Immunogenicity and safety of a 2 + 1 schedule of the DTaP-IPV-HB-Hib hexavalent combination vaccine in preterm infants in Spain.
Ignacio Salamanca de la Cueva, María González López, Reyes Roldán López et al.
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In 30 seconds
This multicenter, open-label phase IV trial assessed the immunogenicity and safety of a 2 + 1 schedule of the DTaP-IPV-HB-Hib hexavalent vaccine in preterm infants in Spain. A total of 143 infants were vaccinated, achieving post-dose 3 seroprotection rates of 100% for diphtheria, tetanus, and polio, and 94.5% for hepatitis B. The study indicates the vaccine is both immunogenic and well tolerated in this vulnerable population.
Key findings
- Post-dose 3 seroprotection rates were 100% for diphtheria, tetanus, and polio.
- 94.5% of infants achieved seroprotection against hepatitis B.
- 94.1% and 76.5% vaccine response rates were observed for pertussis toxoid and filamentous hemagglutinin, respectively.
- 51.0% of participants experienced solicited adverse events within 7 days post-vaccination.
Why it matters
Understanding the immunogenicity and safety of vaccines in preterm infants is crucial, as they are at higher risk for infections and complications. This study provides evidence supporting the use of hexavalent vaccines in this population.