Session:

Vaccines & Vaccine Development

Abstract No.:

48.030

Title:

Immunogenicity and safety of a primary series of a new fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine (Hexaxim™) co-administered with Prevenar™ and Rotarix™ in healthy children in Latin America

Author(s):

P. Lopez¹, A. Arguedas Mohs², M.-C. Miranda³, B. Zambrano⁴, E. Santos Lima⁵; ¹Centro de Estudios en Infectologia Pediatrica, Departamento de Estudios en Infectologia Pediatrica, Cali/CO, ²Instituto de Atención Pediátrica, National Children's Hospital, San José de Costa Rica/CR, ³Sanofi Pasteur, Clinical Development, Bogota/CO, ⁴Sanofi Pasteur, Clinical Development, Montevideo/UY, ⁵Sanofi Pasteur, Clinical Development, Marcy l'Etoile/FR

Abstract:

Background: Lot-to-lot consistency study assessing primary series vaccination with a new, fully liquid, DTaP‑IPV‑Hep B‑PRP-T vaccine (Hexaxim™ - an AcXim family vaccine), incorporating the new Hansenula polymorpha‑derived Hep B antigen (Sanofi Pasteur), co-administered with Prevenar™ and Rotarix™.
Methods: Phase III, randomized, observer-blind, two-centre study.  Subjects received Hexaxim (Group 1: N=1002 [3 lots-pooled]) or Infanrix hexa™ (Group 2: N=338) at 2,4,6 months-of-age, co-administered with Prevenar (PCV7: 2, 4, 6 months) and Rotarix (2, 4 months).  Hep B was given at birth. Antibody concentrations or titers were measured pre-(Hep B, D, PT, FHA) and 1 month post-(all valences) primary series for Hexaxim and Infanrix hexa. Equivalence of Hexaxim lots was tested. Non‑inferiority analyses were performed for Group 1 versus Group 2 for seroprotection (SP: anti- Hep B, PRP, D, T, and polio 1/2/3) and vaccine response (VR: anti-PT and FHA) rates. Anti-PCV7 (7 months) and anti-rotavirus IgA (5 months) were also assessed. Safety after each dose was compared descriptively.
Results: Equivalence was demonstrated for the Hexaxim lots, so Group 1 data were pooled for non-inferiority testing (per protocol analysis set). For all SP and VR rates, Group 1-minus-Group 2 non-inferiority was demonstrated (lower 95% CI bound for each difference was greater than the pre-specified non‑inferiority margin).  Anti-Hep B GMCs were similar in Groups 1 and 2 (3013 and 2766 mIU/mL); anti-PRP was higher in Group 1 (3.56 versus 2.24 µg/mL). There were no clinically relevant differences in the immune responses to Prevenar or Rotarix following co-administration with Hexaxim or Infanrix hexa. Reactogenicity was similar in each group and no vaccine‑related SAEs were reported.

Table 1: SP or VR (95% CI)