Trial reportHuman vaccines & immunotherapeutics2013
Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.
Trial report in Human vaccines & immunotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00718237 (A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
Who cites it
22 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants: A Systematic Review and Meta-analysis.JAMA network open · 2019Pooled it
- Efficacy of live oral rotavirus vaccines by duration of follow-up: a meta-regression of randomised controlled trials.The Lancet. Infectious diseases · 2019Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Safety and immunogenicity of a novel oral hexavalent rotavirus vaccine：a phase I clinical trial.Human vaccines & immunotherapeutics · 2021Trial
- Immunogenicity and safety of the diphtheria, pertussis, tetanus and inactivated poliovirus vaccine when co-administered with the human rotavirus vaccine (Rotarix) in healthy Japanese infants: a phase IV randomized study.Human vaccines & immunotherapeutics · 2019Trial
- Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries.Epidemiology and infection · 2018Trial
- Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants.Human vaccines & immunotherapeutics · 2017Trial
- Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST).Human vaccines & immunotherapeutics · 2014Trial
- Efficacy of rotavirus vaccines in Indonesia: A review of genotype distribution and impact.Narra J · 2025Review
- Global estimates of rotavirus vaccine efficacy and effectiveness: a rapid review and meta-regression analysis.EClinicalMedicine · 2025Article
- Effectiveness of self-financed rotavirus vaccination in Ise City, Japan.Human vaccines & immunotherapeutics · 2021Article
- Force of infection: a determinant of vaccine efficacy?NPJ vaccines · 2021Review
- The performance of licensed rotavirus vaccines and the development of a new generation of rotavirus vaccines: a review.Human vaccines & immunotherapeutics · 2021Review
- Case-Control Study of Rotavirus Vaccine Effectiveness Compared to Test-Negative Controls or Hospital Controls.Journal of epidemiology · 2019Article
- Therapeutics and Immunoprophylaxis Against Noroviruses and Rotaviruses: The Past, Present, and Future.Current drug metabolism · 2018Review
- Effectiveness of rotavirus vaccines against hospitalisations in Japan.BMC pediatrics · 2017Article
- Economic evaluation of routine infant rotavirus immunisation program in Japan.Human vaccines & immunotherapeutics · 2017Article
- Estimating rotavirus vaccine effectiveness in Japan using a screening method.Human vaccines & immunotherapeutics · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.