Adverse reactions to the preschool (fifth) dose of adsorbed
diphtheria-pertussis-tetanus vaccine in Canadian children.
Scheifele DW, Meekison W, Grace M, Barreto L, Carter AO, Mitchell L, Farley
J.
Vaccine Evaluation Center, British Columbia's Children's Hospital, Vancouver.
OBJECTIVE: To quantify accurately the rate of adverse reactions after the
preschool (fifth) dose of adsorbed diphtheria toxoid-pertussis vaccine-tetanus
toxoid (DPT) vaccine and to test the hypothesis that large local reactions are
attributable to the diphtheria toxoid. DESIGN: Double-blind randomized
controlled trial. SETTING: Suburban community public health unit. PARTICIPANTS:
Healthy children 4 to 5 years of age with a history of having received four
doses of adsorbed DPT vaccine. INTERVENTIONS: Subjects were given either the
standard DPT vaccine (with 25 Lf units of diphtheria toxoid) or a modified DPT
vaccine (with 10 Lf units of diphtheria toxoid). They were assessed 24 hours
later by a nurse. Serum samples obtained before vaccination were tested for
diphtheria and tetanus antitoxin levels by means of neutralization assay and
enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES: Rates of large local
reactions (an area of redness or swelling or both of 5 cm or greater) 24 hours
after vaccination in the two groups. Relation between serum antitoxin levels
before vaccination and the rate of large local reactions in each group. RESULTS:
Of the 250 subjects enrolled 124 received the standard vaccine and 126 the
modified one. Large local reactions occurred in 71% of the subjects receiving
the standard vaccine and 52% of those receiving the modified one (p less than
0.01). In the former group large erythematous reactions occurred significantly
more often in those with an elevated prevaccination diphtheria antitoxin level
than in those without an elevated level; no relation was found between such
reactions and the prevaccination tetanus antitoxin level. Reduced arm movement
was evident in 45% of the children in the two groups. Few had systemic adverse
reactions. CONCLUSIONS: Large local reactions occur frequently after the
preschool administration of the DPT vaccine. These reactions are uncomfortable
but not serious. They result in part from the large amount of diphtheria toxoid
in the standard DPT vaccine.
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