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

• DOI: 10.1097/inf.0b013e318258400d
• Publication Date: 2012-04-24T22:32:01Z
• Authors: Mercedes Macías; Claudio F. Lanata; Betzana Zambrano; Ana I. Gil; Isabel Amemiya; Monica Mispireta; Lucie Ecker; Eduardo Santos-Lima
• Keywords: Reactogenicity; Hepatitis B; Group B

This trial assessed the safety of a fully liquid investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine containing 10 μg Hansenula polymorpha-derived recombinant hepatitis B (hep B) antigen for primary vaccination infants at 2, 4 and 6 months age compared with licensed comparators.Participants received (group 1, N = 1422) or DTwP-Hep B//Hib (Tritanrix-Hep B/Hib) oral poliovirus vaccines 711). The incidence severe fever (≥ 39.6°C rectal equivalent) in 2 groups was statistically; reactogenicity evaluated from parental reports. Anti-Hep antibody titers were measured subset participants (no birth) 1 month after dose 3.The well tolerated. After any dose, (rectal equivalent temperature ≥ 38°C) observed 74.8% 92.7% 2; 4.0% 5.5% participants. Solicited injection site systemic reactions numerically less frequent group than although this difference not statistically. In both groups, all included immunogenicity analysis achieved anti-Hep mIU/mL 96.2% 100 mIU/mL, geometric mean titer approximately 3-fold lower vaccine.This new, acellular pertussis demonstrated comparator whole cell highly immunogenic new Hep valence.