Skip to main content

Table 2 Incidence (% [95% CI]) of solicited local and general symptoms during the 4 days following primary (overall/dose) and booster vaccination (Total vaccinated cohort)

From: Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

  Primary doses Booster dose
Solicited symptom DTPw-HBV/Hib
(N = 1274)
Tritanrix™-HBV/Hib
(N = 422)
DTPw-HBV/Hib
(N = 113)
Tritanrix™-HBV/Hib
(N = 34)
Pain     
   Any 73.4 (70.9, 75.8) 69.4 (64.8, 73.8) 90.3 (83.2, 95.0) 79.4 (62.1, 91.3)
   Grade 3 21.8 (19.6, 24.2)§ 15.4 (12.1, 19.2)§ 43.4 (34.1, 53.0) 23.5 (10.7, 41.2)
   MA 0.5 (0.2, 1.1) 0.5 (0.1, 1.7) 0 (0.0, 3.2) 0 (0.0, 10.3)
Redness     
   Any 53.1 (50.4, 55.9)§ 44.1 (39.3, 49.0)§ 48.7 (39.2, 58.3) 44.1 (27.2, 62.1)
   > 20 mm 17.3 (15.2, 19.5) 12.8 (9.8, 16.4) 14.2 (8.3, 22.0) 11.8 (3.3, 27.5)
   MA 0.6 (0.3, 1.2) 0 (0.0, 0.9) 0 (0.0, 3.2) 0 (0.0, 10.3)
Swelling     
   Any 51.1 (48.3, 53.9) 46.4 (41.6, 51.3) 64.6 (55.0, 73.4) 38.2 (22.2, 56.4)
   > 20 mm 21.7 (19.4, 24.0) 23.2 (19.3, 27.6) 28.3 (20.2, 37.6) 17.6 (6.8, 34.5)
   MA 0.7 (0.3, 1.3) 0.2 (0.0, 1.3) 0.9 (0.0, 4.8) 0 (0.0, 10.3)
Drowsiness     
   Any 44.3 (41.6, 47.1) 44.1 (39.3, 49.0) 39.8 (30.7, 49.5) 17.6 (6.8, 34.5)
   Grade 3 1.5 (0.9, 2.3) 0.9 (0.3, 2.4) 2.7 (0.6, 7.6) 0 (0.0, 10.3)
   MA 0.4 (0.1, 0.9) 0.2 (0.0, 1.3) 0 (0.0, 3.2) 0 (0.0, 10.3)
Rectal temperature     
   Any 56.9 (54.1, 59.6)§ 46.7 (41.8, 51.6)§ 70.8 (61.5, 79.0) 58.8 (40.7, 75.4)
   > 38.0°C 56.9 (54.1, 59.6)§ 46.7 (41.8, 51.6)§ 38.1 (29.1, 47.7) 14.7 (5.0, 31.1)
   > 38.5°C 19.6 (17.5, 21.9) 17.5 (14.0, 21.5) 21.2 (14.1, 29.9) 5.9 (0.7, 19.7)
   > 39.0°C 6.9 (5.6, 8.4) 5.0 (3.1, 7.5) 1.8 (0.2, 6.2) 2.9 (0.1, 15.3)
   > 39.5°C 2.8 (2.0, 3.9) 3.1 (1.7, 5.2) 0.9 (0.0, 4.8) 0.0 (0.0, 10.3)
   > 40.0°C 0.5 (0.2, 1.0) 0.7 (0.1, 2.1) 0.0 (0.0, 3.2) 0.0 (0.0, 10.3)
   MA 1.2 (0.7, 1.9) 0.5 (0.1, 1.7) 0.0 (0.0, 3.2) 0.0 (0.0, 10.3)
Irritability     
   Any 67.0 (64.4, 69.6) 65.2 (60.4, 69.7) 71.7 (62.4, 79.8) 47.1 (29.8, 64.9)
   Grade 3 5.0 (3.9, 6.4) 6.6 (4.5, 9.4) 9.7 (5.0, 16.8) 0 (0.0, 10.3)
   MA 0.7 (0.3, 1.3) 0.7 (0.1, 2.1) 0 (0.0, 3.2) 0 (0.0, 10.3)
Loss of appetite     
   Any 29.9 (27.4, 32.5) 26.1 (21.9, 30.5) 42.5 (33.2, 52.1) 29.4 (15.1, 47.5)
   Grade 3 0.8 (0.4, 1.4) 0.5 (0.1, 1.7) 4.4 (1.5, 10.0) 0 (0.0, 10.3)
   MA 0.3 (0.1, 0.8) 0.2 (0.0, 1.3) 0 (0.0, 3.2) 0 (0.0, 10.3)
  1. N = number of doses; MA = medical advice sought for the symptom; § non-overlapping CI