Table 1.

Percentage of Subjects With Solicited Adverse Reactions During the 15-Day Follow-Up Period After Immunization

Adverse ReactionGradeVaccine Group
dTpa (n= 448)
(95% CI)
Td (n = 60)
(95% CI)
pa (n = 59)
(95% CI)
Local reactions
 PainAny79.0 (75.0–82.7)83.3 (71.5–91.7)67.8 (54.4–79.4)
Severe*3.8 (2.2–6.0)10.0 (3.8–20.5)8.5 (2.8–18.7)
 RednessAny33.0 (28.7–37.6)53.3 (40.0–66.3)8.5 (2.8–18.7)
≥50 mm5.8 (3.8–8.4)16.7 (8.3–28.5) .0 (.0–6.1)
 SwellingAny35.0 (30.6–39.7)46.7 (33.7–60.0)15.3 (7.2–27.0)
≥50 mm7.8 (5.5–10.7)10.0 (3.8–20.5)1.7 (.0–9.1)
Systemic reactions
 FatigueAny56.2 (51.5–60.9)50.0 (36.8–63.2)40.7 (28.1–54.3)
Severe2.9 (1.6–4.9)1.7 (.0–8.9) .0 (.0–6.1)
 HeadacheAny51.3 (46.6–56.1)51.7 (38.4–64.8)35.6 (23.6–49.1)
Severe3.6 (2.1–5.7)1.7 (.0–8.9)5.1 (1.1–14.2)
 Fever≥37.5°C8.9 (6.5–12.0)8.3 (2.8–18.4)5.1 (1.1–14.2)
≥39.1°C .4 (.1–1.6) .0 (.0–.6) .0 (.0–6.1)
  • * Severe indicates an adverse event that prevents normal daily activities and needs medical advice.

  • P < .001 between dTpa and Td groups.