The immunogenicity and safety of a new combined diphtheria, tetanus and poliomyelitis booster vaccine (Td-eIPV)

In view of the continuing risk of contracting tetanus, diphtheria and polio myelitis, and the well-documented decline in immunity with time, the need f or booster vaccinations is substantial, The immunogenicity and safety of a new combined booster vaccine against tetanus, diphtheria and poliomyelitis (REVAXIS(TM)) developed by Pasteur Merieux Connaught (Lyon, France) were ev aluated in four clinical studies. This vaccine (Td-eIPV) combines an adsorb ed tetanus toroid and low-dose diphtheria toroid vaccine (Td) with an enhan ced, inactivated polio vaccine against poliovirus types 1, 2 and 3 (eIPV), In 256 healthy young adults, a single dose of Td-eIPV was shown to be immun ogenic, eliciting antibody levels considered protective against disease for each vaccine component in 2 99.6% of the subjects, In 112 healthy older su bjects (> 40 years of age), two doses of Td-eIPV elicited seroprotective le vels of antibodies in 94% of the subjects for diphtheria, and in all subjec ts for tetanus and poliovirus types 1, 2 and 3, Safety data from all 368 su bjects, as well as 31 phase I volunteers and 1,742 subjects included in a s afety study, reveal that the vaccine is safe, Most reactions were predictab le, temporary and mild. There was no evidence that the vaccine was associat ed with any clinically serious event or modification of clinical laboratory parameters. The data reviewed here show that Td-eIPV is immunogenic and sa fe when administered as a booster vaccination in healthy adults of all ages .