Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10968851 | Vaccine | 2011 | 7 Pages |
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.
Keywords
MedDRAcell culture infective doseCCIDSAEGlaxoSmithKlineDTPAGMCGSKTVCRT-PCRATPEfficacyaccording-to-protocolEnzyme-linked immunosorbent assayELISAdiphtheria-tetanus-acellular pertussisMedical Dictionary for Regulatory Activitiesadverse eventSerious adverse eventconfidence intervalGeometric mean concentrationwild-typeHBVHepatitis B vaccineReverse transcriptase-polymerase chain reactionJapantotal vaccinated cohortRotavirus gastroenteritis
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Authors
Naohisa Kawamura, Yasunobu Tokoeda, Miho Oshima, Hiroyasu Okahata, Hiroyuki Tsutsumi, Leen Jan Van Doorn, Hisao Muto, Igor Smolenov, P.V. Suryakiran, Htay Htay Han,