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Papers of the Week

2021 Mar 04

Expert Rev Vaccines

Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines.


Mukherjee P, Akpo E I H, Kuznetsova A, Knuf M, Silfverdal S-A, Kosalaraksa P, Mihalyi A
Expert Rev Vaccines. 2021 Mar 04.
PMID: 33660582.


: The hexavalent vaccine DT3aP-HBV-IPV-Hib (Infanrix hexa, GSK) was first licensed in Europe in 2000. DT2aP-HBV-IPV-Hib (Hexyon/Hexacima/Hexaxim, Sanofi Pasteur), and DT5aP-HBV-IPV-Hib (Vaxelis, MCM Vaccine Company) were licensed in the EU in 2013 and 2016 respectively, based largely on studies demonstrating non-inferiority to DT3aP-HBV-IPV-Hib for immunogenicity and comparable reactogenicity profiles.: We conducted a systematic literature review looking for direct head-to-head trials comparing DT2aP-HBV-IPV-Hib and DT5aP-HBV-IPV-Hib with DT3aP-HBV-IPV-Hib. The incidence of solicited local and systemic reactions following primary series administration of DT3aP-HBV-IPV-Hib or DT2aP-HBV-IPV-Hib were meta-analyzed.: A total of 317 unique records were retrieved from the search; nine met the predefined inclusion criteria; seven reported studies comparing DT3aP-HBV-IPV-Hib and DT2aP-HBV-IPV-Hib. Six trials assessing outcomes of the primary vaccination series were identified. Odds ratios and 95% confidence intervals (OR; 95%CI) were computed for DT3aP-HBV-IPV-Hib, using DT2aP-HBV-IPV-Hib as reference, for redness (0.72; 0.63-0.83), pain (0.74; 0.62-0.89), swelling (0.86; 0.74-0.99) at injection site, fever (0.67; 0.54-0.83), persistent crying (0.72; 0.61-0.84), drowsiness (0.82; 0.71-0.94), irritability (0.82; 0.69-0.98), anorexia (0.83; 0.72-0.95), and vomiting (0.96; 0.83-1.11).: ORs of analyzed local and systemic solicited adverse reactions after primary vaccination with DT3aP-HBV-IPV-Hib appear to be slightly lower than with DT2aP-HBV-IPV-Hib.