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Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.
- Source :
-
Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2013 Aug; Vol. 9 (8), pp. 1626-33. Date of Electronic Publication: 2013 May 31. - Publication Year :
- 2013
-
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.
- Subjects :
- Double-Blind Method
Drug-Related Side Effects and Adverse Reactions epidemiology
Female
Gastroenteritis epidemiology
Gastroenteritis pathology
Humans
Incidence
Infant
Japan epidemiology
Male
Placebos administration & dosage
Rotavirus Infections epidemiology
Rotavirus Infections pathology
Rotavirus Vaccines administration & dosage
Severity of Illness Index
Vaccines, Attenuated administration & dosage
Vaccines, Attenuated adverse effects
Vaccines, Attenuated immunology
Gastroenteritis prevention & control
Rotavirus Infections prevention & control
Rotavirus Vaccines adverse effects
Rotavirus Vaccines immunology
Vaccination adverse effects
Vaccination methods
Subjects
Details
- Language :
- English
- ISSN :
- 2164-554X
- Volume :
- 9
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Human vaccines & immunotherapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 23732903
- Full Text :
- https://doi.org/10.4161/hv.24846