https://scholars.lib.ntu.edu.tw/handle/123456789/566482
Title: | Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: A randomized clinical trial in an Asian population | Authors: | Phua K.B. Lim F.S. Lau Y.L. Nelson E.A.S. LI-MIN HUANG Quak S.H. Lee B.W. Doorn L.J.V. Teoh Y.L. Tang H. Suryakiran P.V. Smolenov I.V. Bock H.L. Han H.H. |
Keywords: | 3years; Efficacy; Gastroenteritis; RIX4414; Rotavirus | Issue Date: | 2012 | Journal Volume: | 30 | Journal Issue: | 30 | Start page/Pages: | 4552-4557 | Source: | Vaccine | Abstract: | RIX4414 (Rotarix?), has shown high efficacy during the first 2-years of life. A 2-year randomized, double-blind, placebo-controlled trial in Singapore, Hong Kong, and Taiwan was extended for another year. Infants (6-17. weeks) received 2-doses (1-2. months apart) of RIX4414 (n= 5359) or placebo (n= 5349). During the third-year follow-up, 4359 (RIX4414) and 4328 (placebo) infants were monitored. 64 (1.2%) and 2 (0.04%) infants in the placebo and RIX4414 groups, respectively, reported severe rotavirus-gastroenteritis (RVGE), resulting in a vaccine efficacy of 96.9% (95% CI [88.3-99.6]). Efficacy was 100% (67.5-100) in the third-year. RIX4414 was efficacious against G1 (100.0% [84.8-100]) and pooled non-G1 RV types (94.9% [80.2-99.4]). This study shows that the vaccine is highly efficacious, regardless of circulating RV-types, up to the first 3. years of life in affluent Asian urban populations. ? 2012 Elsevier Ltd. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84862020627&doi=10.1016%2fj.vaccine.2012.03.030&partnerID=40&md5=fd5900759c5d4c4d8ff88404458d120f https://scholars.lib.ntu.edu.tw/handle/123456789/566482 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2012.03.030 | SDG/Keyword: | Rotavirus vaccine; article; child; controlled study; double blind procedure; drug efficacy; drug safety; evaluation and follow up; gastroenteritis; Hong Kong; human; immunization; infant; phase 3 clinical trial; priority journal; randomized controlled trial; Singapore; Taiwan; unspecified side effect; urban population; virus strain; Asian Continental Ancestry Group; Child, Preschool; Double-Blind Method; Female; Gastroenteritis; Hong Kong; Humans; Infant; Male; Rotavirus Infections; Rotavirus Vaccines; Singapore; Taiwan; Vaccines, Attenuated |
Appears in Collections: | 醫學系 |
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