Investigation of an increase in large local reactions following vaccine schedule change to include DTaP-HB-IPV-Hib (Infanrix-hexa(R)) and MMRV (ProQuad(R)) at 18months of age.
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.
|投稿者||Kiely, Marilou; Billard, Marie-Noelle; Toth, Eveline; Zafack, Joseline G; Landry, Monique; Skowronski, Danuta M; De Serres, Gaston|
|組織名||Institut national de sante publique du Quebec, Quebec, Canada; Universite Laval,;Departement de medecine sociale et preventive, Quebec, Canada. Electronic;address: firstname.lastname@example.org.;CHU de Quebec Research Center, Laval University, Quebec, Canada. Electronic;address: email@example.com.;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: firstname.lastname@example.org.;address: email@example.com.;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:;firstname.lastname@example.org.|