Efficacy and safety of pentavalent rotavirus vaccine in Japan: A randomized, double-blind, placebo-controlled, multicenter trial

Satoshi Iwata, Shuji Nakata, Susumu Ukae, Yoshitugu Koizumi, Yasuyuki Morita, Haruo Kuroki, Yoshiyuki Tanaka, Toshiyuki Shizuya, Florian Schödel, Michelle L. Brown, Jody Lawrence

Research output: Contribution to journalArticle

26 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1626-1633
Number of pages8
JournalHuman Vaccines and Immunotherapeutics
Volume9
Issue number8
DOIs
Publication statusPublished - 2013 Aug

Fingerprint

Rotavirus Vaccines
Rotavirus
Gastroenteritis
Multicenter Studies
Japan
Placebos
Safety
Confidence Intervals
Vaccines
Hospitalization Insurance
Patient Acceptance of Health Care
Immunization Schedule
Health Resources
Developed Countries
Health Care Costs
Age Groups
Viruses
Costs and Cost Analysis
Incidence
Serogroup

Keywords

  • Pentavalent rotavirus vaccine
  • Rotavirus gastroenteritis
  • RV5
  • RVGE
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Efficacy and safety of pentavalent rotavirus vaccine in Japan : A randomized, double-blind, placebo-controlled, multicenter trial. / Iwata, Satoshi; Nakata, Shuji; Ukae, Susumu; Koizumi, Yoshitugu; Morita, Yasuyuki; Kuroki, Haruo; Tanaka, Yoshiyuki; Shizuya, Toshiyuki; Schödel, Florian; Brown, Michelle L.; Lawrence, Jody.

In: Human Vaccines and Immunotherapeutics, Vol. 9, No. 8, 08.2013, p. 1626-1633.

Research output: Contribution to journalArticle

Iwata, S, Nakata, S, Ukae, S, Koizumi, Y, Morita, Y, Kuroki, H, Tanaka, Y, Shizuya, T, Schödel, F, Brown, ML & Lawrence, J 2013, 'Efficacy and safety of pentavalent rotavirus vaccine in Japan: A randomized, double-blind, placebo-controlled, multicenter trial', Human Vaccines and Immunotherapeutics, vol. 9, no. 8, pp. 1626-1633. https://doi.org/10.4161/hv.24846
Iwata, Satoshi ; Nakata, Shuji ; Ukae, Susumu ; Koizumi, Yoshitugu ; Morita, Yasuyuki ; Kuroki, Haruo ; Tanaka, Yoshiyuki ; Shizuya, Toshiyuki ; Schödel, Florian ; Brown, Michelle L. ; Lawrence, Jody. / Efficacy and safety of pentavalent rotavirus vaccine in Japan : A randomized, double-blind, placebo-controlled, multicenter trial. In: Human Vaccines and Immunotherapeutics. 2013 ; Vol. 9, No. 8. pp. 1626-1633.
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