Combined immunogenicity data for a new DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim™) following primary series administration at 2, 4, 6 months of age in Latin America

The immunogenicity of a primary series of a new, fully liquid DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim™), administered at 2, 4, 6 months of age in four clinical studies is reviewed. Immunogenicity data at 1 month after the third vaccination were assessed and pooled from a total of 1270 participants (per-protocol population) in four randomized clinical trials in Argentina, Mexico, and Peru. Hepatitis B vaccine was not administered at birth. All seroprotection (D, T, polio-1, -2, -3, Hep B, PRP-T [Hib]), seroconversion (PT and FHA), and vaccine response (PT and FHA) data were high, and were similar to licensed comparators (pooled SP, SC, and VR rates were 97.1–100%, 96.0–97.0%, and 99.7–99.9%, respectively). These data show the good immunogenicity of this new hexavalent vaccine that can provide the opportunity to increase global compliance to complex pediatric vaccination schedules.

► Hexaxim™ immunogenicity was strong and consistent in 4 trials (2–4–6-month schedule).
► Pooled data showed high seroprotection, seroconversion, and vaccine response rates.
► When tested, non-inferiority was demonstrated against licensed comparators.