Italy was the first industrialized country to introduce mass vaccination against hepatitis B. Following the collection of epidemiological data on age-specific incidence rates of infection, a law was issued in 1991 which established mandatory immunization of neonates and 12-year-old adolescents. This strategy will lead to the protection of all subjects aged 0-24 years within 12 years and to the elimination of circulation of hepatitis B virus (HBV) in a few decades. The first data on compliance with vaccination, both in infants and in adolescents, indicate the success of the programme, which was helped by good vaccination delivery services and awareness of the risks of hepatitis B both by physicians and the public. A multi-centre study on protective antibody level and kinetics over time is in progress. Preliminary results show an excellent response to vaccination. High-risk strategies will continue by actively offering HBV vaccination free of charge to all those exposed to infection via occupation or life-style. The Italian policy of universal vaccination against HBV can therefore be regarded as a model for the introduction of mass immunization into other countries.