SAFETY AND IMMUNOGENICITY OF AN INACTIVATED SUBUNIT INFLUENZA-VIRUS VACCINE COMBINED WITH MF59 ADJUVANT EMULSION IN ELDERLY SUBJECTS, IMMUNIZED FOR 3 CONSECUTIVE INFLUENZA SEASONS

A clinical trial to evaluate the safety and tolerability of a new infl uenza adjuvanted vaccine (FLUAD(R), Chiron Vaccines), compared with a conventional non adjuvanted influenza vaccine, was conducted in elderl y ambulatory patients. Subjects were vaccinated with one dose of eithe r vaccine each year for three consecutive years; 92 subjects received the first immunization, 74 subjects received the second and 67 subject s received the third. The primary objective of this study was to evalu ate the safely of repetitive injections of the adjuvanted vaccine in e lderly subjects. There were no reports of any vaccine-related serious adverse event or of safety concerns related to study vaccines after th e first, second or third immunization. The adjuvanted Vaccine induced more local reactions than the conventional vaccine; however, the react ions were normally mild and limited to the first 2-3 days after immuni zation. No statistically significant difference between groups in syst emic postimmunization reactions was reported except for a mild, transi ent malaise after the first immunization. Compared with the first immu nization, no increase in postimmunization reactions was seen after the second and third immunizations. Despite the small sample size of the trial, which was not powered to test immunogenicity differences, the a ntibody response was tested and resulted higher in the adjuvanted vacc ine recipients, not only against the current season's vaccine strains, but also against heterologous vaccine strains. (C) 1998 Elsevier Scie nce Ltd. All rights reserved.