Immunogenicity and Safety of an Investigational Hexavalent Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus-hepatitis B-Haemophilus influenzae B Conjugate Combined Vaccine in Healthy 2-, 4-, and 6-month-old Argentinean Infants

Abstract

The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

“…This previous study showed noninferiority of immune responses for all antigens, including HB (with no HB vaccination at birth). Compared to the present study, the HB response has been higher postprimary vaccination series for the less challenging 2, 4, 6 month schedule (13) or postbooster when a HB dose had been administered at birth (14). However, the differences in study design in terms of vaccination schedule and the administration of a birth dose of HB compound comparisons between studies and more importantly numerous studies have consistently shown noninferiority of immune responses against HB to both standalone HB vaccine and to HB antigens included in multivalent comparator vaccines, in a range of schedules, both with and without HB vaccination at birth.…”

“…With the exception of the HB antigen, all antigens included in the fully liquid hexavalent vaccine have been extensively studied both as part of the pentavalent vaccine (Pentaxim/Pentavac) (4) and also in a clinical trial designed specifically to assess the noninferiority of all antigens to Pentaxim/Pentavac and a standalone HB vaccine (13). This previous study showed noninferiority of immune responses for all antigens, including HB (with no HB vaccination at birth).…”

“…In previous studies, the investigational DTaP-IPV-HB-PRP-T vaccine has been shown to be safe and immunogenic when administered in a 3-dose primary series schedule at 2, 4, and 6 months (7) and 6, 10, and 14 weeks (10), with or without the administration of a standalone HB vaccine at birth (10)(11)(12)(13). Additionally, a booster dose in the second year of life has been shown to be safe and to elicit an anamnestic response irrespective of HB vaccination at birth (11,14).…”

Safety and Immunogenicity of an Investigational Fully Liquid Hexavalent DTaP-IPV-Hep B-PRP-T Vaccine at Two, Four and Six Months of Age Compared With Licensed Vaccines in Latin America

“…5 This phase III study in Mexico and Peru was primarily to assess the safety of the investigational hexavalent vaccine in comparison with a commercially available pentavalent vaccine given concomitantly with OPV. The robust primary series immunogenicity of the Hep B valence with and without Hep B at birth has been confirmed as a primary objective in other clinical studies, [20][21][22] and so in our study the immunogenicity of the Hep B valence of this investigational vaccine was assessed as a secondary objective and only in a subgroup of Mexican participants (who had not received Hep B at birth, in accordance with the national vaccination calendar in place in Mexico at the time of the study).…”

Vacunación frente a la hepatitisB. Impacto de los programas de vacunación tras 20años de su utilización en España. ¿Es tiempo de cambios?

“…Por su parte, las vacunas combinadas ofrecen, con una sola administración, protección frente a un mayor número de enfermedades, lo que favorece el cumplimiento del calendario de vacunación, y además obtienen una mayor aceptación entre los padres por la disminución del número de pinchazos y la simplificación de la pauta 27,28 . Existen 2 vacunas hexavalentes combinadas comercializas en España (Infanrix Hexa ® y Hexyon ® ), y ambas ofrecen una buena inmunogenicidad, eficacia y tolerabilidad frente a los antígenos que contienen: difteria (D), tétanos (T), tos ferina acelular (Pa), HB, polio inactivada (VPI) y Haemophilus influenzae b (Hib) [29][30][31][32] .…”