A DTaP–IPV//PRP∼T vaccine (Pentaxim™): a review of 16 years’ clinical experience

Abstract

Owing to their low reactogenicity, confirmed efficacy and availability in combination vaccines, acellular pertussis (aP)-inactivated poliovirus (IPV) combined vaccines are now included in various national immunization programs worldwide. We provide an overview of 16 years of clinical experience with a diphtheria (D), tetanus (T), aP, IPV and Haemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (PRP∼T) combined vaccine (DTaP–IPV//PRP∼T – Pentaxim™, Sanofi Pasteur, France). Good immunogenicity has been demonstrated after primary vaccination with Pentaxim, regardless of the population ethnicity and primary vaccination schedule. A booster vaccination in the second year of life also resulted in a high immune response for each antigen. Furthermore, 10 years of national surveillance in Sweden has demonstrated the effectiveness of Pentaxim in controlling pertussis. As is the case for other aP-containing combined vaccines, Pentaxim is well tolerated, with the safety profile being better than for whole-cell pertussis-containing combination vaccines for primary and booster vaccinations.

Keywords::

• effectiveness
• immunogenicity
• pediatric combination vaccine
• pentavalent
• Pentaxim
• public health
• safety

Acknowledgements

The authors would like to thank David Johnson, Emmanuel Vidor and Philippe André for their valuable contributions in the review of this article; all are employees of Sanofi Pasteur. In addition, the authors thank Roberto Tapia-Conyer of the Instituto Carso de la Salud, Mexico for his input into early drafts of this article.

Financial & competing interests disclosure

Stanley Plotkin has received payments for consultancy services to Sanofi Pasteur regarding a broad range of vaccines and their development; Shabir Madhi has acted as an investigator for clinical trials sponsored by Sanofi Pasteur, although has received no direct payment from Sanofi Pasteur for acting in this capacity. All authors have received honoraria from Sanofi Pasteur for attendance at international conferences and presentation of Sanofi Pasteur-sponsored clinical trial data or participation in Sanofi Pasteur-sponsored seminars.

In addition, Shabir Madhi and Johannes Liese have received research-grant support from GlaxoSmithKline (GSK) and Pfizer (Wyeth) and have been on the speakers bureau and received honoraria from Pfizer (Wyeth) and GSK, and Novartis (Johannes Liese only). Both have received consultancy fees from GSK; Shabir Madhi has also received consultancy fees from Merck and Novartis, and Johannes Liese has also received consultancy fees from AstraZeneca. Stanley Plotkin has received consultancy fees from all major vaccine manufacturers.

Stanley Plotkin, Johannes Liese and Shabir Madhi have received no payment from Sanofi Pasteur for their contribution to the production of this article. Esteban Ortiz is currently employed by Sanofi Pasteur. 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 materials discussed in the manuscript apart from those disclosed.

Funded writing assistance was utilized in the early draft of this manuscript. The authors would like to thank Melanie Lee of Dianthus Medical Limited and Andrew Lane of Sanofi Pasteur for valuable assistance in the preparation of the manuscript in accordance with the European Medical Writers Association guidelines and Good Publication Practice.