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Licensed Vaccines

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016)

, , , , , , , , & (for the V419-016 study group) ORCID Icon show all
Article: 2310900 | Received 15 Nov 2023, Accepted 24 Jan 2024, Published online: 08 Feb 2024

References

  • Esposito S, Tagliabue C, Bosis S, Ierardi V, Gambino M, Principi N. Hexavalent vaccines for immunization in paediatric age. Clin Microbiol Infect. 2014;20(Suppl 5):76–7. doi:10.1111/1469-0691.12444.
  • Obando-Pacheco P, Rivero-Calle I, Gomez-Rial J, Rodriguez-Tenreiro Sanchez C, Martinon-Torres F. New perspectives for hexavalent vaccines. Vaccine. 2018;36(36):5485–94. doi:10.1016/j.vaccine.2017.06.063.
  • Aquino AG, Brito MG, Doniz CE, Herrera JF, Macias M, Zambrano B, Plennevaux E, Santos-Lima E. A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children. Vaccine. 2012;30(45):6492–500. doi:10.1016/j.vaccine.2012.07.040.
  • Kosalaraksa P, Thisyakorn U, Benjaponpitak S, Chokephaibulkit K, Santos-Lima E. 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. Int J Infect Dis. 2011;15(4):e249–56. doi:10.1016/j.ijid.2010.12.004.
  • Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11–12 months. Vaccine. 2016;34(33):3810–6. doi:10.1016/j.vaccine.2016.05.054.
  • Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at two, three, four and twelve months. Pediatr Infect Dis J. 2017;36(2):209–15. doi:10.1097/INF.0000000000001406.
  • Xu J, Stek JE, Ziani E, Liu GF, Lee AW. Integrated safety profile of a new approved, fully liquid DTaP5-HB-IPV-Hib vaccine. Pediatr Infect Dis J. 2019;38(4):439–43. doi:10.1097/INF.0000000000002257.
  • Dakin A, Borrow R, Arkwright PD. A review of the DTaP-IPV-HB-PRP-T hexavalent vaccine in pediatric patients. Expert Rev Vaccines. 2023;22(1):104–17. doi:10.1080/14760584.2023.2161519.
  • Dolhain J, Janssens W, Mesaros N, Hanssens L, Fierens F. Hexavalent vaccines: increasing options for policy-makers and providers. A review of the data supporting interchangeability (substitution with vaccines containing fewer antigens) and mixed schedules from the same manufacturer. Expert Rev Vaccines. 2018;17(6):513–24. doi:10.1080/14760584.2018.1419070.
  • Obando-Pacheco P, Rivero-Calle I, Raguindin PF, Martinon-Torres F. DTaP5-HBV-IPV-Hib pediatric hexavalent combination vaccine for use in children from 6 weeks through to 4 years of age. Expert Rev Vaccines. 2019;18(11):1115–26. doi:10.1080/14760584.2019.1690457.
  • Ahonen A, Zhang Y, Marcek T, Lumley J, Johnson DR, Guris D, Wilck MB. Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-hib infant-toddler series 7 to 8 years previously. Hum Vaccin Immunother. 2022;18(5):2073747. doi:10.1080/21645515.2022.2073747.
  • Behre U, Van Der Meeren O, Crasta P, Hanssens L, Mesaros N. Lasting immune memory against hepatitis B in 12–13-year-old adolescents previously vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Hum Vaccin Immunother. 2016;12(11):2916–20. doi:10.1080/21645515.2016.1202388.
  • Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B’Chir S, Da Costa X, Vidor E. 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. Hum Vaccin Immunother. 2018;14(5):1257–65. doi:10.1080/21645515.2018.1426418.
  • Madhi SA, Lopez P, Zambrano B, Jordanov E, B’Chir S, Noriega F, Feroldi E. Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration. Hum Vaccin Immunother. 2019;15(3):658–68. doi:10.1080/21645515.2018.1546524.
  • Omenaca F, Garcia-Sicilia J, Boceta R, Sistiaga-Hernando A, Garcia-Corbeira P. Antibody persistence and booster vaccination during the second and fifth years of life in a cohort of children who were born prematurely. Pediatr Infect Dis J. 2007;26(9):824–9. doi:10.1097/INF.0b013e318124a9c8.
  • Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AWT. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020;16(4):867–74. doi:10.1080/21645515.2019.1673119.
  • Zinke M, Disselhoff J, Gartner B, JM J. a-HBV-IPV DTP, study g. Immunological persistence in 4–6 and 7–9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 2010;6(2):189–93. doi:10.4161/hv.6.2.10117.
  • Lopez P, Arguedas Mohs A, Abdelnour Vasquez A, Consuelo-Miranda M, Feroldi E, Noriega F, Jordanov E, B′chir S, Zambrano B. 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):272–82. doi:10.1097/INF.0000000000001682.
  • Costantino C, Cimino L, Bonaccorso N, Conforto A, Sciortino M, Blangiardi F, Bosco G, Canzoneri G, Casuccio N, Collura C, et al. Real life hexavalent vaccination among children as a practical guide for public health professionals: four years (from 2016 to 2019) of clinical practice in Sicily, Italy. Hum Vaccin Immunother. 2022;18(6):2141998. doi:10.1080/21645515.2022.2141998.
  • Vaxelis: product information; [Accessed Jul 2023 2022]. https://wwwmerckcom/product/usa/pi_circulars/v/vaxelis/vaxelis_pipdf.
  • Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R. Group PCs. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017;35(30):3764–72. doi:10.1016/j.vaccine.2017.05.043.
  • Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26(4):404–13. doi:10.1093/biomet/26.4.404.
  • Andrews N, Borrow R, Miller E. Validation of serological correlate of protection for meningococcal C conjugate vaccine by using efficacy estimates from postlicensure surveillance in England. Clin Diagn Lab Immunol. 2003;10(5):780–6. doi:10.1128/CDLI.10.5.780-786.2003.
  • Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17(7):1055–65. doi:10.1128/CVI.00131-10.
  • Edwards KM. Review of the laboratory approaches to the detection of antibody and cell-mediated immunity to pertussis disease and vaccine. Expert Rev Vaccines. 2014;13(10):1183–90. doi:10.1586/14760584.2014.946015.
  • Halperin SA, Langley JM, Ye L, MacKinnon-Cameron D, Elsherif M, Allen VM, Smith B, Halperin BA, McNeil SA, Vanderkooi OG, et al. A randomized controlled trial of the safety and immunogenicity of tetanus, diphtheria, and acellular pertussis vaccine immunization during pregnancy and subsequent infant immune response. Clin Infect Dis. 2018;67(7):1063–71. doi:10.1093/cid/ciy244.
  • Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, et al. Lot-to-lot consistency, safety, tolerability and immunogenicity of an investigational hexavalent vaccine in US infants. Pediatr Infect Dis J. 2017;36(2):202–8. doi:10.1097/INF.0000000000001405.
  • Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, et al. Immunogenicity, safety, and tolerability of a hexavalent vaccine in infants. Pediatrics. 2015;136(2):e323–32. doi:10.1542/peds.2014-4102.
  • Wilck MB, Jin Xu Z, Stek JE, Goveia MG, Lee AW. Protective immune responses against Haemophilus influenzae type b elicited by a fully-liquid DTaP-IPV-Hib-HepB vaccine (VAXELIS®). Vaccine. 2021;39(9):1428–34. doi:10.1016/j.vaccine.2021.01.046.
  • Santosham M, Wolff M, Reid R, Hohenboken M, Bateman M, Goepp J, Cortese M, Sack D, Hill J, Newcomer W, et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenzae type b polysaccharide and Neisseria meningitidis outer-membrane protein complex. N Engl J Med. 1991;324(25):1767–72. doi:10.1056/NEJM199106203242503.
  • Vella PP, Staub JM, Armstrong J, Dolan KT, Rusk CM, Szymanski S, Greer WE, Marburg S, Kniskern PJ, Schofield TL, et al. Immunogenicity of a new Haemophilus influenzae type b conjugate vaccine (Meningococcal protein conjugate) (PedvaxHIBTM). Pediatrics. 1990;85(4):668–75. doi:10.1542/peds.85.4.668.
  • Committee on Native American Child Health and Committee on Infectious diseases. Immunizations for native American children. Am Acad Pediatr. 1999;104(3):564–7. doi:10.1542/peds.104.3.564.
  • Singleton R, Bulkow LR, Levine OS, Butler JC, Hennessy TW, Parkinson A. Experience with the prevention of invasive Haemophilus influenzae type b disease by vaccination in Alaska: the impact of persistent oropharyngeal carriage. J Pediatr. 2000;137(3):313–20. doi:10.1067/mpd.2000.107843.