Immunogenicity and reactogenicity of a combined fully liquid DTPw–HepB–Hib pentavalent vaccine in healthy infants: no clinically relevant impact of a birth dose of hepatitis B vaccine

SummaryObjectivesIn this open-label, non-randomized phase II study, the safety and immunogenicity of a fully liquid diphtheria–tetanus–whole cell pertussis–hepatitis B–Haemophilus influenzae type b (DTPw–HepB–Hib) combination vaccine (Quinvaxem®) were assessed in infants who had or had not received a birth dose of hepatitis B (HepB) vaccine.Study designTwo groups of infants, ‘HepB at birth’ (n=110) and ‘no HepB at birth’ (n=108), were enrolled and received a primary vaccination course using a 2–4–6 months schedule.ResultsSeroprotection/seroconversion rates of >95% were achieved against all antigens included in the combination vaccine for both study groups. Although significantly higher anti-hepatitis B virus (p