The time relationship between DTP immunization and infantile spasms (I
S) onset was examined using three models-association, temporal shift,
and no-effect-and the case/control data from the National Childhood En
cephalopathy Study (NCES). Infantile spasms cases classified as being
previously abnormal (e.g. tuberous sclerosis complex patients) showed
a no-effect relationship, whereas those classified as previously norma
l suggested a Jit to the temporal shift model, i.e. no increase in num
ber-of cases but a shortening of time to onset of seizure. No data fit
the association model. Analyses for vaccine complications should exam
ine for temporal changes (i.e. temporal shift) in addition to increase
d risks. (C) 1997 Elsevier Science Ltd. All rights reserved.