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Review

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure

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Pages 1196-1213 | Received 20 Sep 2023, Accepted 02 Nov 2023, Published online: 06 Dec 2023

References

  • WHO. Pertussis vaccines: WHO position paper - September 2015. Weekly Epidemiological Rec. 2015 Aug 28;90(35):433–458.
  • WHO. Diphtheria vaccine: WHO position paper - August 2017. Weekly Epidemiological Rec. 2017 Aug 4;92(31):417–435.
  • WHO. Tetanus vaccines: WHO position paper - February 2017. Weekly Epidemiological Rec. 2017 Feb 10;92(6):53–76.
  • WHO. Polio vaccines: WHO position paper - June 2022. Weekly Epidemiological Rec. 2022;97:277–300.
  • WHO. Haemophilus influenzae type b (Hib) vaccination position paper. Weekly Epidemiological Rec. 2013 Jul 2013 Sep 27;88(39):413–426
  • WHO. Hepatitis B vaccines: WHO position paper – July 2017. Wkly Epidemiol Rec. 2017 Jul 7;92(27):369–392.
  • WHO. Hepatitis B. Accessed 2023 Oct 20. Available from: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-b
  • Huoi C, Vargas-Zambrano J, Macina D, et al. A combined DTaP-IPV vaccine (Tetraxim®/tetravac®) used as school-entry booster: a review of more than 20 years of clinical and post-marketing experience. Expert Rev Vaccines. 2022 Aug;22(9):1–17. doi: 10.1080/14760584.2022.2084076
  • Plotkin SA, Liese J, Madhi SA, et al. A DTaP-IPV//PRP~T vaccine (Pentaxim): a review of 16 years’ clinical experience. Expert Rev Vaccines. 2011 Jul;10(7):981–1005. doi: 10.1586/erv.11.72
  • Tregnaghi MW, Voelker R, Santos-Lima E, et al. Immunogenicity and safety of a novel yeast hansenula polymorpha-derived recombinant hepatitis B candidate vaccine in healthy adolescents and adults aged 10-45 years. Vaccine. 2010 Apr 30;28(20):3595–3601. doi: 10.1016/j.vaccine.2010.02.049
  • European Medicines Agency. Hexaxim: opinion on medicine for use outside EU. Accessed 2023 Oct 20. Available from: https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/hexaxim
  • European Medicines Agency. Hexacima. Accessed 2023 Oct 20. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/hexacima.
  • WHO. Prequalification of medical products (IVDs, medicines, vaccines and immunization devices, vector control): vaccines - Hexaxim. Available from: https://extranet.who.int/prequal/vaccines/p/hexaxim. Accessed 20 Oct 2023.
  • Lyseng-Williamson KM, McCormack PL. DTaP-IPV-Hep B-Hib vaccine (Hexyon®/hexacima®): a guide to its use in the primary and booster vaccination of infants and toddlers in Europe. Drugs Ther Perspect. 2013;29(11):329–335. doi: 10.1007/s40267-013-0078-0
  • McCormack PL. DTaP-IPV-Hep B-Hib vaccine (Hexaxim®): a review of its use in primary and booster vaccination. Paediatr Drugs. 2013 Feb;15(1):59–70. doi: 10.1007/s40272-013-0007-7
  • Syed YY. DTaP-IPV-HepB-Hib vaccine (Hexyon®): an updated review of its use in primary and booster vaccination. Paediatr Drugs. 2019 Oct;21(5):397–408. doi: 10.1007/s40272-019-00353-7.
  • Madhi SA, Mitha I, Cutland C, et al. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68–74. doi: 10.1097/INF.0b013e31820b93d2
  • Madhi SA, Koen A, Cutland C, et al. Antibody persistence and booster vaccination of a fully liquid hexavalent vaccine coadministered with measles/mumps/rubella and varicella vaccines at 15-18 months of age in healthy South African infants. Pediatr Infect Dis J. 2013 Aug;32(8):889–897. doi: 10.1097/INF.0b013e318292f7b1
  • Chhatwal J, Lalwani S, Vidor E. Immunogenicity and safety of a liquid hexavalent vaccine in Indian infants. Indian Pediatr. 2017;54(1):15–20. doi: 10.1007/s13312-017-0989-2
  • Ceyhan M, Yildirim, I., Tezer, H., Devrim, I., Feroldi, E. A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers. Turkish Journal of Medical Sciences. 2017;47:1247–1256.
  • Prymula R, Kieninger D, Feroldi E, et al. Immunogenicity and safety of primary and booster vaccinations of a fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine in healthy infants and toddlers in Germany and the Czech Republic. Pediatr Infect Dis J. 2018 Aug;37(8):823–830. doi: 10.1097/INF.0000000000002109
  • Vu D, Thuy T, Radigue C, et al. Immunogenicity and safety of fully liquid hexavalent vaccine given to Vietnamese infants previously vaccinated at birth with hepatitis B vaccine. Southeast Asian J Trop Med Public Health. 2019;50:1078–1089.
  • Vesikari T, Borrow R, Da Costa X, et al. Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants. Vaccine. 2017 Jan 11;35(3):452–458. doi: 10.1016/j.vaccine.2016.11.053
  • Vesikari T, Borrow R, Da Costa X, et al. Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers. Vaccine. 2018 Dec 18;36(52):8019–8027. doi: 10.1016/j.vaccine.2018.10.100
  • Macias M, Lanata CF, Zambrano B, et al. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126–32. doi: 10.1097/INF.0b013e318258400d
  • Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88–96. doi: 10.1097/INF.0b013e318212eb80
  • Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24–30. doi: 10.1097/INF.0b013e318242460a
  • Aquino AG, Brito MG, Doniz CE, et al. A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children. Vaccine. 2012 Oct 5;30(45):6492–6500. doi: 10.1016/j.vaccine.2012.07.040
  • Kosalaraksa P, Thisyakorn U, Benjaponpitak S, et al. Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants. Inter J Infect Dis. 2011 Apr;15(4):e249–56. doi: 10.1016/j.ijid.2010.12.004
  • Lanata C, Zambrano B, Ecker L, et al. Immunogenicity and safety of a fully liquid DTaP-IPV-Hep B-PRP-T vaccine at 2-4-6 months of age in Peru. J Vaccines Vaccin. 2012;3:128. doi: 10.4172/2157-7560.1000128
  • López P, Arguedas Mohs A, Abdelnour Vásquez A, et al. A randomized, controlled study of a fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccinations of healthy infants and toddlers in Latin America. Pediatr Infect Dis J. 2017;36(11):e272–e282.
  • Kim YK, Vidor E, Kim HM, et al. Immunogenicity and safety of a fully liquid DTaP-IPV-HB-PRP~T hexavalent vaccine compared with the standard of care in infants in the Republic of Korea. Vaccine. 2017 Jul 13;35(32):4022–4028. doi: 10.1016/j.vaccine.2017.05.062
  • Vesikari T, Silfverdal SA, Jordanov E, et al. A randomized, controlled study of DTaP-IPV-HB-PRP-T, a fully liquid hexavalent vaccine, administered in a 3, 5 and 11-12 month schedule. Pediatr Infect Dis J. 2017;36(1):87–93. doi: 10.1097/INF.0000000000001358
  • Martinon-Torres F, Diez-Domingo J, Feroldi E, et al. Evaluation of a hexavalent-pentavalent-hexavalent infant primary vaccination series followed by a pentavalent booster vaccine in healthy infants and toddlers. Pediatr Infect Dis J. 2019 Mar;38(3):317–322. doi: 10.1097/INF.0000000000002231
  • Madhi SA, Lopez P, Zambrano B, et al. Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration. Human Vaccines Immunother. 2019;15(3):658–668.
  • Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, et al. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP~T vaccination at 2, 4 and 6 months. Human Vaccines Immunother. 2018;14(5):1257–1265.
  • Virta M, Soininen A, Patel DM, et al. Persistence of hepatitis B immune memory until 6 years of age following hexavalent DTaP-IPV-HB-PRP~T vaccination in a 3-, 5- and 11- to 12-month schedule and response to a subsequent hepatitis B challenge vaccination. Pediatr Infect Dis J. 2021 Jan;40(1):e28–e30. doi: 10.1097/INF.0000000000002954
  • Edwards K, Decker M. Pertussis vaccines. In: Plotkin S, Orenstein W, Offit P, and Edwards K editors. Vaccines. 7th PA USA: Elsevier; 2018p. 711–761.
  • Le Saux N, Barrowman NJ, Moore DL, et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Pediatrics. 2003 Nov;112(5):e348. doi: 10.1542/peds.112.5.e348
  • DuVernoy TS, Braun MM. Hypotonic-hyporesponsive episodes reported to the vaccine adverse event reporting System (VAERS), 1996-1998. Pediatrics. 2000 Oct;106(4):E52. doi: 10.1542/peds.106.4.e52
  • Gold MS. Hypotonic-hyporesponsive episodes following pertussis vaccination: a cause for concern? Drug Saf. 2002;25(2):85–90. doi: 10.2165/00002018-200225020-00003
  • Mukherjee P, Akpo EIH, Kuznetsova A, et al. Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines. Expert Rev Vaccines. 2021 Mar;20(3):319–330. doi: 10.1080/14760584.2021.1892493
  • Martinelli D, Fortunato F, Del Matto G, et al. Post-marketing surveillance study of the DTaP2-IPV-HB-Hib (Hexyon) vaccine administered in preterm infants in the Apulia region, Italy, in 2017. Vaccine. 2020 Jul 14;38(33):5148–5153. doi: 10.1016/j.vaccine.2020.06.033
  • Maertens K, Orije MRP, Huoi C, et al. Immunogenicity of a liquid hexavalent DTaP-IPV-HB-PRP~T vaccine after primary and booster vaccination of term and preterm infants born to women vaccinated with Tdap during pregnancy. Vaccine. 2023 Jan 16;41(3):795–804. doi: 10.1016/j.vaccine.2022.12.021
  • Omenaca F, Vazquez L, Garcia-Corbeira P, et al. Immunization of preterm infants with GSK’s hexavalent combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine: a review of safety and immunogenicity. Vaccine. 2018 Feb 8;36(7):986–996. doi: 10.1016/j.vaccine.2018.01.005
  • Koen A, Madhi S, Lyabis O, et al. Immunogenicity and safety of a hexavalent pediatric vaccine in HIV-exposed infected and uninfected infants in Republic of South Africa. Human Vaccines Immunother. 2021 Dec 16;17(6):1770–1778. doi: 10.1080/21645515.2020.1839289
  • European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) (EMA/873138/2011 Rev 2). Accessed 2023 Oct 20. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf.
  • Jorch G, Tapiainen T, Bonhoeffer J, et al. Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5707–5716. doi: 10.1016/j.vaccine.2007.02.068
  • Mahaux O, Bauchau V, Van Holle L. Pharmacoepidemiological considerations in observed-to-expected analyses for vaccines. Pharmacoepidemiol Drug Saf. 2016 Feb;25(2):215–222. doi: 10.1002/pds.3918
  • Esposito S, Stefanelli P, Fry NK, et al. Pertussis prevention: reasons for resurgence, and differences in the current acellular pertussis vaccines. Front Immunol. 2019;10:1344. doi: 10.3389/fimmu.2019.01344
  • Simondon F, Preziosi MP, Yam A, et al. A randomized double-blind trial comparing a two-component acellular to a whole-cell pertussis vaccine in Senegal. Vaccine. 1997 Oct;15(15):1606–1612. doi: 10.1016/S0264-410X(97)00100-X
  • The Public Health Agency of Sweden. Pertussis surveillance in Sweden: 23rd annual report. Accessed 2023 Oct 20. Available from: https://www.folkhalsomyndigheten.se/contentassets/975cc036216b48a39b7bf34319d4ecee/pertussis-surveillance-sweden-23rd-annual-report.pdf.
  • Aronsson B, Källberg H, Byström E, et al. Vaccine effectiveness of acellular pertussis vaccine estimated by the screening method, Swedish preschool children, 2007-2018. 38th Annual Meeting, European Society for Paediatric Infectious Diseases (ESPID), Rotterdam, The Netherlands (virtual) 2020 Oct 26-29. Abstract #2613, p. 36. Available from: https://2023.espidmeeting.org/wp-content/uploads/sites/19/2022/06/ESDID-2020-Abstracts.pdf?_ga=2.181403168.627835425.1671011579-1449896900.1670334018. Accessed 20 Oct 2023.
  • Aquino-Andrade A, Martinez-Leyva G, Merida-Vieyra J, et al. Real-time polymerase chain reaction-based detection of bordetella pertussis in Mexican infants and their contacts: a 3-year multicenter study. J Paediatr. 2017 Sep;188:217–223 e1.
  • Sanchez-Gonzalez G, Luna-Casas G, Mascarenas C, et al. Pertussis in Mexico from 2000 to 2019: a real-world study of incidence, vaccination coverage, and vaccine effectiveness. Vaccine. 2023 Sep 1;41(41):6105–6111. doi: 10.1016/j.vaccine.2023.08.046
  • Mohamed TJ, Fong SM, Nadarajaw T, et al. Burden of pertussis among young infants in Malaysia: a hospital-based surveillance study. Vaccine. 2022 Aug 19;40(35):5241–5247. doi: 10.1016/j.vaccine.2022.07.019
  • Wood N, McIntyre P. Pertussis: review of epidemiology, diagnosis, management and prevention. Paediatr Respir Rev. 2008 Sep;9(3):201-11; quiz 211–2. doi: 10.1016/j.prrv.2008.05.010
  • Adams DA, Jajosky RA, Ajani U, et al. Summary of notifiable diseases–United States, 2012. Morbidity Mortality Weekly Rep. 2014 Sep 19;61(53):1–121. doi: 10.15585/mmwr.mm6253a1
  • Jajosky RA, Hall PA, Adams DA, et al. Summary of notifiable diseases–United States, 2004. Morb Mortal Weekly Rep. 2006 Jun 16;53(53):1–79.
  • McNabb SJ, Jajosky RA, Hall-Baker PA, et al. Summary of notifiable diseases — United States, 2005. Morbidity Mortality Weekly Rep. 2007 Mar 30;54(53):1–92.
  • McIntrye P, Gidding H, Gilmour R, et al. Vaccine preventable diseases and vaccination coverage in Australia, 1999 to 2000. Commun Dis Intell Q Rep. 2002 May;Suppl:1–111. PMID: 12194422.
  • Gentile A, Bricks L, Avila-Aguero ML, et al. Pertussis in Latin America and the Hispanic Caribbean: a systematic review. Expert Rev Vaccines. 2019 Aug;18(8):829–845. doi: 10.1080/14760584.2019.1643241
  • Avila-Aguero ML, Camacho-Badilla K, Ulloa-Gutierrez R, et al. Epidemiology of pertussis in Costa Rica and the impact of vaccination: a 58-year experience (1961-2018). Vaccine. 2022 Jan 21;40(2):223–228. doi: 10.1016/j.vaccine.2021.11.078
  • Carlsson RM, Trollfors B. Control of pertussis–lessons learnt from a 10-year surveillance programme in Sweden. Vaccine. 2009 Sep 25;27(42):5709–5718. doi: 10.1016/j.vaccine.2009.07.092.
  • Gustafsson L, Hessel L, Storsaeter J, et al. Long-term follow-up of Swedish children vaccinated with acellular pertussis vaccines at 3, 5, and 12 months of age indicates the need for a booster dose at 5 to 7 years of age. Pediatrics. 2006 Sep;118(3):978–984. doi: 10.1542/peds.2005-2746
  • Olin P, Hallander HO. Marked decline in pertussis followed reintroduction of pertussis vaccination in Sweden. Euro Surveillance. 1999 Dec;4(12):128–129. doi: 10.2807/esm.04.12.00084-en
  • Bisgard KM, Rhodes P, Connelly BL, et al. Pertussis vaccine effectiveness among children 6 to 59 months of age in the United States, 1998-2001. Pediatrics. 2005 Aug;116(2):e285–94. doi: 10.1542/peds.2004-2759
  • Liese JG, Meschievitz CK, Harzer E, et al. Efficacy of a two-component acellular pertussis vaccine in infants. Pediatr Infect Dis J. 1997 Nov;16(11):1038–1044. doi: 10.1097/00006454-199711000-00007
  • Okada K, Ohashi Y, Matsuo F, et al. Effectiveness of an acellular pertussis vaccine in Japanese children during a non-epidemic period: a matched case-control study. Epidemiol Infect. 2009 Jan;137(1):124–130. doi: 10.1017/S0950268808000708
  • O’Ryan M, Calvo AE, Espinoza M, et al. Parent reported outcomes to measure satisfaction, acceptability, and daily life impact after vaccination with whole-cell and acellular pertussis vaccine in Chile. Vaccine. 2020 Oct 7;38(43):6704–6713. doi: 10.1016/j.vaccine.2020.08.046
  • Romero M, Rodriguez D, Caicedo M, et al. Cost-minimization and budget impact analysis of a hexavalent vaccine (Hexaxim®The Colombian Expanded Program On Immunization. Value Health Reg Issues. 2021;26:150–159. doi: 10.1016/j.vhri.2021.06.001
  • Seinfeld J, Rosales ML, Sobrevilla A, et al. Economic assessment of incorporating the hexavalent vaccine as part of the National Immunization Program of Peru. BMC Health Serv Res. 2022 May 16;22(1):651. doi: 10.1186/s12913-022-08006-1
  • Olivera I, Grau C, Dibarboure H, et al. Valuing the cost of improving Chilean primary vaccination: a cost minimization analysis of a hexavalent vaccine. Health Serv Res. 2020 Apr 9;20(1):295. doi: 10.1186/s12913-020-05115-7
  • Global Polio Eradication Initiative. GPEI Strategy 2022-2026. Accessed 2023 Oct 20. Available from: https://polioeradication.org/gpei-strategy-2022-2026/.
  • Global Polio Eradication Initiative. Circulating vaccine-derived poliovirus. Accessed 2023 Oct 20. Available from: https://polioeradication.org/polio-today/polio-now/this-week/circulating-vaccine-derived-poliovirus/.
  • Global Polio Eradication Initiative. Inactivated poliovirus vaccine. Accessed 2023 Oct 20. Available from: https://polioeradication.org/polio-today/polio-prevention/the-vaccines/ipv/.
  • Vidor E. Poliovirus vaccine - inactivated. In: Plotkin S, Orenstein W, Offit P, and Edwards K editors. Vaccines. 7th PA USA: Elsevier; 2018p. 841–865.
  • Falleiros-Arlant LH, Torres JR, Lopez E, et al. Current regional consensus recommendations on infant vaccination of the Latin American pediatric infectious diseases society (SLIPE). Expert Rev Vaccines. 2020 Jun;19(6):491–498. doi: 10.1080/14760584.2020.1775078
  • Torres-Martinez C, Chaparro E, Marino AC, et al. Recommendations for modernizing infant vaccination schedules with combination vaccines in Colombia and Peru. Rev Panam salud publ. 2023;47:e24. doi: 10.26633/RPSP.2023.24
  • Namazova-Baranova L, Kharit S, Perminova O, et al. Safety and immunogenicity of fully liquid hexavalent DTaP-IPV-HepB-Hib vaccine in healthy infants in Russian Federation. Epidemiol Vaccinal Prevention. 2019;18(3):28–39.
  • Marjenberg Z, Wright C, Pooley N, et al. Hepatitis B surface antigen prevalence and the rates of mother-to-child transmission of hepatitis B virus after the introduction of infant vaccination programs in South East Asia and Western Pacific regions: a systematic review. Inter J Infect Dis. 2022 Nov;124:65–75. doi: 10.1016/j.ijid.2022.09.003
  • Stevens CE, Toy P, Kamili S, et al. Eradicating hepatitis B virus: the critical role of preventing perinatal transmission. Biologicals. 2017 Nov;50:3–19.
  • Australian Government Department of Health and Aged Care. National notifiable diseases surveillance System (NNDSS) public datasets. Accessed 2023 Oct 20. Available from: https://www.health.gov.au/resources/collections/nndss-public-datasets?utm_source=health.gov.au&utm_medium=callout-auto-custom&utm_campaign=digital_transformation.
  • Aljunid SM, Al Bashir L, Ismail AB, et al. Economic impact of switching from partially combined vaccine “Pentaxim(r) and hepatitis B” to fully combined vaccine “Hexaxim(R)” The Malaysian National Immunization Program. BMC Health Services Res. 2022 Jan 5;22(1):34.
  • Min S, Kwon SH, Lee YW, et al. Estimating the total societal cost of a hexavalent vaccine versus a pentavalent vaccine with hepatitis B in South Korea. Vaccines (Basel). 2023 May 15;11(5):984. doi: 10.3390/vaccines11050984
  • RJ GP. Vaccine manufacturing. In: Plotkin S, Orenstein W, Offit P Edwards K, editors. Vaccines. 8 ed. PA USA: Elsevier; 2018. p. 51–60.
  • Vidor E, Soubeyrand B. Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools. Expert Rev Vaccines. 2016 Dec;15(12):1575–1582. doi: 10.1080/14760584.2016.1205492.
  • European Medicines Agency. Hexacima EPAR. Assessment Report. Accessed 2023 Oct 20. Available from: https://www.ema.europa.eu/en/documents/assessment-report/hexacima-epar-public-assessment-report_en.pdf.
  • WHO. Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines, replacement of annex 2 of WHO TRS, no. 878. WHO TRS no 979. Accessed 2023 Oct 20. Avalable from: https://www.who.int/publications/m/item/acellular-pertussis-vaccines-annex-4-trs-no-979.
  • Hansen B, Sokolovska A, HogenEsch H, et al. Relationship between the strength of antigen adsorption to an aluminum-containing adjuvant and the immune response. Vaccine. 2007 Sep 4;25(36):6618–6624. doi: 10.1016/j.vaccine.2007.06.049
  • Hem SL, Hogenesch H. Relationship between physical and chemical properties of aluminum-containing adjuvants and immuno- potentiation.Expert Rev Vaccines. 2007 Oct;6(5):685–698. doi: 10.1586/14760584.6.5.685
  • De Coster I, Fournie X, Faure C, et al. Assessment of preparation time with fully-liquid versus non-fully liquid paediatric hexavalent vaccines. A time and motion study. Vaccine. 2015 Jul 31;33(32):3976–3982. doi: 10.1016/j.vaccine.2015.06.030
  • Lee YH, Harris RC, Oh HW, et al. Vaccine-related errors in reconstitution in South Korea: a national physicians’ and nurses’ survey. Vaccines (Basel). 2021 Feb 2;9(2):117. doi: 10.3390/vaccines9020117
  • Icardi G, Orsi A, Vitali Rosati G, et al. Preferences of healthcare professionals regarding hexavalent pediatric vaccines in Italy: a survey of attitudes and expectations. J Preventive Med Hygeine. 2020 Sep;61(3):E424–E444.
  • Lloyd AJ, Nafees B, Ziani E, et al. What are the preferences of health care professionals in Germany regarding fully liquid, ready-to-use hexavalent pediatric vaccine versus hexavalent pediatric vaccine that needs reconstitution? Patient Preference Adherence. 2015;9:1517–1524. doi: 10.2147/PPA.S87229
  • Bakhache P, Virey B, Bienenfeld C. Knowledge and practices regarding infant vaccination: results of a survey of French physicians. Eur J Pediatr. 2019 Apr;178(4):533–540. doi: 10.1007/s00431-018-03314-3
  • Cuesta Esteve I, Fernandez Fernandez P, Lopez Palacios S, et al. Health care professionals’ preference for a fully liquid, ready-to-use hexavalent vaccine in Spain. Prev Med Rep. 2021 Jun;22:101376.
  • Decker M, Edwards K, Bogaerts H. Combination vaccines. In: Plotkin S, Orenstein W, Offit P Edwards K, editors. Vaccines. 7th ed. PA USA: Elsevier; 2018. p. 198–227.
  • Puente Gomez I, Verheust C, Hanssens L, et al. Safety profile of Infanrix hexa - 17 years of GSK’s passive post-marketing surveillance. Expert Rev Vaccines. 2020 Aug;19(8):771–779. doi: 10.1080/14760584.2020.1800458
  • European commission: Eurostat. Causes of death – infant mortality by country of occurrence. Accessed 2023 Oct 20. Available from: https://ec.europa.eu/eurostat/web/products-datasets/-/hlth_cd_ainfo.
  • Puliyel J, Sathyamala C. Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. Indian J Med Ethics. 2018 Jan;3(1):43–47. doi: 10.20529/IJME.2017.079