Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, PedvaxHIB®, and INFANRIX®) were combined. Among 4,374 participants receiving ≥ 1 dose of HAVi, 4,222 (97%) had safety follow-up and the proportions reporting adverse events (AE) were comparable when administered alone (69.4%) or concomitantly with other pediatric vaccines (71.1%). The most common solicited injection-site AEs were pain/tenderness (Postdose 1: 25.8%; Postdose 2: 26.1%) and redness (Postdose 1: 13.6%; Postdose 2: 15.1%). The most common vaccine-related systemic AEs were fever (≥ 100.4ºF, 12.2%) and irritability (8.1%). Serious AEs (SAEs) were observed at a rate of 0.4%; 0.1% were considered vaccine-related. No deaths were reported within 14 days following a dose of HAVi. These integrated analyses also showed that protective antibody concentrations were elicited in 100% of toddlers after two doses and 92% after a single dose, regardless of whether HAVi was given concomitantly with other vaccines or alone. These results demonstrate that HAVi was well-tolerated whether given alone or concomitantly with other vaccines, with a low incidence of vaccine-related SAEs. HAVi was immunogenic in this age group regardless of whether administered with or without other pediatric vaccines and whether 1 or 2 doses were administered. HAVi did not impact the immune response to other vaccines. These data continue to support the routine use of HAVi with other pediatric vaccines in children ≥ 12 months of age.

Vaxelis^® is a fully liquid, ready-to-use, hexavalent vaccine approved in the EU for primary and booster vaccination in infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). It contains diphtheria and tetanus toxoids, five acellular pertussis antigens, recombinant hepatitis B virus surface antigen produced in the yeast, Saccharomyces cerevisiae, inactivated poliovirus, and the Hib polysaccharide (polyribosylribitol phosphate) conjugated to the outer membrane protein complex of Neisseria meningitidis. In pivotal clinical studies, Vaxelis^® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules. Primary endpoints of seroprotection or vaccine response rates with Vaxelis^® met the predefined acceptability criteria and were noninferior to those with comparator vaccines (Infanrix^® hexa or Pentacel^® plus Recombivax HB^®). Limited data indicate that immune responses to Vaxelis^® in preterm infants were generally similar to those seen in the overall population. Vaxelis^® can be coadministered with a number of common childhood vaccines. In clinical studies, Vaxelis^® was generally well tolerated with a tolerability profile similar to that of the comparator vaccines. Available clinical data indicate that Vaxelis^® is a new hexavalent vaccine option for immunization against several serious childhood infectious diseases.