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. Issue 45 (29th October 2018)

• Record Type: Journal Article
• Authors: Kiely, Marilou; Billard, Marie-Noëlle; Toth, Eveline; Zafack, Joseline G.; Landry, Monique; Skowronski, Danuta M.; De Serres, Gaston
• Is Part Of: Vaccine. Volume 36:Issue 45(2018)
• Page Start: 6688
• Page End: 6694
• Publication Date: 2018-10-29
• Subjects: AEFI adverse event following immunization -- DTaP-IPV diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated polio vaccine, regardless of brand -- DTaP-IPV-Hib diphtheria toxoid, tetanus toxoid, acellular pertussis, inactivated polio and Haemophilus influenzae type b vaccine, regardless of brand -- DTaP-HB-IPV-Hib diphtheria toxoid, tetanus toxoid, acellular pertussis, Hepatitis B, inactivated polio and Haemophilus influenzae type b vaccine, regardless of brand -- Infanrix-IPV-Hib® diphtheria toxoid, tetanus toxoid, acellular pertussis, inactivated polio and Haemophilus influenzae type b vaccine manufactured by GlaxoSmithKline -- Infanrix-hexa® diphtheria toxoid, tetanus toxoid, acellular pertussis, HB, inactivated polio and Haemophilus influenzae type b vaccine manufactured by GlaxoSmithKline -- LLR large local reactions -- MMR measles, mumps and rubella vaccine, regardless of brand -- MMRV measles, mumps, rubella and varicella vaccine, regardless of brand -- ProQuad® measles, mumps, rubella and varicella vaccine manufactured by Merck -- Priorix-Tetra® measles, mumps, rubella and varicella vaccine manufactured by GlaxoSmithKline -- SI-PMI Quebec immunization registry -- QVAERS Quebec's vaccine adverse event reporting system; Adverse events -- Infanrix hexa -- ProQuad -- Large local reactions -- Childhood -- Booster dose; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2018.09.049
• Languages: English
• ISSNs: 0264-410X

Abstract

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.