A multicenter, randomized, double-blind study was undertaken in 2342 i
nfants to evaluate the safety and immunogenicity of 13 acellular and 2
whole cell pertussis vaccines combined with diphtheria and tetanus to
xoids. Vaccines were administered to infants 2, 4, and 6 months of age
. Sera were obtained before the first vaccination (age 2 months) and 1
month after the third vaccination (age 7 months). All of the acellula
r vaccines produced significant increases in antibody for included ant
igens; mean antibody levels often exceeded those obtained with the ref
erence whole cell vaccine. The vaccines were well-tolerated. All acell
ular vaccines were associated with significantly fewer adverse reactio
ns than the control whole cell vaccine.