In a prospective nationwide laboratory-based surveillance study of all invasive bacterial and fungal infections among children < 16 years of age, 2,836 clinical cases were registered during the 5-year period 1985-1989. Of these cases, 136 were polymicrobial. During the study period, nationwide administration of Haemophilus influenzae type b conjugate vaccine reduced the incidence rates of invasive infection caused by this organism. The most common clinical diagnosis (48% of cases) was bacteremia without an identified focus of infection. The age-specific annual incidence rates of all invasive infections in children < or = 15 years of age, in children < or = 4 years of age, in children < or = 1 year of age, and in children < or = 28 days of age were 55.8, 141.4, 272.7, and 2,749.0 cases/100,000 person-years, respectively. Thirty percent of the children in the study had an underlying condition predisposing to infection. The case-fatality rate was 4.1% for all cases of invasive infection.