Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children

Abstract

Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, safety, and tolerability of Vaqta® (hepatitis A vaccine) administered with PedvaxHIB® (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & Infanrix® (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 15-month-old children. Five groups were evaluated: Group 1 received Vaqta®/Infanrix® PedvaxHIB® on Day-1 and Vaqta® at Week-24; Group 2 received Infanrix® PedvaxHIB® on Day-1, Vaqta® at Week-4, and Vaqta® at Week-28; Group 3 received Vaqta®/PedvaxHIB® on Day-1 and Vaqta® Week-24; Group 4 received PedvaxHIB® on Day-1, Vaqta® at Week-4, and Vaqta® at Week-28; and Group 5 (safety only) received Vaqta® on Day-1 and Vaqta® at Week-24. Hepatitis A seropositivity rate (SPR: ≥10 mIU/mL), Hib capsular polyribosylribitol phosphate (PRP) antibody response (>1.0 μg/mL), and geometric mean titers (GMT) to pertussis toxin (PT), pertussis filamentous hemagglutinin antibody (FHA), and pertactin were examined. Non-inferiority statistical criteria required a difference >10% in Hepatitis A SPR, PRP >1.0 μg/mL, and a GMT ratio of >0.67 for pertussis antigens. Injection-site and systemic adverse events (AEs) and daily temperatures were collected. Hepatitis A SPRs were 100% for Groups 1–4, regardless of initial serostatus. Anti-PRP titers were comparable (98.1% - 97.0%) for Groups 1–4. GMT and mean fold-rise were comparable for all 3 pertussis antigen components between concomitant and nonconcomitant groups. Criteria for non-inferiority of immune responses for concomitant vs nonconcomitant administration were met for Hepatitis A, Hib, and pertussis antigens. No statistically significant incidence differences of individual AEs were found between concomitant and nonconcomitant groups. No serious vaccine-related AEs or deaths were reported; no subject discontinued due to an AE. Immune responses to Vaqta®, PedvaxHIB®, and Infanrix® given concomitantly were non-inferior to nonconcomitant responses. Vaqta® administered with PedvaxHIB® & Infanrix® had an acceptable safety profile in 15-month-old children.