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Table 3 Percentage of subjects (with 95% confidence intervals) reporting solicited systemic symptoms within 7 days after the first and after the second dose of H1N1 vaccine in adults aged 18 to 60 years and in adults >60 years

From: Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18–60 and >60 years: a randomized trial

Symptom

Intensity

Group A Vaccinated on Day 0 and Day 21

Group B Vaccinated on Day 0 and Day 182

Dose 1% (95% CI)

18-60 years N = 92

>60 years N = 90

18-60 years N = 70

>60 years N = 52

Fatigue

Any

43.5

28.9

38.6

34.6

(33.2-54.2)

(19.8-39.4)

(27.2-51.0)

(22.0-49.1)

Grade 3*

0.0

0.0

1.4

0.0

(0.0-3.9)

(0.0-4.0)

(0.0-7.7)

(0.0-6.8)

Headache

Any

37.0

22.2

31.4

17.3

(27.1-47.7)

(14.1-32.2)

(20.9-43.6)

(8.2-30.3)

Grade 3*

0.0

1.1

1.4

0.0

(0.0-3.9)

(0.0-6.0)

(0.0-7.7)

(0.0-6.8)

Joint pain at other location

Any

22.8

21.1

14.3

15.4

(14.7-32.8)

(13.2-31.0)

(7.1-24.7)

(6.9-28.1)

Grade 3*

0.0

0.0

0.0

0.0

(0.0-3.9)

(0.0-4.0)

(0.0-5.1)

(0.0-6.8)

Muscle aches

Any

46.7

28.9

32.9

28.8

(36.3-57.4)

(19.8-39.4)

(22.1-45.1)

(17.1-43.1)

Grade 3*

0.0

0.0

0.0

1.9

(0.0-3.9)

(0.0-4.0)

(0.0-5.1)

(0.0-10.3)

Shivering

Any

18.5

13.3

20.0

11.5

(11.1-27.9)

(7.1-22.1)

(11.4-31.3)

(4.4-23.4)

Grade 3*

0.0

1.1

0.0

0.0

(0.0-3.9)

(0.0-6.0)

(0.0-5.1)

(0.0-6.8)

Sweating

Any

13.0

11.1

10.0

13.5

(6.9-21.7)

(5.5-19.5)

(4.1-19.5)

(5.6-25.8)

Grade 3*

1.1

0.0

0.0

0.0

(0.0-5.9)

(0.0-4.0)

(0.0-5.1)

(0.0-6.8)

Fever (Axillary temp)

Any

1.1

1.1

2.9

1.9

(0.0-5.9)

(0.0-6.0)

(0.3-9.9)

(0.0-10.3)

≥39.0 to ≤40°C

0.0

0.0

0.0

0.0

(0.0-3.9)

(0.0-4.0)

(0.0-5.1)

(0.0-6.8)

  

Dose 2% (95% CI)

18-60 years N = 91

>60 years N = 85

18-60 years N = 60

>60 years N = 45

Fatigue

Any

53.8

31.8

51.7

29.5

(43.1-64.4)

(22.1-42.8)

(38.4-64.8)

(16.8-45.2)

Grade 3*

3.3

1.2

3.3

0.0

(0.7-9.3)

(0.0-6.4)

(0.4-11.5)

(0.0-8.0)

Headache

Any

45.1

22.4

35.0

25.0

(34.6-55.8)

(14.0-32.7)

(23.1-48.4)

(13.2-40.3)

Grade 3*

1.1

1.2

5.0

0.0

(0.0-6.0)

(0.0-6.4)

(1.0-13.9)

(0.0-8.0)

Joint pain at other location

Any

19.8

24.7

26.7

27.3

(12.2-29.4)

(16.0-35.3)

(16.1-39.7)

(15.0-42.8)

Grade 3*

0.0

0.0

0.0

0.0

(0.0-4.0)

(0.0-4.2)

(0.0-6.0)

(0.0-8.0)

Muscle aches

Any

42.9

29.4

51.7

34.1

(32.5-53.7)

(20.0-40.3)

(38.4-64.8)

(20.5-49.9)

Grade 3*

0.0

0.0

1.7

0.0

(0.0-4.0)

(0.0-4.2)

(0.0-8.9)

(0.0-8.0)

Shivering

Any

28.6

15.3

18.3

15.9

(19.6-39.0)

(8.4-24.7)

(9.5-30.4)

(6.6-30.1)

Grade 3*

1.1

1.2

0.0

0.0

(0.0-6.0)

(0.0-6.4)

(0.0-6.0)

(0.0-8.0)

Sweating

Any

20.9

16.5

13.3

9.1

(13.1-30.7)

(9.3-26.1)

(5.9-24.6)

(2.5-21.7)

Grade 3*

1.1

0.0

0.0

0.0

(0.0-6.0)

(0.0-4.2)

(0.0-6.0)

(0.0-8.0)

Fever (Axillary temp)

Any

6.6

5.9

1.7

0.0

(2.5-13.8)

(1.9-13.2)

(0.0-8.9)

(0.0-8.0)

≥39.0 to ≤40°C

0.0

2.4

0.0

0.0

(0.0-4.0)

(0.3-8.2)

(0.0-6.0)

(0.0-8.0)

  1. *Grade 3 events were defined as events that prevent normal everyday activities (inability to attend/do work), or that require intervention of a physician/healthcare provider.