|Title:||Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth||Authors:||CHUN-YI LU
|Issue Date:||2013||Journal Volume:||112||Journal Issue:||9||Start page/Pages:||574-577||Source:||Journal of the Formosan Medical Association||Abstract:||
This Phase-IV study evaluated the human rotavirus (RV) vaccine Rotarix (RIX4414) to provide additional local clinical data to the Taiwan Food and Drug Association (NCT01198769). Healthy infants aged 6-12 weeks who were given a hepatitis B immunoglobulin (HBIg) dose after birth, received two doses of RIX4414 (0, 2-month schedule). Anti-RV IgA antibody concentrations were measured using ELISA. A total of 15 infants were enrolled, and included in the according-to-protocol cohort. The anti-RV IgA antibody seroconversion rate 2 months post-Dose 2 was 100% (95% confidence interval=78.2-100) and the geometric mean concentration was 254.7U/ml (95% confidence interval=145.0-447.7). Two episodes of gastroenteritis were reported, and one stool sample was tested for RV, which was negative. No fatal serious adverse events were reported during the study period between November 2010 and April 2011. The two-dose regimen of RIX4414 was highly immunogenic and safe when administered to healthy Taiwanese infants who received a HBIg dose after birth.Trial registration number: NCT01198769. ? 2012.
|ISSN:||0929-6646||DOI:||10.1016/j.jfma.2012.11.016||SDG/Keyword:||hepatitis B antibody; immunoglobulin A antibody; Rotavirus vaccine; article; bronchiolitis; cohort analysis; coughing; diarrhea; drug safety; eczema; enzyme linked immunosorbent assay; feces analysis; female; fever; hepatitis B; human; human experiment; immunization; immunogenicity; infant; irritability; loss of appetite; male; normal human; phase 4 clinical trial; rhinorrhea; Rotavirus infection; seroconversion; side effect; Taiwan; unspecified side effect; vomiting; hepatitis B envelope antigen; hepatitis B immunoglobulin; hepatitis B surface antigen; rotavirus; Taiwan; Antibodies, Viral; Humans; Immunoglobulins; Infant; Rotavirus; Rotavirus Vaccines; Vaccines, Attenuated
|Appears in Collections:||醫學系|
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