Efficacy of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine in US children aged 18-59 months. Haemophilus Influenzae Vaccine Efficacy Study Group.

Vaccines prepared from the polyribosylribitol phosphate (PRP) capsule of Haemophilus influenzae b (Hib) have not consistently shown good efficacy in protecting children aged over 18 months from invasive Hib disease. To evaluate the efficacy of conjugate-PRP vaccines in this age-group, and to compare their effect with that of PRP vaccines, a post-marketing case-control study was conducted among 10,400,000 persons. Between Oct 1, 1988, and Feb 28, 1990, 75 patients with Hib disease and 161 control children between 18 and 60 months of age were enrolled. To minimise potentially confounding socioeconomic variables, controls were selected either from among patients' classmates at their day-care centre or from among family acquaintances. 9 of the 75 patients had received the diphtheria toxoid conjugate Hib vaccine more than 2 weeks before onset of illness. After adjusting for age and household crowding, the efficacy of PRP Hib vaccine was 64% (95% Cl = -20,89) and efficacy of the diphtheria toxoid conjugate Hib vaccine was 74% (95% Cl = 30,90). The study shows that the protective efficacy of this conjugate vaccine is less than ideal and highlights the need for additional post-licensing studies to confirm and expand understanding of the efficacy of these new products.