2004
DOI: 10.1016/j.vaccine.2004.01.044
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Safety and immunogenicity of RIX4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants

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Cited by 130 publications
(81 citation statements)
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“…RV1 vaccinederived virus has a lower ID 50 (∼10 5 PFU/mL or less) that may present a higher chance of viral transmission. 17 Transmission of rotavirus vaccine strain RV1 to unvaccinated individuals has been assessed in many studies [18][19][20][21][22][23][24][25] but only documented as occurring in 3. [18][19][20] In studies documenting RV1 transmission, seroconversion varied from 2% to 6% among placebo recipients.…”
Section: Discussionmentioning
confidence: 99%
“…RV1 vaccinederived virus has a lower ID 50 (∼10 5 PFU/mL or less) that may present a higher chance of viral transmission. 17 Transmission of rotavirus vaccine strain RV1 to unvaccinated individuals has been assessed in many studies [18][19][20][21][22][23][24][25] but only documented as occurring in 3. [18][19][20] In studies documenting RV1 transmission, seroconversion varied from 2% to 6% among placebo recipients.…”
Section: Discussionmentioning
confidence: 99%
“…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,…”
Section: Immunogenicity Reactogenicity and Safety Of A Human Rotavirmentioning
confidence: 99%
“…[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.…”
Section: Immunogenicity Reactogenicity and Safety Of A Human Rotavirmentioning
confidence: 99%
“…6,8,18 For RV1, no difference versus placebo was observed in the incidence of diarrhea, fever or severe fever, vomiting or severe vomiting, and irritability or severe irritability within 14 days of immunization with any dose. 9,10,13,15 There was no statistically significant increased risk for death or other serious adverse events noted with either vaccine compared with placebo. Human strain 89-12 Composition Five human-bovine reassortant strains Single human strain RIX4414 G and P types G1P͓5͔ G1P͓8͔ G2P͓5͔ G3P͓5͔ G4P͓5͔ G6P͓8͔ Labeled indication Immunization against rotavirus gastroenteritis caused by G1, G2, G3, and G4 Immunization against rotavirus gastroenteritis caused by G1, G3, G4, and G9 Labeled age of administration, wk 6 through 32 11 Although neither RV5 nor RV1 has been associated with intussusception in large prelicensure trials, rigorous postlicensure monitoring for safety end points is necessary because of possible differences in the characteristics of infants receiving the vaccine in routine use compared with the clinical trials and the large numbers of infants being immunized.…”
Section: Reactogenicitymentioning
confidence: 87%