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

Result code in 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>

Alternative codes found

RIV/00669806:_____/14:10218402

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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

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

2014

Confidentiality

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

Name of the periodical

Vaccine

ISSN

0264-410X

e-ISSN

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Volume of the periodical

32

Issue of the periodical within the volume

25

Country of publishing house

GB - UNITED KINGDOM

Number of pages

10

Pages from-to

3025-3034

UT code for WoS article

000336713000017

EID of the result in the Scopus database

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