The efficacy of the Haemophilus influenzae type b (Hib) polyribose phosphate vaccine was evaluated in a population of 120,000 children from 23 through 71 months of age in the Kaiser Permanente Medical Care Program (KPMCP) in Northern California over the 2-year period from June 1, 1985, through May 31, 1987. Approximately 37% of the population were vaccinated by the end of the first year and 60% were vaccinated by the end of the second year. There were 35 cases of Hib disease, 4 of whom were vaccine failures. Cases of Hib disease were identified by multiple modality case ascertainment, consisting of: (1) active surveillance in KPMCP microbiology laboratories; (2) active surveillance on KPMCP pediatric wards by a study physician; (3) retrospective review of computer-stored hospital discharge diagnoses; and (4) a review of all hospitalizations outside the health plan. The medical records of cases, matched controls and a random sample of the population were reviewed to obtain information on vaccination and related variables. Efficacy was evaluated using two complementary methods. In a retrospective surveillance approach, efficacy was estimated to be 68% (95% confidence limits of 4, 89%). In a matched case-control analysis, efficacy was estimated to be 69% (95% confidence limits of -13, 91%). Adjustment for day care attendance and parental occupation slightly reduced the efficacy estimate. Other possible confounders including race, parental education and number of siblings were considered. Four cases of Hib disease were observed within 1 week following receipt of vaccine and before the time when immunity could have developed. There are several plausible explanations for the occurrence of these early cases including the possibility of chance alone.(ABSTRACT TRUNCATED AT 250 WORDS)