In 1998, a series of regional cluster surveys (the ICONA Study) was conducted simultaneously in 19 out of the 20 regions in Italy to estimate the mandatory immunization coverage of children aged 12-24 months with oral poliovirus (OPV), diphtheria-tetanus (DT) and viral hepatitis B (HBV) vaccines, as well as optional immunization coverage with pertussis, measles and Haemophilus influenzae b (Hib) vaccines. The study children were born in 1996 and selected from birth registries using the Expanded Programme of Immunization (EPI) cluster sampling technique. Interviews with parents were conducted to determine each child's immunization status and the reasons for any missed or delayed vaccinations. The study population comprised 4310 children aged 12-24 months. Coverage for both mandatory and optional vaccinations differed by region. The overall coverage for mandatory vaccines (OPV, DT and HBV) exceeded 94%, but only 79% had been vaccinated in accord with the recommended schedule (i.e. during the first year of life). Immunization coverage for pertussis increased from 40% (1993 survey) to 88%, but measles coverage (56%) remained inadequate for controlling the disease; Hib coverage was 20%. These results confirm that in Italy the coverage of only mandatory immunizations is satisfactory. Pertussis immunization coverage has improved dramatically since the introduction of acellular vaccines. A greater effort to educate parents and physicians is still needed to improve the coverage of optional vaccinations in all regions.