Clinical studies consistently show that hexavalent vaccines are highly effective in generating protective immune responses against all six targeted diseasesGo to footnote 1, Go to footnote 2, Go to footnote 3, Go to footnote 4, Go to footnote 5, Go to footnote 6, Go to footnote 7, Go to footnote 8, Go to footnote 9 :
- Diphtheria - Nearly all children achieve seroprotective antibody levels after vaccination and booster doses with non-inferior protection compared to monovalent or pentavalent vaccines. Go to footnote 10
- Tetanus - 100% seroprotection rates reported post-booster; strong and persistent antibody responses with no evidence of reduced efficacy compared to monovalent or other combination vaccines. Go to footnote 11
- Pertussis - High seroconversion rates (94–95% for Bordetella pertussis, 77–87% for pertussis toxin). Head-to-head studies and clinical trials confirm that the immune response to pertussis antigens in hexavalent vaccines is non-inferior to that of other licensed combination vaccines, including pentavalent and monovalent formulations. Some differences in antibody levels (e.g., anti-pertussis toxin, anti-pertactin) exist, but these have not shown clear clinical relevance. Hexavalent vaccines may contain either whole cell pertussis (wP) or acellular pertussis (aP) antigens, which influence immunogenicity and reactogenicity profiles, with aP generally associated with lower reactogenicity. Go to footnote 12
- Hepatitis B - >99% seroprotection post-booster with no significant reduction compared to the monovalent vaccine. Go to footnote 13
- Hib - 96–100% achieve protective antibody levels post-primary and booster doses. There is some evidence that Hib conjugate vaccine in combination with acellular pertussis (DTaP-Hib) induces a lower antibody response than Hib conjugate in combination with whole cell pertussis (DTwP-Hib) or separately administered DTaP and Hib conjugate vaccines. Go to footnote 14
- Poliomyelitis - 98–100% seroprotection for all three poliovirus types post-booster. Non inferiority (as measures by antibody titers) has been demonstrated for wP containing Hexavalent and IPV/OPV. Go to footnote 15, Go to footnote 16, Go to footnote 17
- Go back to footnote reference 1
Boisnard F, Manson C, Serradell L, Macina D (2023). DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure. Expert Rev Vaccines. 22:1196–1213. doi:10.1080/14760584.2023.2280236.
- Go back to footnote reference 2
Dakin A, Borrow R, Arkwright P (2022). A review of the DTaP-IPV-HB-PRP-T Hexavalent vaccine in pediatric patients. Expert Rev Vaccines. 22:104–117. doi:10.1080/14760584.2023.2161519.
- Go back to footnote reference 3
Wanlapakorn N, Sarawanangkoor N, Srimuan D, Thatsanathorn T, Thongmee T, et al. (2024). Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines. Hum Vaccin Immunother. 20. doi:10.1080/21645515.2024.2352909.
- Go back to footnote reference 4
Knuf M, Haas H, García-Corbeira P, Turriani E, Mukherjee P, et al. (2021). Hexavalent vaccines: what can we learn from head-to-head studies? Vaccine. doi:10.1016/j.vaccine.2021.08.086.
- Go back to footnote reference 5
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, et al. (2024). A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers. Vaccine. 42(26):126380. doi:10.1016/j.vaccine.2024.126380.
- Go back to footnote reference 6
Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet J, et al. (2010). Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis. 10:9. doi:10.1186/1471-2334-10-9.
- Go back to footnote reference 7
Sanchez L, Rungmaitree S, Kosalaraksa P, Jantarabenjakul W, Leclercq J, Yaiprayoon Y, Midde VJ, Varghese K, Mangarule S, Noriega F (2023). Immunogenicity and safety of a hexavalent DTwP-IPV-HB-PRPT vaccine versus separate DTwP-HB-PRPT, bOPV, and IPV vaccines administered at 2, 4, 6 months of age concomitantly with rotavirus and pneumococcal conjugate vaccines in healthy infants in Thailand. Pediatr Infect Dis J. 42(8):711–718. doi:10.1097/INF.0000000000003975.
- Go back to footnote reference 8
Haemophilus influenzae type b (Hib) vaccine: WHO position paper, July 2013. Weekly Epidemiological Record. 2013;88(39):413–426.
- Go back to footnote reference 9
Patterson J, Kagina BM, Gold M, Hussey GD, Muloiwa R (2018). Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: a systematic review. Vaccine. 36:6007–6016. doi:10.1016/j.vaccine.2018.08.022.
- Go back to footnote reference 10
Wanlapakorn N, Sarawanangkoor N, Srimuan D, Thatsanathorn T, Thongmee T, et al. (2024). Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines. Hum Vaccin Immunother. 20. doi:10.1080/21645515.2024.2352909.
- Go back to footnote reference 11
Wanlapakorn N, Sarawanangkoor N, Srimuan D, Thatsanathorn T, Thongmee T, et al. (2024). Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines. Hum Vaccin Immunother. 20. doi:10.1080/21645515.2024.2352909.
- Go back to footnote reference 12
Patterson J, Kagina BM, Gold M, Hussey GD, Muloiwa R (2018). Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: a systematic review. Vaccine. 36:6007–6016. doi:10.1016/j.vaccine.2018.08.022.
- Go back to footnote reference 13
Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet J, et al. (2010). Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis. 10:9. doi:10.1186/1471-2334-10-9.
- Go back to footnote reference 14
Haemophilus influenzae type b (Hib) vaccine: WHO position paper, July 2013. Weekly Epidemiological Record. 2013;88(39):413–426.
- Go back to footnote reference 15
Knuf M, Haas H, García-Corbeira P, Turriani E, Mukherjee P, et al. (2021). Hexavalent vaccines: what can we learn from head-to-head studies? Vaccine. doi:10.1016/j.vaccine.2021.08.086.
- Go back to footnote reference 16
Sharma H, Parekh S, Pujari P, Shewale S, Desai S, et al. (2024). A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers. Vaccine. 42(26):126380. doi:10.1016/j.vaccine.2024.126380.
- Go back to footnote reference 17
Sanchez L, Rungmaitree S, Kosalaraksa P, Jantarabenjakul W, Leclercq J, Yaiprayoon Y, Midde VJ, Varghese K, Mangarule S, Noriega F (2023). Immunogenicity and safety of a hexavalent DTwP-IPV-HB-PRPT vaccine versus separate DTwP-HB-PRPT, bOPV, and IPV vaccines administered at 2, 4, 6 months of age concomitantly with rotavirus and pneumococcal conjugate vaccines in healthy infants in Thailand. Pediatr Infect Dis J. 42(8):711–718. doi:10.1097/INF.0000000000003975.
