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Updated: May 21, 2026
Assays for the Specific Growth Rate and Cell-binding Ability of Rotavirus
Published on: January 28, 2019
Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized,
Jung Soo Kim1, Chong-Woo Bae, Kyung-Yil Lee
1ChonBuk National University Hospital, Jeonju, Jeollabuk-do, South Korea.
Insights
The rotavirus (RV) vaccine RIX4414 demonstrated strong immunogenicity in Korean infants, with high antibody response rates. The vaccine showed a safety profile comparable to placebo, indicating its suitability for young children.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Rotavirus (RV) infection is a leading cause of childhood gastroenteritis globally, particularly in children under five in Korea.
- Post-licensure studies are crucial for evaluating vaccine efficacy and safety in specific populations.
Purpose of the Study:
- To assess the immunogenicity and safety of the rotavirus vaccine RIX4414 in healthy Korean infants.
- To provide local clinical data to the Korean Food and Drug Association.
Main Methods:
- A post-licensure study involving healthy infants aged 6-12 weeks receiving two doses of RIX4414 or placebo.
- Serum anti-RV IgA antibody concentrations were measured using ELISA before dose 1 and one month post-dose 2.
- Gastroenteritis stool samples were tested for RV presence and G/P typing.
Main Results:
- The RIX4414 group achieved an 88.1% anti-RV IgA antibody seroconversion rate.
- Geometric mean concentration of anti-RV IgA antibodies was 208.5 U/ml in the RIX4414 group.
- Adverse event occurrence and RV detection in stool samples were similar between RIX4414 and placebo groups.
Conclusions:
- The two-dose RIX4414 regimen is immunogenic in healthy Korean infants.
- RIX4414 exhibits a safety profile similar to placebo in this population.
- The study supports the use of RIX4414 for rotavirus prevention in Korean infants.
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.
