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Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: a review
Francesca Fortunato1, Domenico Martinelli1, Pier Luigi Lopalco2
1Policlinico Riuniti Foggia Hospital, Hygiene Unit, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Insights
The DTaP5-IPV-Hib-HepB vaccine shows a good safety profile in infants and toddlers, including preterm infants. Post-marketing data, though limited, support its safety, with no significant interactions with other pediatric vaccines observed.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- The DTaP5-IPV-Hib-HepB vaccine is a recently approved hexavalent combination vaccine.
- It provides immunization against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and hepatitis B.
- Approved in Europe (2016) and the US (2018), it's used for primary and booster vaccinations in infants and toddlers.
Purpose of the Study:
- To evaluate the safety of the DTaP5-IPV-Hib-HepB vaccine.
- To assess safety data from clinical trials and post-marketing use.
- To specifically examine safety in special populations, such as preterm infants.
Main Methods:
- Review of clinical trial data.
- Analysis of post-marketing surveillance data.
- Inclusion of data on specific infant populations, including preterm infants.
Main Results:
- The DTaP5-IPV-Hib-HepB vaccine demonstrates a favorable safety profile.
- Its safety is comparable to other approved pentavalent and hexavalent vaccines.
- No significant safety concerns were identified in preterm infants.
Conclusions:
- The DTaP5-IPV-Hib-HepB vaccine is safe for infants and toddlers.
- Available data indicate no adverse interactions with co-administered pediatric vaccines.
- Further post-marketing data collection is beneficial, especially for specific vaccine usage shares.
Introduction:
The DTaP5-IPV-Hib-HepB vaccine is the most recently approved combination hexavalent vaccine. In Europe, it is licensed since 2016 for primary and booster vaccination in infants and toddlers above the age of 6 weeks to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis, invasive diseases caused by Haemophilus influenzae type b and hepatitis B. In the US, DTaP5-IPV-Hib-HepB is approved since 2018 in children 6 weeks through 4 years of age. Its safety profile has been extensively documented in infants and children born at term, and also data in preterm infants are made available.
Areas Covered:
In this article, we conducted a safety evaluation of the DTaP5-IPV-Hib-HepB vaccine in infants and toddlers considering evidence from clinical trials and post-marketing use, also with regard to data on special populations e.g. preterm infants.
Expert Opinion:
Based on the available data, the DTaP5-IPV-Hib-HepB vaccine has demonstrated a good safety profile, similar to that of other approved penta- and hexavalent vaccines. Rather, post-marketing data are limited and are frequently reported in combination with other hexavalent vaccines or are not adjusted for shares of vaccines use. Neither relevant interferences with other co-administered pediatric vaccines nor safety issues in premature infants have been shown.
