Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants

Area of Science:

• Immunology
• Vaccinology
• Pediatric Infectious Diseases

Background:

• DTaP5-IPV-Hib-HepB is an investigational, fully liquid hexavalent vaccine designed to protect against six diseases.
• Combination vaccines simplify immunization schedules, potentially improving compliance and reducing healthcare burden.

Purpose of the Study:

• To assess the safety and immunogenicity of the investigational hexavalent vaccine DTaP5-IPV-Hib-HepB compared to licensed component vaccines.
• To determine if DTaP5-IPV-Hib-HepB is a viable option for the US infant immunization schedule.

Main Methods:

• A multicenter, open-label, comparator-controlled, phase III study enrolled healthy infants.
• Infants were randomized to receive either DTaP5-IPV-Hib-HepB or licensed component vaccines at 2, 4, 6, and 15 months of age.
• Immune responses to all antigens and solicited adverse events were monitored.

Main Results:

• Immune responses to most antigens in the DTaP5-IPV-Hib-HepB group were noninferior to the comparator group after primary and booster doses.
• Slightly lower geometric mean concentrations for antipertussis filamentous hemagglutinin (FHA) were observed post-primary vaccination, but response rates were noninferior.
• Solicited adverse events were similar between groups, with a slight increase in injection-site erythema, fever, and decreased appetite in the DTaP5-IPV-Hib-HepB group, none of which were clinically significant.

Conclusions:

• The safety and immunogenicity profile of DTaP5-IPV-Hib-HepB is comparable to existing licensed vaccines.
• Minor increases in local reactions and fever are unlikely to be clinically significant.
• DTaP5-IPV-Hib-HepB represents a promising new combination vaccine option for routine infant immunization in the US.