title: Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.
abstract: Rotavirus is the most common cause of severe gastroenteritis in children under 5 y of age. Estimates of disease burden in Japan suggest that between 26,500 and 78,000 children in this age group need hospitalization each year, resulting in a direct medical cost of 10 to 24 billion Yen. Since being introduced in routine infant immunization schedules in the United States in 2006, the oral live pentavalent rotavirus vaccine RV5 (RotaTeq™) has contributed to dramatic reductions in the incidence of rotavirus gastroenteritis (RVGE) and in health care resource utilization. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of a 3-dose regimen of RV5 in healthy infants, age 6 to 12 weeks, at 32 sites across Japan. The results indicate that RV5 was significantly efficacious in preventing any severity [74.5% (95% confidence interval [CI]: 39.9%, 90.6%; p<0.001)], moderate-to-severe [80.2% (95% CI: 47.4%, 94.1%)], and severe [100% (95% CI: 55.4%, 100%)] RVGE caused by viruses with serotypes contained in the vaccine. The observed cases of RVGE included rotavirus types G1 (n=19), G3 (n=9), G9 (n=5) and one unspecified G serotype with P1A[8]. No G2 or G4 RVGE cases were observed, and this study was not powered to evaluate efficacy against individual serotypes. RV5 was generally safe and well tolerated in Japanese infants. These results are comparable to those observed in clinical studies conducted in other developed countries. Introduction of the vaccine in Japan may reduce disease burden and associated health care costs.
authors.affiliation: Center for Infectious Diseases and Infection Control; Keio University School of Medicine; Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iwata
authors.forename: Shuji
authors.initials: S
authors.lastname: Nakata
authors.forename: Susumu
authors.initials: S
authors.lastname: Ukae
authors.forename: Yoshitugu
authors.initials: Y
authors.lastname: Koizumi
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Morita
authors.forename: Haruo
authors.initials: H
authors.lastname: Kuroki
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Shizuya
authors.forename: Florian
authors.initials: F
authors.lastname: Schödel
authors.forename: Michelle L
authors.initials: ML
authors.lastname: Brown
authors.forename: Jody
authors.initials: J
authors.lastname: Lawrence
mesh_terms: D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D007223:Infant; D007564:Japan / Q000453:epidemiology; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D012400:Rotavirus Infections / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D012720:Severity of Illness Index; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D010919:Placebos; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: RV5; RVGE; pentavalent rotavirus vaccine; rotavirus gastroenteritis; vaccine