In preparation for a field trial of an Haemophilus influenzae type b conjugate vaccine in the Western Region of The Gambia, a 3-year prospective study was undertaken to determine the incidence of Hib disease and the vaccination status of affected children. One hundred and eighty-two children with invasive Hib disease were found; 141 (77%) had meningitis, 31 (17%) pneumonia and 10 (6%) other forms of invasive disease. The estimated annual incidence rates for all invasive Hib diseases were 274 and 73 per 100,000 in children aged < 1 and < 5 years, respectively. For meningitis, the rate was 222 per 100,000 per year in children aged < 1 year. Children with meningitis were significantly younger than those with pneumonia (median age 7 months, interquartile range [IQR] 5-9, vs 12 months, IQR 6-15 (P = 0.002)) and younger than those with other forms of Hib disease. Of 142 children for whom vaccination status was known, 18 had received no DPT, 36 had received one, 40 had received two and 48 had received three doses. This study confirmed the high incidence of systemic Hib disease among Gambian children and the need to vaccinate at an early age. It provided the background epidemiological data required for the successful planning of an Hib vaccine trial which is now in progress.