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Table 4 Systemic events within 4 days of PCV-7 and DTPa-HBV-IPV/Hib vaccination –safety population

From: An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine

Systemic event

Dose

Prophylaxis group % (n/N)

Control group % (n/N)

p-value*

Fever

Dose 1

9.3 (11/118)

35.8 (48/134)

<0.001

≥38°C to ≤39°C

Dose 2

19.7 (24/122)

43.7 (55/126)

0.000

 

Dose 3

19.3 (21/109)

45.6 (52/114)

0.000

 

Toddler dose

51.5 (53/103)

60.0 (69/115)

0.221

>39°C to ≤40°C

Dose 1

0

4.0 (5/124)

0.061

 

Dose 2

0

1.8 (2/112)

0.238

 

Dose 3

1.0 (1/102)

1.9 (2/103)

>0.99

 

Toddler dose

4.6 (4/87)

13.1 (13/99)

0.072

>40°C

Toddler dose

0

1.1 (1/95)

>0.99

Rash

Dose 1

17.6 (21/119)

17.1 (22/129)

>0.99

 

Dose 2

6.8 (8/118)

15.7 (19/121)

0.040

 

Dose 3

12.7 (14/110)

22.4 (24/107)

0.074

 

Toddler dose

13.3 (12/90)

23.6 (25/106)

0.098

Irritability

Dose 1

47.2 (59/125)

62.1 (87/140)

0.019

 

Dose 2

42.2 (54/128)

58.5 (76/130)

0.013

 

Dose 3

39.7 (48/121)

50.0 (59/118)

0.120

 

Toddler dose

48.2 (53/110)

60.5 (75/124)

0.066

Drowsiness

Dose 1

50.4 (65/129)

64.7 (90/139)

0.019

 

Dose 2

46.5 (59/127)

58.3 (74/127)

0.078

 

Dose 3

36.4 (43/118)

45.6 (52/114)

0.182

 

Toddler dose

43.5 (47/108)

50.4 (59/117)

0.350

Decreased appetite

Dose 1

30.3 (37/122)

40.0 (54/135)

0.118

 

Dose 2

26.6 (33/124)

42.7 (53/124)

0.011

 

Dose 3

23.0 (26/113)

33.6 (37/110)

0.101

 

Toddler dose

38.2 (39/102)

45.2 (52/115)

0.336

Persistent inconsolable crying

Dose 1

9.5 (11/116)

20.0 (26/130)

0.031

Dose 2

9.3 (11/118)

15.8 (19/120)

0.171

Dose 3

14.0 (15/107)

15.3 (17/111)

0.849

Toddler dose

7.8 (7/90)

17.1 (18/105)

0.056

Decreased activity

Dose 1

41.6 (52/125)

46.3 (63/136)

0.457

 

Dose 2

31.0 (39/126)

48.0 (60/125)

0.007

 

Dose 3

23.3 (27/116)

40.0 (46/115)

0.007

 

Toddler dose

29.0 (29/100)

48.3 (56/116)

0.005

  1. n = number of subjects experiencing the event. N = Number of subjects reporting “yes” for at least 1 day or “no” for all days.
  2. *Fisher exact test, 2-sided.
  3. One severe event occurred after toddler dose only.