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  • Title: Investigation of an increase in large local reactions following vaccine schedule change to include DTaP-HB-IPV-Hib (Infanrix-hexa®) and MMRV (ProQuad®) at 18 months of age.
    Author: Kiely M, Billard MN, Toth E, Zafack JG, Landry M, Skowronski DM, De Serres G.
    Journal: Vaccine; 2018 Oct 29; 36(45):6688-6694. PubMed ID: 30269915.
    Abstract:
    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®, GSK) and quadrivalent measles-mumps-rubella-varicella vaccine (MMRV, ProQuad®, 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 23 months 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 ≥ 4 days. Among the 39 cases who were immunized in different limbs, 77% of the large local reactions were located at the Infanrix-hexa® site, 5% at the DTaP-IPV-Hib site and 18% at the ProQuad® site. Large local reactions were significantly more frequent with Infanrix-hexa® than with DTaP-IPV-Hib vaccine (OR 5.9 95% CI: 1.4-25.7). Administration of ProQuad® and Infanrix-hexa® 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® vaccine and that the risk was not greater when ProQuad® and Infanrix-hexa® 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® with informed parental consent.
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