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Table 2 Efficacy of antipyretic prophylaxis in preventing fever within 4 days of vaccination

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

ITT analysis population

PP analysis population

 

Prophylaxis group

Control group

Efficacy*

Prophylaxis group

Control group

Efficacy*

 

% (n/N)

% (n/N)

% (95% CI)

% (n/N)

% (n/N)

% (95% CI)

Fever ≥38°C

Fever ≥38°C

Infant series

43.0 (43/100)

75.4 (95/126)

43.0 (17.4, 61.2)

36.3 (29/80)

75.9 (82/108)

52.3 (26.3, 69.9)

Toddler dose

53.7 (58/108)

63.9 (76/119)

15.9 (−19.9, 41.3)

51.6 (49/95)

61.5 (67/109)

16.1 (−23.1, 43.2)

Fever >39°C

Fever >39°C

Dose 1

0

4.0 (5/124)

100.0 (−17.7, 100)

0

4.6 (5/109)

100.0 (−22.6, 100.0)

Dose 2

0

1.8 (2/112)

100.0 (NA)

0

2.0 (2/100)

100.0 (NA)

Dose 3

1.0 (1/102)

1.9 (2/103)

49.5 (NA)

1.1 (1/87)

1.1 (1/91)

−4.6 (NA)

Toddler dose

4.6 (4/87)

13.1 (13/99)

65.0 (−13.3, 91.7)

2.6 (2/78)

12.2 (11/90)

79.0 (3.9, 97.7)

  1. *Efficacy is 1 − relative risk (prophylaxis group relative to control group). Confidence interval (CI) is computed using exact methods conditional upon the number of subjects having reported the specific fever. No CI was computed when <5 subjects reported a febrile reaction. Differences between groups is significant if lower limit of 95% CI >1 for computed efficacy and similar if 95% CI includes 1. ITT intent-to-treat population, PP per-protocol population, N number of subjects included in the analysis, n number of subjects with the specified degree of fever, NA not applicable.
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BMC Pediatrics

ISSN: 1471-2431

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