PHILADELPHIA, PA—The safety and immunogenicity of the investigational combination vaccine, DTaP5-IPV-Hib-HepB, when given as a 3-dose infant series, were comparable to equivalent licensed component vaccines, a study reported at IDWeek 2014.
“DTaP5-IPV-Hib-HepB provides a new hexavalent option for pediatric combination vaccines, aligned with recommended U.S. immunizations,” reported Gary S. Marshall, MD, from Pediatrics, University of Louisville School of Medicine, Louisville, KY. Dr. Marshall and colleagues conducted a multicenter, open-label, comparator-controlled, Phase 3 study in healthy infants, randomized to receive one of 2 immunization regimens 2:1 (DTaP5-IPV-Hib-HepB or control).
Group 1 (Study vaccine) received DTaP5-IPV-Hib-HepB, Prevnar 13 (PCV13), and RotaTeq (RV5), at 2, 4 and 6 months. This was followed by Daptacel (DTaP5), PedvaxHIB (PRP-OMPC), and Prevnar 13 (PCV13), at 15 months.
Group 2 (Control) received Pentacel (DTaP5-IPV-Hib), Recombivax HB (HepB) (not given at 4 months), Prevnar 13 (PCV13), and RotaTeq (RV5) at 2, 4 and 6 months. This was followed by Daptacel (DTaP5), ActHIB (PRP-T), Prevnar 13 (PCV13), at 15 months.
A total of 981 subjects were vaccinated in Group 1 and 484 in the control Group 2, and all received HepB in the first month of life. In Group 1 and Group 2 respectively, patients were 51.4% and 56.1% male, with a mean age range of 46–89 and 47–87 days, a mean weight range of 3–8kg in both groups, and primarily Caucasian (77.6% and 82.5%).
One month after dose 3, immune responses to all DTaP5-IPV-Hib-HepB antigens were non-inferior in Group 1 compared to Group 2, except for anti-filamentous hemagglutinin (FHA, a pertussis antigen) GMTs (46.59 vs. 72.28, ratio 0.64; 95% CI 0.59, 0.70). Response to concomitant RV5, measured as anti-rotavirus IgA GMT, was non-inferior in Group 1 compared to Group 2. One month after toddler dose, immune responses to all pertussis antigens were non-inferior in Group 1 compared to Group 2. Vaccine response rates for FHA were non-inferior to control.
Adverse event rates were mild-to-moderate and similar in both groups, with no withdrawals. Subjects in Group 1 experienced increased injection-site erythema (48.8% vs. 42.2%, difference 6.5% [1.1, 11.9]), increased fever (47.4% vs. 34.4%, difference 13.1% [7.7, 18.3]), and decreased appetite (48.9% vs. 43.3%, difference 5.6% [0.2, 11.0]). Fever was not associated with hospitalization or seizures.
“DTaP5-IPV-Hib-HepB, when given as a 3-dose infant series, represents a promising combination vaccine for introduction into the U.S. schedule,” concluded Dr. Marshall.