ArticlePharmacoepidemiology and drug safety2015
Post-marketing monitoring of intussusception after rotavirus vaccination in Japan.
Article in Pharmacoepidemiology and drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 citing papers in PubMed, 20 citations in OpenAlex.
- Trial
- A broad assessment of rotavirus vaccine safety in infants in Korea: Insights from a data-driven signal detection approach.Human vaccines & immunotherapeutics · 2025Article
- The Apparent Lack of the Risk of Intussusception Immediately After Rotavirus Vaccination Among Japanese Infants.Viruses · 2024Article
- Article
- Article
- A Pseudovirus Nanoparticle-Based Trivalent Rotavirus Vaccine Candidate Elicits High and Cross P Type Immune Response.Pharmaceutics · 2022Article
- Review
- Article
- A Nanoparticle-Based Trivalent Vaccine Targeting the Glycan Binding VP8* Domains of Rotaviruses.Viruses · 2021Article
- Retrospective multicenter matched case-control study on the risk factors for intussusception in infants less than 1 year of age with a special focus on rotavirus vaccines - the German Intussusception Study.Human vaccines & immunotherapeutics · 2020Article
- Immune response and protective efficacy of the S particle presented rotavirus VP8* vaccine in mice.Vaccine · 2019Article
- Incidence and epidemiology of intussusception among children under 2 years of age in Chenzhou and Kaifeng, China, 2009-2013.Vaccine · 2018Article
- Epidemiology of intussusception before and after rotavirus vaccine introduction in Fiji.Scientific reports · 2018Article
- Changes in the numbers of patients with acute gastroenteritis after voluntary introduction of the rotavirus vaccine in a Japanese children's primary emergency medical center.Environmental health and preventive medicine · 2017Article
- Development and evaluation of two subunit vaccine candidates containing antigens of hepatitis E virus, rotavirus, and astrovirus.Scientific reports · 2016Article
- Post-Marketing Benefit-Risk Assessment of Rotavirus Vaccination in Japan: A Simulation and Modelling Analysis.Drug safety · 2016Article
- Post-marketing monitoring of intussusception after rotavirus vaccination in Japan.Pharmacoepidemiology and drug safety · 2015Article
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Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRotarix(TM) was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that Rotarix(TM) may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and Rotarix(TM) vaccination in Japan.
methodsAll IS cases spontaneously reported post-vaccination (Brighton collaboration levels 1, 2, and 3) were extracted from the GlaxoSmithKline spontaneous report database on the 11th of January 2013. Expected numbers of IS cases were estimated using the number of vaccine doses distributed and the Japanese incidence rate of IS stratified by month of age. The observed versus expected analysis considered the IS cases for each risk period (7 and 30 days post-vaccination) and for each vaccine dose (two doses).
resultsBefore January 2013, approximately 601 000 Rotarix(TM) doses were distributed in Japan. For a risk period of 7 days post-dose 1 and post-dose 2, 10 and five IS cases were observed, whereas 3.4 and 7.6 were expected, providing an observed-to-expected ratio of 2.96 (95% confidence interval [CI]: 1.42; 5.45) and 0.66 (95% CI: 0.21; 1.53), respectively. For a risk period of 30 days post-dose 1 and post-dose 2, 14 and eight cases were observed, whereas 14.5 and 32.7 were expected, providing an observed-to-expected ratio of 0.97 (95% CI: 0.53; 1.62) and 0.24 (95% CI: 0.11; 0.48), respectively.
conclusionA statistically significant excess of IS cases was observed within 7 days post-dose 1, but not post-dose 2. These results are consistent with previous observations in large post-marketing safety studies in other world regions.
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