Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan†
| Autor: | Hubert Buyse, Vincent Bauchau, Katsiaryna Holl, Lionel Van Holle, Keiji Sugiyama, Olivia Mahaux |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Pediatrics
medicine.medical_specialty pharmacoepidemiology Drug-Related Side Effects and Adverse Reactions Epidemiology Postmarketing surveillance Rotavirus vaccination Vaccines Attenuated Risk Assessment Rotarix TM Japan Intussusception (medical disorder) Original Reports medicine Product Surveillance Postmarketing Original Report Humans Pharmacology (medical) intussusception business.industry Incidence (epidemiology) Incidence Rotavirus Vaccines Pharmacoepidemiology medicine.disease Confidence interval Vaccination human rotavirus vaccine post‐marketing surveillance Risk assessment business |
| Zdroj: | Pharmacoepidemiology and Drug Safety |
| ISSN: | 1099-1557 1053-8569 |
| Popis: | Purpose RotarixTM was launched in November 2011 in Japan to prevent rotavirus gastroenteritis. Some studies suggest that RotarixTM may have a temporal association with a risk of intussusception (IS). We assessed a possible association between IS and RotarixTM vaccination in Japan. Methods All 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). Results Before January 2013, approximately 601 000 RotarixTM 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. Conclusion A 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. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. |
| Databáze: | OpenAIRE |
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