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.vaccine.2014.03.066" target="_blank" >10.1016/j.vaccine.2014.03.066</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: A phase II randomized clinical trial

Popis výsledku v původním jazyce

To provide broader protection against pneumococcal disease, new vaccines containing conserved Streptococcus pneumoniae proteins are being developed. This study assessed the safety, reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid and histidine triad protein in toddlers. In this phase II, multicenter, observer-blind conducted in the Czech Republic, toddlers (12-23 months) were randomized to receive one of four investigational vaccine or the licensed PHiD-CV, in a 2-dose primary series plus booster at study months 0, 2 and 6. Solicited local and general symptoms were recorded within seven days post-vaccination, unsolicited symptoms within 31 days post-vaccination, and serious adverse events (SAEs)during the entire study period. Antibody concentrations against the vaccine components were measured pre-vaccination, one month post-dose 2, pre- and one month post-booster.257 toddlers were enrolled and vaccinated. Percentages of solici

Název v anglickém jazyce

Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: A phase II randomized clinical trial

Popis výsledku anglicky

To provide broader protection against pneumococcal disease, new vaccines containing conserved Streptococcus pneumoniae proteins are being developed. This study assessed the safety, reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid and histidine triad protein in toddlers. In this phase II, multicenter, observer-blind conducted in the Czech Republic, toddlers (12-23 months) were randomized to receive one of four investigational vaccine or the licensed PHiD-CV, in a 2-dose primary series plus booster at study months 0, 2 and 6. Solicited local and general symptoms were recorded within seven days post-vaccination, unsolicited symptoms within 31 days post-vaccination, and serious adverse events (SAEs)during the entire study period. Antibody concentrations against the vaccine components were measured pre-vaccination, one month post-dose 2, pre- and one month post-booster.257 toddlers were enrolled and vaccinated. Percentages of solici

Druh

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

CEP obor

FN - Epidemiologie, infekční nemoci a klinická imunologie

OECD FORD obor

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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

Vaccine

ISSN

0264-410X

e-ISSN

—

Svazek periodika

32

Číslo periodika v rámci svazku

25

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

3025-3034

Kód UT WoS článku

000336713000017

EID výsledku v databázi Scopus

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