Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent
DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-
PRP-T booster at 15?18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no
hepatitis B [HB] at birth) of DTaP-IPV-HB-
PRP-T (N = 155) (group 1) or licensed control
vaccines (DTaP-IPV//
PRP-T and standalone
HB: N = 155) (group 2) and DTaP-IPV-HB-
PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports. Results: Postprimary series noninferiority of anti-HB ≥ 10 mIU/mL was demonstrated for the
DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each
antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-
PRP-T than for standalone HB. For each
antigen except HB, DTaP-IPV-HB-
PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups. Conclusion: The
DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.