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Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines.
Mukherjee, Piyali; Akpo, Essè Ifèbi Hervé; Kuznetsova, Anastasia; Knuf, Markus; Silfverdal, Sven-Arne; Kosalaraksa, Pope; Mihalyi, Attila.
Afiliación
  • Mukherjee P; GSK, Wavre, Belgium.
  • Akpo EIH; GSK, Wavre, Belgium.
  • Kuznetsova A; GSK, Wavre, Belgium.
  • Knuf M; Children's Hospital, Helios Dr. Horst Schmidt Clinics, Wiesbaden, Germany.
  • Silfverdal SA; Pediatric Infectious Diseases, University Medicine, Mainz, Germany.
  • Kosalaraksa P; Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
  • Mihalyi A; Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Expert Rev Vaccines ; 20(3): 319-330, 2021 03.
Article en En | MEDLINE | ID: mdl-33660582
Introduction: 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.Methods: 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.Results: 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).Conclusion: 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna Antipolio de Virus Inactivados / Vacuna contra Difteria, Tétanos y Tos Ferina / Vacunación / Vacunas contra Hepatitis B / Vacunas contra Haemophilus / Vacunas contra Difteria, Tétanos y Tos Ferina Acelular Tipo de estudio: Etiology_studies / Prognostic_studies / Systematic_reviews Límite: Humans / Infant País/Región como asunto: Europa Idioma: En Revista: Expert Rev Vaccines Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacuna Antipolio de Virus Inactivados / Vacuna contra Difteria, Tétanos y Tos Ferina / Vacunación / Vacunas contra Hepatitis B / Vacunas contra Haemophilus / Vacunas contra Difteria, Tétanos y Tos Ferina Acelular Tipo de estudio: Etiology_studies / Prognostic_studies / Systematic_reviews Límite: Humans / Infant País/Región como asunto: Europa Idioma: En Revista: Expert Rev Vaccines Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Bélgica Pais de publicación: Reino Unido