Volume 3 • Issue 1 • 1000128 J Vaccines Vaccin ISSN:2157-7560 JVV an open access journal Research Article Open Access Lanata et al., J Vaccines Vaccin 2012, 3:1 DOI: 10.4172/2157-7560.1000128 Keywords: Vaccine; Hexavalent; Pediatric; Combination; Immunization Introduction Te investigational hexavalent vaccine (Hexaxim ™ ) is fully liquid and part of Sanof Pasteur’s AcXim family, which includes the established tetra- and pentavalent vaccines Tetraxim ® /Tetravac ® and Pentaxim ® /Pentavac ® . It combines a new Hansenula polymorpha- derived and thimerosal-free hepatitis B (Hep B) antigen [1-3] with well-established diphtheria toxoid (D), tetanus toxoid (T), acellular (2-component [pertussis toxoid (PT) and flamentous hemagglutinin (FHA)]) pertussis (aP), inactivated poliovirus (IPV), and Haemophilus infuenzae type b polysaccharide conjugated to tetanus protein (PRP-T) antigens to produce a new hexavalent vaccine. Te IPV and PRP-T antigens are WHO pre-qualifed [4] as standalone vaccines (Imovax ® Polio and ActHib ® , respectively). Te immunogenicity and safety of the new Hep B antigen have been described following both monovalent administration to adults and adolescents [5] as well as following administration of the new hexavalent vaccine in several pediatric clinical studies in a range of ethnic populations and administration schedules [6-8]. Accepted advantages of combination vaccines include a reduced number of injections coupled with increased compliance to increasingly challenging pediatric vaccination schedules, leading to improved disease control with associated reduced direct and indirect costs [9]. Te routine use of combination vaccines has been crucial in reducing the incidence of childhood diseases [9]. However, regional disparities remain, such as the use of combination vaccines based on aP versus whole-cell pertussis (wP) vaccines or the inclusion or not of hepatitis B and/or IPV versus the use of a standalone hepatitis B vaccine and/or the oral poliovirus vaccine (OPV). Te investigational vaccine, including acP and IPV valences, aims to provide protection against six diseases that are considered by WHO to be priorities and is presented in a ready-to-use, fully liquid formulation. Being a fully liquid vaccine, Hexaxim minimizes human error associated with vaccine re-constitution, and helps to improve vaccination compliance. But more importantly, the introduction of a second hexavalent vaccine against D, T, P, IPV, hepatitis B, and Hib, will be vital in the event of global production and supply ruptures, which can arise intermittently even when established, well-monitored and controlled processes are in place. In such instances, the availability of a second hexavalent vaccine will mean that vaccination coverage rates could be more easily maintained globally, minimising potential outbreaks of these six pediatric infectious diseases. Tis clinical study was performed to document immunogenicity and safety data in a Peruvian pediatric population following administration of the investigational hexavalent vaccine at 2, 4 and 6 *Corresponding author: Eduardo Santos-Lima, Director, Clinical Development, Sanofi Pasteur, 1541 avenue, Marcel Mérieux, 69280 Marcy l’Etoile, France, Tel: +33 (0) 4 37 37 58 53; Fax: + 33 (0) 4 37 37 78 88; E-mail: eduardo.santos-lima@sanofipasteur.com Received January 10, 2012; Accepted March 12, 2012; Published March 18, 2012 Citation: Lanata C, Zambrano B, Ecker L, Amemiya I, Gil A, et al. (2012) Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru. J Vaccines Vaccin 3:128. doi:10.4172/2157- 7560.1000128 Copyright: © 2012 Lanata C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru Claudio Lanata 1 , Betzana Zambrano 2 , Lucie Ecker 1 , Isabel Amemiya 1 , Ana Gil 1 and Eduardo Santos Lima 3 * 1 Instituto de Investigación Nutricional, Lima, Peru 2 Sanof Pasteur, Montevideo, Uruguay 3 Clinical Development, Sanof Pasteur, Lyon, France Abstract Objectives: To assess the immunogenicity and safety of a new candidate, fully liquid, hexavalent DTaP-IPV- Hep B-PRP-T vaccine (Hexaxim™, an AcXim family vaccine) compared to a licensed hexavalent DTaP-IPV-Hep B// PRP-T vaccine (Infanrix hexa ® ) in Peru. Methods: Infants born to HBsAg seronegative mothers and who had not received a hepatitis B vaccine prior to entry into the study were randomized to receive either Hexaxim™ (Group 1) or Infanrix hexa ® (Group 2) at 2, 4, 6 months of age. Seroprotection (SP) rate for hepatitis B (anti-HBs antibody concentration ≥10 mIU/mL) was analysed for non-inferiority (Group 1 minus Group 2) 1 month post-primary series. Anti-diphtheria and anti-polyrosil ribitol phosphate (PRP) antibody responses were analysed descriptively. Safety was analysed from parental reports. Results: Seroprotection rate for anti-HBs antibody titers ≥10 mIU/mL was high in both groups (≥99.2%) and non-inferiority was demonstrated (lower bound of the 95% CI for the difference was -4.17, above the pre-defned delta [-10%]). Post-primary SP rates for anti-diphtheria (≥95.5% ≥0.01 IU/mL), anti-PRP (≥99.2% ≥0.15 µg/mL), and anti-HBs ≥100 mIU/mL (≥93.9%), were similar in each group. Both vaccines were well tolerated. The incidence of serious adverse avents was low and similar in each group, and none was considered to be vaccine related. Conclusions: In a 2, 4, 6 month schedule in Peruvian infants, the investigational DTaP-IPV-Hep B-PRP-T fully liquid vaccine provided high immunogenicity for HBs, diphtheria and PRP vaccine antigens that was comparable to the licensed hexavalent vaccine. Both vaccines had a similar safety profle. Journal of Vaccines & Vaccination J o u r n a l o f V a c c i n e s & V a c c i n a t i o n ISSN: 2157-7560