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ABSTRACT
Introduction
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.
Article highlights
Hexaxim is a fully liquid, hexavalent vaccine for primary and booster vaccination of infants and toddlers from 6 weeks of age against diphtheria, tetanus, pertussis, polio, hepatitis B, and invasive diseases caused by Haemophilus influenzae type b.
Hexaxim was first approved in 2012, and an extensive program of clinical trials supports its use in a diverse range of primary series and booster schedules, including co-administration of with other routine pediatric vaccines and describes its use in specific populations (preterm and immunocompromised infants).
Antibody persistence has been demonstrated up to school age for all Hexaxim antigens, and persisting immune memory against hepatitis B has been shown to last at least 9-10 years.
In a real-world study, vaccine effectiveness of the acellular pertussis antigens included in Hexaxim was demonstrated, with sustained protection until children were scheduled to receive a school-age booster.
In the 10 years since licensure more than 180 million doses of Hexaxim have been distributed worldwide, and post-marketing surveillance has confirmed the favorable safety profile of Hexaxim following large-scale vaccination programs worldwide, which is in line with other similar multivalent pediatric vaccines.
The reliability of Hexaxim manufacturing ensures lot-to-lot consistency in terms of vaccine immunogenicity and safety.
The inclusion in Hexaxim of acellular pertussis and inactivated poliovirus antigens is aligned with modern pediatric vaccination strategies and helps to provide equitable access to the control of childhood diseases and guard against outbreaks.
Acknowledgments
Dr Andrew Lane (Lane Medical Writing) provided medical writing assistance, funded by Sanofi, in the preparation and development of the manuscript in accordance with the European Medical Writers Association guidelines and Good Publication Practice. The authors would also like to thank Lucia Bricks, Alena Khromava, and Juan Vargas-Zambrano (all employees of Sanofi) for their valuable reviews and input into the development of this manuscript.
Declaration of interests
F Boisnard, C Manson, L Serradell, and D Macina are employees of Sanofi and may hold shares and/or stock options in the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript apart from those disclosed.
LIST OF ABBREVIATIONS
| AE | = | adverse event |
| aP | = | acellular pertussis |
| DTaP-IPV | = | diphtheria, tetanus; acellular pertussis, inactivated poliovirus vaccine (Tetraxim, tetravalent vaccine, fully liquid) |
| DTaP-IPV//Hib | = | diphtheria, tetanus, acellular pertussis, inactivated poliovirus vaccine, and Haemophilus influenzae type b conjugate (Pentaxim, pentavalent vaccine, to be reconstituted) |
| DTPa-HBV-IPV/Hib | = | diphtheria, tetanus; acellular pertussis, hepatitis B, inactivated poliovirus vaccine, and Haemophilus influenzae type b conjugate (Infanrix hexa, hexavalent vaccine, to be reconstituted) |
| DTaP-IPV-HB-Hib | = | diphtheria, tetanus; acellular pertussis, inactivated poliovirus vaccine, hepatitis B, and Haemophilus influenzae type b conjugate (Hexaxim [or Hexyon, Hexacima, Hexarium depending on the country], hexavalent vaccine, fully liquid) |
| D | = | diphtheria |
| EMA | = | European Medicines Agency |
| EPI | = | Expanded Program on Immunization |
| EU | = | European Union |
| FHA | = | filamentous haemagglutinin |
| HB or Hep B | = | hepatitis B |
| HBsAg | = | hepatitis B surface antigen |
| HHE | = | hypotonic hyporesponsive episode |
| Hib | = | Haemophilus influenzae type b |
| HIV | = | human immunodeficiency virus |
| IPV | = | inactivated poliovirus vaccine |
| IU | = | International unit |
| Lf | = | limit of flocculation |
| LLOQ | = | lower limit of quantitation |
| MenACWY | = | MenACWY conjugate vaccine |
| Men B | = | meningococcal B vaccine |
| MenC | = | meningococcal C conjugate vaccine |
| O/E | = | observed to expected |
| OPV | = | oral poliovirus vaccine |
| PRN | = | pertactin |
| PRP | = | polyribosyl ribitol phosphate |
| PRP~T | = | Haemophilus influenzae type b capsular polyribosyl ribitol phosphate conjugated to tetanus toxoid |
| PT | = | pertussis toxin |
| RCT | = | randomized, controlled trial |
| SAE | = | serious adverse event |
| SIDS | = | Sudden Infant Death Syndrome |
| T | = | tetanus |
| Tdap | = | diphtheria, tetanus, pertussis (acellular component) vaccine (adsorbed, reduced antigen(s) content) |
| USA | = | United States of America |
| VAPP | = | Vaccine Associated Paralytic Polio |
| VDPV | = | Vaccine Derived Poliovirus |
| VE | = | vaccine efficacy |
| WHO | = | World Health Organization |
| wP | = | whole-cell pertussis |
Reviewer disclosures
A peer reviewer on this manuscript has disclosed that they have participated in hexavalent vaccine trials for Sanofi Pasteur, MSD and GSK and as an advisory board member for these companies. They have no shares of economic interest in these companies. All reviewers on this manuscript have received honoraria for their review work, reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
All authors made substantial contributions to the development of the work, the analysis and interpretation of the data, reviewed it critically, approved the final version to be published, and are fully accountable for all aspects of the work.
SUPPLEMENTARY MATERIAL
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2023.2280236