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Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.
Hum Vaccin Immunother. 2013 Aug; 9(8):1626-33.HV

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+Show Affiliations

Center for Infectious Diseases and Infection Control; Keio University School of Medicine; Tokyo, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23732903

Citation

Iwata, Satoshi, et al. "Efficacy and Safety of Pentavalent Rotavirus Vaccine in Japan: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial." Human Vaccines & Immunotherapeutics, vol. 9, no. 8, 2013, pp. 1626-33.
Iwata S, Nakata S, Ukae S, et al. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013;9(8):1626-33.
Iwata, S., Nakata, S., Ukae, S., Koizumi, Y., Morita, Y., Kuroki, H., Tanaka, Y., Shizuya, T., Schödel, F., Brown, M. L., & Lawrence, J. (2013). Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Human Vaccines & Immunotherapeutics, 9(8), 1626-33. https://doi.org/10.4161/hv.24846
Iwata S, et al. Efficacy and Safety of Pentavalent Rotavirus Vaccine in Japan: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial. Hum Vaccin Immunother. 2013;9(8):1626-33. PubMed PMID: 23732903.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. AU - Iwata,Satoshi, AU - Nakata,Shuji, AU - Ukae,Susumu, AU - Koizumi,Yoshitugu, AU - Morita,Yasuyuki, AU - Kuroki,Haruo, AU - Tanaka,Yoshiyuki, AU - Shizuya,Toshiyuki, AU - Schödel,Florian, AU - Brown,Michelle L, AU - Lawrence,Jody, Y1 - 2013/05/31/ PY - 2013/6/5/entrez PY - 2013/6/5/pubmed PY - 2014/5/7/medline KW - RV5 KW - RVGE KW - pentavalent rotavirus vaccine KW - rotavirus gastroenteritis KW - vaccine SP - 1626 EP - 33 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 9 IS - 8 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/23732903/Efficacy_and_safety_of_pentavalent_rotavirus_vaccine_in_Japan:_a_randomized_double_blind_placebo_controlled_multicenter_trial_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.24846 DB - PRIME DP - Unbound Medicine ER -