| アブストラクト | CONTEXT: In 2015 in Quebec, Canada, the passive vaccine adverse event reporting system detected an increase in large local reactions associated with vaccines recommended at the 18-month visit. This followed changes to the pediatric vaccine schedule to include hexavalent diphtheria-tetanus-acellular-pertusis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine (DTaP-IPV-Hib-HB, Infanrix-hexa(R), GSK) and quadrivalent measles-mumps-rubella-varicella vaccine (MMRV, ProQuad(R), Merck) as 18-month booster doses. OBJECTIVES: To determine if the excess of large local reactions was caused by a specific vaccine or their co-administration in the same limb or during the same visit. METHODS: A case-control study was conducted among cases born between January 2012 and April 2015 with a large local reaction following MMR+/-V or DTaP-IPV-Hib+/-HB vaccines administered between 16 and 23months of age. Controls were randomly selected from the provincial medicare database among children born during the same period. RESULTS: Our analysis included 96 cases and 494 controls vaccinated with MMRV or DTaP-IPV-Hib+/-HB vaccines. Among the 96 cases, 46% had a cellulitis and 54% had an injection site reaction extending beyond the nearest joint and/or lasting>/=4days. Among the 39 cases who were immunized in different limbs, 77% of the large local reactions were located at the Infanrix-hexa(R) site, 5% at the DTaP-IPV-Hib site and 18% at the ProQuad(R) site. Large local reactions were significantly more frequent with Infanrix-hexa(R) than with DTaP-IPV-Hib vaccine (OR 5.9 95% CI: 1.4-25.7). Administration of ProQuad(R) and Infanrix-hexa(R) in the same limb did not increase the risk of large local reactions. CONCLUSION: This investigation suggested that most large local reactions were causally associated with the Infanrix-hexa(R) vaccine and that the risk was not greater when ProQuad(R) and Infanrix-hexa(R) were administered in the same limb. Given the improved vaccine coverage for hepatitis B, benefit-risk analysis likely still favours ongoing use of Infanrix-hexa(R) with informed parental consent. |
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| ジャーナル名 | Vaccine |
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| 投稿日 | 2018/10/3 |
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| 投稿者 | Kiely, Marilou; Billard, Marie-Noelle; Toth, Eveline; Zafack, Joseline G; Landry, Monique; Skowronski, Danuta M; De Serres, Gaston |
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| 組織名 | Institut national de sante publique du Quebec, Quebec, Canada; Universite Laval,;Departement de medecine sociale et preventive, Quebec, Canada. Electronic;address: marilou.kiely@inspq.qc.ca.;CHU de Quebec Research Center, Laval University, Quebec, Canada. Electronic;address: marie-noelle.billard.ciussscn@ssss.gouv.qc.ca.;Ministere de la Sante et des Services sociaux, Quebec, Canada. Electronic;address: Eveline.Toth@msss.gouv.qc.ca.;Universite Laval, Departement de medecine sociale et preventive, Quebec, Canada.;Electronic address: joseline.zafack.ciussscn@ssss.gouv.qc.ca.;address: monique.landry@msss.gouv.qc.ca.;British Columbia Center for Disease Control, Vancouver, British Columbia, Canada.;Electronic address: Danuta.Skowronski@bccdc.ca.;Departement de medecine sociale et preventive, Quebec, Canada; CHU de Quebec;Research Center, Laval University, Quebec, Canada. Electronic address:;gaston.deserres@inspq.qc.ca. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30269915/ |
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