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ABSTRACTIntroduction Hexaxim® is fully liquid, hexavalent, combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by Haemophilus influenzae type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency.Areas covered Safety and immunogenicity data were reviewed from >25 clinical trials involving approximately 7200 infants/toddlers, identified using PubMed searches to April 2023. These trials have evaluated a diverse range of primary series and booster schedules, including antibody persistence, co-administration of Hexaxim with other routine pediatric vaccines, and specific populations (born to Tdap-vaccinated women, preterm, and immunocompromised infants). Lastly, post-marketing surveillance and real-world effectiveness data were assessed.Expert opinion An extensive program of clinical development prior to licensure demonstrated favorable vaccine safety and good immunogenicity of each antigen, and Hexaxim was first approved for use in 2012. In the 10 years since licensure, Hexaxim has been adopted widely, with more than 180 million doses distributed worldwide. The widespread use of this hexavalent vaccine is a crucial tool in the ongoing and future control of six pediatric infectious diseases globally.

Hexaxim® is fully liquid, hexavalent, combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by Haemophilus influenzae type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency. Safety and immunogenicity data were reviewed from >25 clinical trials involving approximately 7200 infants/toddlers, identified using PubMed searches to April 2023. These trials have evaluated a diverse range of primary series and booster schedules, including antibody persistence, co-administration of Hexaxim with other routine pediatric vaccines, and specific populations (born to Tdap-vaccinated women, preterm, and immunocompromised infants). Lastly, post-marketing surveillance and real-world effectiveness data were assessed. An extensive program of clinical development prior to licensure demonstrated favorable vaccine safety and good immunogenicity of each antigen, and Hexaxim was first approved for use in 2012. In the 10 years since licensure, Hexaxim has been adopted widely, with more than 180 million doses distributed worldwide. The widespread use of this hexavalent vaccine is a crucial tool in the ongoing and future control of six pediatric infectious diseases globally. [ABSTRACT FROM AUTHOR]

Introduction: Combination vaccines reduce the number of injections received by children, hence improving timeliness and coverage, and general acceptability among caregivers and health-care providers. The most recent hexavalent vaccine, DTaP5-HBV-IPV-Hib, has been also approved by the FDA. Areas covered: DTaP5-HBV-IPV-Hib has demonstrated good immunogenic and safety profiles, not inferior to other hexavalent vaccines already in use in the European market. Either (2p+1/3p+1) immunization schedules can be used with no significant differences. A low incidence of severe adverse events has been shown, similar to other combination vaccines. No issues have arisen when concomitantly administered with other vaccines. Expert opinion: The inclusion of two additional acellular pertussis components (FIM2 and FIM3) might yield better protection against the disease, but this remains to be clinically proven. The new vaccine uses Hib with unique protein carrier (PRP-OMPC) which elicits higher earlier immune response without compromising safety. Compliance with the immunization schedules is expected to increase by decreasing the number of injections needed in combined vaccines for a single visit. In addition, the improvements on the ease-of-use by its liquid-formulation, makes the vaccine preparation more acceptable for use in clinics and may reduce the odds of administration errors. [ABSTRACT FROM AUTHOR]

Introduction: Combination vaccines reduce the ‘shot burden’ and simplify the childhood immunization schedule. Only 5-valent DTaP-based vaccines are licensed in the U.S. Areas covered: A new combination vaccine – DTaP5-IPV-Hib-HepB – is described, which induces antibody responses in infants (given in different schedules, including a 2, 4, and 6-month schedule) that are similar to the respective component vaccines. The vaccine appears to be safe and would be expected to protect against six diseases: diphtheria, tetanus, pertussis, hepatitis B, H influenzae type b, and polio. Administration is associated with higher rates of mild fever, but without significant safety signals. Expert commentary: Incorporation of this hexavalent vaccine into the U.S. schedule could improve coverage rates and timeliness, and addition to the E.U. market would add depth to the available repertoire of combination vaccines.

Introduction:Combination vaccines reduce the ‘shot burden’ and simplify the childhood immunization schedule. Only 5-valent DTaP-based vaccines are licensed in the U.S. Areas covered:A new combination vaccine – DTaP5-IPV-Hib-HepB – is described, which induces antibody responses in infants (given in different schedules, including a 2, 4, and 6-month schedule) that are similar to the respective component vaccines. The vaccine appears to be safe and would be expected to protect against six diseases: diphtheria, tetanus, pertussis, hepatitis B, H influenzae type b, and polio. Administration is associated with higher rates of mild fever, but without significant safety signals. Expert commentary:Incorporation of this hexavalent vaccine into the U.S. schedule could improve coverage rates and timeliness, and addition to the E.U. market would add depth to the available repertoire of combination vaccines. [ABSTRACT FROM PUBLISHER]