Document Detail


Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study.
MedLine Citation:
PMID:  22699440     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 years of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Drug Association. Healthy infants aged 6-12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0, 1-2 month schedule. Blood samples were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA. Gastroenteritis stool samples were tested for the presence of RV using ELISA. RV positive samples were subjected to further analysis for G and P typing. Among 684 infants enrolled and vaccinated, 432 infants (RIX4414=318; placebo=114) were included in the according-to-protocol cohort for immunogenicity. The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1% (95% CI: 84.0-91.4) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml (95% CI: 174.2-249.5). Occurrence of solicited and unsolicited adverse events were similar in both, RIX4414 and placebo groups. None of the gastroenteritis stool samples tested positive for RV and no fatal SAEs were reported in either groups. The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared to the placebo group, when administered to healthy Korean infants.
Authors:
Jung Soo Kim; Chong-Woo Bae; Kyung-Yil Lee; Moon Sung Park; Young Youn Choi; Kwang-Nam Kim; Jong Duck Kim; Won-Soon Park; Jong-Beom Sin; Ellen Ai-Rhan Kim; Sang-Geel Lee; Chun Soo Kim; Sung-Ho Cha; Young Jin Hong; Son-Moon Shin; Gyu-Hong Shim; Kyong Min Choi; Jun Won Yang; Aixue Liu; P V Suryakiran; Htay Htay Han
Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-06-01
Journal Detail:
Title:  Human vaccines & immunotherapeutics     Volume:  8     ISSN:  2164-554X     ISO Abbreviation:  Hum Vaccin Immunother     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-07-06     Completed Date:  2013-01-17     Revised Date:  2014-10-09    
Medline Journal Info:
Nlm Unique ID:  101572652     Medline TA:  Hum Vaccin Immunother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  806-12     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Antibodies, Viral / immunology
Double-Blind Method
Enzyme-Linked Immunosorbent Assay
Female
Gastroenteritis / immunology
Humans
Immunoglobulin A / immunology
Infant
Male
Rotavirus Vaccines / adverse effects*,  immunology*,  therapeutic use
Vaccines, Attenuated / adverse effects,  immunology,  therapeutic use
Chemical
Reg. No./Substance:
0/Antibodies, Viral; 0/Immunoglobulin A; 0/RIX4414 vaccine; 0/Rotavirus Vaccines; 0/Vaccines, Attenuated

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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