| アブストラクト | OBJECTIVE: A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix. METHOD: all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the two vaccines. And the safety profile was compared to the safety data in the SPC. RESULTS: Comparison of relative AEFI reporting proportions in the global VigiBase database with VAERS for Gardasil and with RIVM for Cervarix shows a safety profile in VigiBase similar to the result of PMS on a national level in 2 countries. CONCLUSION: The post licensure safety profile of both vaccines is consistent with the data in the SPC of these vaccines. |
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| ジャーナル名 | The International journal of risk & safety in medicine |
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| 投稿日 | 2011/06/16 |
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| 投稿者 | Labadie, Jerry |
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| 組織名 | Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug;Monitoring, Uppsala, Sweden. jerry.labadie@who-umc.org |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/21673418/ |
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