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Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan

PURPOSE: Rotarix (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. METHODS:...

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Autores principales: Bauchau, Vincent, Van Holle, Lionel, Mahaux, Olivia, Holl, Katsiaryna, Sugiyama, Keiji, Buyse, Hubert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736691/
https://www.ncbi.nlm.nih.gov/pubmed/26013569
http://dx.doi.org/10.1002/pds.3800
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author Bauchau, Vincent
Van Holle, Lionel
Mahaux, Olivia
Holl, Katsiaryna
Sugiyama, Keiji
Buyse, Hubert
author_facet Bauchau, Vincent
Van Holle, Lionel
Mahaux, Olivia
Holl, Katsiaryna
Sugiyama, Keiji
Buyse, Hubert
author_sort Bauchau, Vincent
collection PubMed
description PURPOSE: Rotarix (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. 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 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. 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.
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spelling pubmed-47366912016-02-11 Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan Bauchau, Vincent Van Holle, Lionel Mahaux, Olivia Holl, Katsiaryna Sugiyama, Keiji Buyse, Hubert Pharmacoepidemiol Drug Saf Original Reports PURPOSE: Rotarix (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. 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 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. 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. John Wiley and Sons Inc. 2015-05-27 2015-07 /pmc/articles/PMC4736691/ /pubmed/26013569 http://dx.doi.org/10.1002/pds.3800 Text en © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Reports
Bauchau, Vincent
Van Holle, Lionel
Mahaux, Olivia
Holl, Katsiaryna
Sugiyama, Keiji
Buyse, Hubert
Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title_full Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title_fullStr Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title_full_unstemmed Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title_short Post‐marketing monitoring of intussusception after rotavirus vaccination in Japan
title_sort post‐marketing monitoring of intussusception after rotavirus vaccination in japan
topic Original Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736691/
https://www.ncbi.nlm.nih.gov/pubmed/26013569
http://dx.doi.org/10.1002/pds.3800
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