title: 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.
authors.affiliation: Osaka Rosai Hospital, Osaka, 1179-3 Nagasonecho, Kita-Ku, Sakai-City, Osaka, Japan. k-crimson@orh.go.jp
authors.forename: Naohisa
authors.initials: N
authors.lastname: Kawamura
authors.forename: Yasunobu
authors.initials: Y
authors.lastname: Tokoeda
authors.forename: Miho
authors.initials: M
authors.lastname: Oshima
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Okahata
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsutsumi
authors.forename: Leen Jan
authors.initials: LJ
authors.lastname: Van Doorn
authors.forename: Hisao
authors.initials: H
authors.lastname: Muto
authors.forename: Igor
authors.initials: I
authors.lastname: Smolenov
authors.forename: P V
authors.initials: PV
authors.lastname: Suryakiran
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007115:Immunization Schedule; D007564:Japan; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000276:immunology* / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated