Abstract:
: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.
journal_name
Hum Vaccin Immunotherjournal_title
Human vaccines & immunotherapeuticsauthors
Kim JS,Bae CW,Lee KY,Park MS,Choi YY,Kim KN,Kim JD,Park WS,Sin JB,Kim EA,Lee SG,Kim CS,Cha SH,Hong YJ,Shin SM,Shim GH,Choi KM,Yang JW,Liu A,Suryakiran PV,Han HHdoi
10.4161/hv.19853subject
Has Abstractpub_date
2012-06-01 00:00:00pages
806-12issue
6eissn
2164-5515issn
2164-554Xpii
19853journal_volume
8pub_type
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