Immunogenicity and safety of a fully liquid DTaP-IPV-HB-PRP∼T hexavalent vaccine compared with the standard of care in infants in the Republic of Korea

The main exclusion criteria were: current or planned participation in another clinical trial or non-study vaccination during or in the 4weeks pre-study (except for Bacille Calmette Guerin vaccine) or any planned non-study vaccination in the 8days post-any trial vaccination; any prior vaccination against D, T, P, poliomyelitis, HB (except the birth dose of HB vaccine), Hib, or any history of these infections; receipt of blood products or of any immune-modifying treatment for more than two consecutive weeks; personal/maternal history of human immunodeficiency virus or hepatitis C seropositivity; known hypersensitivity to any study vaccine component; history of seizures; bleeding disorder contraindicating intramuscular (IM) injection; chronic or acute illness that could interfere with study conduct/completion; a child of anyone directly involved in the study. Vaccines The hexavalent, investigational vaccine, DTaP-IPV-HB-PRP~T (batch numbers K0229-F04 and L0050-F03), was manufactured by Sanofi Pasteur, France, and presented as a preservative-free, fully liquid suspension for single-dose injection (0.5mL pre-filled syringes). Each pre-filled syringe contained >=20IU (30 limit of flocculation [Lf]) D-toxoid, >=40IU (10 Lf) T-toxoid, 25µg pertussis toxin (PT) and 25µg filamentous hemagglutinin (FHA), 40, 8 and 32 D antigen units of IPV type 1, 2 and 3, respectively, 10µg HBsAg, 12µg Hib polysaccharide (PRP) conjugated to 22-36µg tetanus toxoid protein, and 0.6mg aluminum hydroxide. 13 C. Lanata, B. Zambrano, L. Ecker, I. Amemiya, A. Gil, E. Santos-Lima, Immunogenicity and safety of a fully liquid DTaP-IPV-Hep B-PRP-T vaccine at 2-4-6 months of age in Peru, Vacc Vacc, Vol. 3, 2012 14 M. Macias, C.F. Lanata, B. Zambrano,...