https://scholars.lib.ntu.edu.tw/handle/123456789/525552
標題: | Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth | 作者: | CHUN-YI LU LUAN-YIN CHANG PEI-LAN SHAO Suryakiran P.V. Han H.-H. LI-MIN HUANG |
公開日期: | 2013 | 卷: | 112 | 期: | 9 | 起(迄)頁: | 574-577 | 來源出版物: | Journal of the Formosan Medical Association | 摘要: | 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. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84884703407&doi=10.1016%2fj.jfma.2012.11.016&partnerID=40&md5=9734266d0f882b25f78ba1ab17a1ca18 https://scholars.lib.ntu.edu.tw/handle/123456789/525552 |
ISSN: | 0929-6646 | DOI: | 10.1016/j.jfma.2012.11.016 | SDG/關鍵字: | 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 |
顯示於: | 醫學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。