CLINICAL DEVELOPMENT OF A COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS, AND HEPATITIS-B VACCINE IN ITALY

In Italy, oral polio vaccine and diphtheria and tetanus (DT) and hepat itis B (HB) vaccinations are required by law. At present, infants rece ive DT and HB by two separate intramuscular injections during one visi t, and most receive an additional injection of acellular pertussis vac cine at the same time. Although simultaneous administration of the vac cines has the advantage of only one medical visit, it is lime-consumin g for staff, very expensive, painful to the infants, and stressful for parents. A much better solution would be to administer a ready-to-use mixture containing all the vaccines, provided that this combination v accine had good local and systemic safety profiles and clinical and im munologic efficacy. To evaluate such a combination vaccine in healthy infants at 3, 5, and 11 and at 2, 4, and 6 months of age, a multicente r clinical study is underway in Italy.