Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study

Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: A randomized, double-blind, placebo-controlled, phase IV study

“…18,22,23 In a large multinational study conducted in Latin America and Finland, it was well established that RIX4414 vaccine was highly immunogenic, safe and efficacious when administered to healthy infants. 13,16,21 The efficacy of RIX4414 vaccine reached up to 85% (as compared with placebo, p < 0.001) against severe RV GE and RV-associated hospitalization and up to 100% against more severe RV GE in Latin American countries. 16 These data were pivotal in registration of Rotarix TM worldwide.…”

“…These results were in agreement with the observations made in the pre-licensure study conducted in similar settings 20 and other earlier studies conducted in other regions. 13,16 Although episodes of GE were HRV-068: HRV vaccine group in the present post-licensure study (NcT00969228); HRV-023: HRV vaccine group in the comparator study (NcT00140673); %: percentage of infants with anti-RV Iga concentration ≥ 20 U/mL; 95% cI: 95% standardised asymptotic confidence interval; LL: lower limit, UL: upper limit; *: criterion for non-inferiority: difference in the lower limit of the two-sided asymptotic standardized 95% cI for seroconversion rates between current post-licensure study in Korea and the comparator study in Latin america and Finland was ≥ -20%.…”

“…Jung soo Kim, 1 chong-Woo Bae, 2 Kyung-Yil Lee, 3 Moon sung park, 4 Young Youn choi, 5 Kwang-Nam Kim, 6 Jong Duck Kim,7 Won-soon park, 8 Jong-Beom sin, 9 ellen ai-Rhan Kim, 10 sang-Geel Lee, 11 chun soo Kim,12 sung-Ho cha, 13 Young Jin Hong, 14, * son-Moon shin, 15 Gyu-Hong shim, 16 Kyong Min choi,…”

“…[13][14][15][16][17][18][19] A pre-licensure study was conducted in Korea to assess the immunogenicity and safety of RIX4414 vaccine. The immunogenicity results of the pre-licensure study indicated that two doses of RIX4414 were immunogenic (seroconversion rate: 66.7%) when administered to healthy Korean infants.…”

Molecular characterization of rotaviruses in mid-western Turkey, 2006–2007

“…Thus far, at least 11 G types and 12 P types have been reported in humans. Of these, only 5 G types (G1 to G4, and G9) and 3 P types (P [4], P [6] and P [8]) mainly in six combinations (G1P [8], G2P [4], G3P [8], G4P [8], G9P [6] and G9P [8]) have been identified in >90% of rotavirusassociated hospitalizations [4,5].…”