Risk of serious acute neurological illness after immunization with diphtheria-tetanus-pertussis vaccine. A population-based case-control study.
OBJECTIVE
To evaluate the association between serious acute neurological illness and receipt of whole-cell pertussis vaccine, given as diphtheria-tetanus-pertussis (DTP) vaccine.


METHODS
Population-based case-control study.


METHODS
Outpatient and inpatient hospital settings, physician practices, and the general population in Washington and Oregon states.


METHODS
A total of 424 confirmed cases of neurological illness were identified prospectively during a 12-month period by statewide active surveillance from the population of 218,000 children 1 to 24 months of age living in Washington and Oregon (estimated 368,000 DTP immunizations given). Each case child was matched to two population control children by birth date (+/- 5 days), gender, and county of birth. Written immunization records were used to determine whether illness occurred within 7 days of immunization in case children, or within 7 days of the same reference date in control children, thus qualifying as exposed.


METHODS
Outpatient and inpatient cases of complex febrile seizures, seizures without fever, infantile spasms, and acute encephalitis/encephalopathy confirmed by an expert panel masked to immunization history.


RESULTS
The estimated odds ratio (OR) for onset of serious acute neurological illness within 7 days for young children exposed to DTP vaccine was 1.1 (95% confidence interval [CI], 0.6 to 2.0). When the analysis was restricted to children with encephalopathy or complicated seizures and adjusted for factors possibly affecting vaccine administration, the OR was 3.6 (95% CI, 0.8 to 15.2). Odds ratios for specific study diagnoses varied, but all CIs included 1. No elevated risk was observed for the largest group of illnesses studied, nonfebrile seizures (OR, 0.5; 95% CI, 0.2 to 1.5).


CONCLUSIONS
This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the 7 days after DTP vaccine exposure for young children.
Gale
J L
JL
Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle 98195.
Thapa
P B
PB
Wassilak
S G
SG
Bobo
J K
JK
Mendelman
P M
PM
Foy
H M
HM
D000208:Acute Disease; D001927:Brain Diseases / Q000453:epidemiology / Q000209:etiology; D016022:Case-Control Studies; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects*; D004673:Encephalomyelitis, Acute Disseminated / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009922:Oregon / Q000453:epidemiology; D010567:Pertussis Vaccine / Q000009:adverse effects; D011159:Population Surveillance; D012306:Risk; D012640:Seizures / Q000453:epidemiology / Q000209:etiology*; D013035:Spasm / Q000453:epidemiology / Q000209:etiology*; D013223:Statistics as Topic; D014861:Washington / Q000453:epidemiology
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D010567:Pertussis Vaccine