Immunogenicity and Safety of a Fully Liquid DTaP-IPV-Hep B-PRP-T Vaccine at 2-4-6 Months of Age in Peru
- *Corresponding Author:
- Dr. 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: [email protected]
Received Date: January 10, 2012; Accepted Date: March 12, 2012; Published Date: 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.
Objectives: To assess the immunogenicity and safety of a new candidate, fully liquid, hexavalent DTaP-IPVHep 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-Hep B antibody concentration ≥10 mIU/mL) was analysed for non-inferiority (Group 1 minus Group 2) 1 month post-primary series. Anti-diphtheria and anti-polyribosyribitol phosphate (PRP) antibody responses were analysed descriptively. Safety was analysed from parental reports. Results: Seroprotection rate for anti-Hep B 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-defined 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-Hep B ≥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 Hep B, diphtheria and PRP vaccine antigens that was comparable to the licensed hexavalent vaccine. Both vaccines had a similar safety profile.