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Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life.

Abstract：

:A phase III, randomized, double-blind study evaluated the efficacy, reactogenicity, safety and immunogenicity of a human rotavirus vaccine, RIX4414 in Japanese infants aged 6-14 weeks when administered as two doses (0, 1-month schedule). Efficacy against any and severe rotavirus gastroenteritis leading to medical intervention caused by circulating wild-type rotavirus from two weeks post-Dose 2 until two years of age was 79.3% (95% CI: 60.5-89.8%) and 91.6% (95% CI: 62.4-99.1%), respectively. Solicited, unsolicited symptoms and serious adverse events were reported at a similar frequency in both groups. Serum anti-rotavirus antibody seroconversion rate one-month post-Dose 2 was 85.3% (95% CI: 68.9-95%) in RIXX4414 group. RIX4414 was efficacious, well-tolerated and immunogenic in Japanese infants and introduction of vaccination could help in reducing the disease burden.

journal_name

Vaccine

journal_title

Vaccine

authors

Kawamura N,Tokoeda Y,Oshima M,Okahata H,Tsutsumi H,Van Doorn LJ,Muto H,Smolenov I,Suryakiran PV,Han HH

doi

10.1016/j.vaccine.2011.05.017

subject

Has Abstract

pub_date

2011-08-26 00:00:00

pages

6335-41

issue

37

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(11)00727-4

journal_volume

29

pub_type

杂志文章,多中心研究,随机对照试验

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