Integrated Safety Profile of a New Approved, Fully Liquid DTaP5-HB-IPV-Hib Vaccine

Background: DTaP5-HB-IPV-Hib is a fully liquid, hexavalent vaccine containing a 5-antigen pertussis component, approved since 2016 in Europe [Vaxelis; DTaP5-HB-IPV-Hib vaccine: Diphtheria, tetanus, pertussis (5 acellular components: pertussis toxoid [PT], filamentous haemagglutinin [FHA], pertactin (PRN), and fimbriae Types 2 and 3 [FIM]), hepatitis B (recombinant DNA: rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed); MCM Vaccine B.V., The Netherlands] for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b. The comparator vaccine (control) was INFANRIX hexa (GlaxoSmithKline Biologics S.A., Rixensart, Belgium) (DTaP3-IPV-HepB/Hib) in European studies and PENTACEL (DTaP5-IPV/Hib) (Sanofi Pasteur, Swiftwater, PA) in US studies. Methods: Data from 6 studies were integrated and analyzed to provide a comprehensive safety profile. Numbers and proportions of subjects with adverse events (AEs) were summarized by treatment group. Group differences in proportion of AEs were calculated. Results: Among the DTaP5-HB-IPV-Hib (N = 5223) and 2295 control (N = 2295) groups, solicited injection-site and systemic AEs were very common. Serious AEs were reported by 3.9% of DTaP5-HB-IPV-Hib and 3.7% of control subjects. Vaccine-related serious AEs occurred infrequently, 0.2% for both groups. Most AEs were mild-...
Source: The Pediatric Infectious Disease Journal - Category: Infectious Diseases Tags: Vaccine Reports Source Type: research