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Table 4 Comparisons of proportion of infants with a worst ear diagnosis* of each form of otitis media, by vaccine group and age (months)

From: Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

Dx [worst*]

Age (mo)

_PPP

 

_SSS

 

SSSP

 

SSSP vs _PPP

  

SSSP vs _SSS

  

_PPP vs _SSS

  
 

%

95%CI

%

95%CI

%

95%CI

%

95%CI

p

%

95%CI

p

%

95%CI

p

Normal

 1**

57

(49, 65)

59

(50, 67)

54

(46, 63)

−3

(−14, 9)

0.72

−5

(−16, 7)

0.47

−2

(− 13, 10)

0.81

 2**

40

(32, 49)

48

(39, 57)

40

(32, 49)

0

(−12, 11)

1.0

−8

(−20, 4)

0.18

−8

(− 20, 4)

0.22

 4

20

(14, 28)

20

(13, 28)

16

(10, 23)

−4

(−13, 5)

0.43

−4

(−13, 5)

0.43

0

(−9, 10)

1.0

 6

10

(6, 17)

14

(8, 21)

14

(9, 21)

4

(− 4, 12)

0.46

0

(−8, 9)

1.0

−3

(−11, 4)

0.45

 7

9

(5, 16)

14

(9, 22)

10

(5, 16)

0

(−7, 7)

1.0

−5

(−13, 3)

0.26

−5

(−13, 3)

0.26

OM

1**

43

(35, 51)

41

(33, 50)

46

(37, 54)

3

(−9, 14)

0.72

5

(−7, 16)

0.47

2

(−10, 13)

0.81

2**

60

(51, 68)

52

(43, 61)

59

(50, 67)

−1

(−13, 10)

1.0

7

(−5, 19)

0.18

8

(−4, 20)

0.22

OME

 4

38

(30, 47)

48

(39, 57)

44

(36, 53)

6

(−6, 18)

0.43

−3

(−15, 9)

0.43

−9

(−21, 2)

1.0

 6

34

(26, 43)

38

(29, 47)

40

(32, 49)

6

(−6, 17)

0.46

2

(−9, 14)

1.0

−4

(−15, 8)

0.45

 7

30

(22, 38)

34

(26, 43)

34

(26, 42)

4

(−7, 15)

1.0

0

(−12, 11)

0.26

−4

(−15, 7)

0.26

AOMwoP

 4

39

(31, 48)

32

(24, 40)

37

(29, 46)

−2

(−14, 9)

0.80

5

(−6, 16)

0.44

7

(−4, 19)

0.25

 6

43

(34, 52)

40

(32, 49)

39

(30, 47)

−4

(−16, 7)

0.54

− 1

(− 13, 10)

0.90

3

(−9, 15)

0.71

 7

49

(40, 57)

42

(34, 51)

49

(41, 58)

1

(−11, 13)

1.0

7

(−5, 19)

0.27

6

(−6, 18)

0.33

AOMwiP

 4

3

(1, 7)

0

(0, 3)

2

(0, 6)

−1

(−4, 3)

1.0

2

(0, 5)

0.25

3

(0, 6)

0.12

 6

10

(5, 16)

4

(1, 9)

5

(2, 10)

−4

(−11, 2)

0.24

1

(−4, 6)

0.77

6

(0, 12)

0.086

 7

7

(3, 12)

6

(3, 12)

5

(2, 10)

−1

(−7, 4)

0.80

−1

(−6, 5)

0.80

0

(−5, 6)

1.0

CSOM

 4

0

(0, 3)

1

(0, 4)

1

(0, 4)

1

(−1, 2)

0.49

0

(−2, 2)

1.0

−1

(−2, 1)

0.49

 6

3

(1, 7)

5

(2, 10)

2

(0, 6)

−1

(−5, 3)

1.0

−2

(−7, 2)

0.33

−2

(−6, 3)

0.53

 7

6

(3, 11)

3

(1, 8)

2

(0, 6)

−4

(−8, 1)

0.22

−1

(−5, 3)

0.72

3

(−2, 8)

0.38

Any Supp#

 4

42

(34, 51)

33

(25, 41)

40

(31, 49)

−2

(−14, 10)

0.80

7

(−4, 19)

0.25

9

(−2, 21)

0.13

 6

56

(47, 64)

48

(40, 57)

46

(37, 55)

−10

(−22, 2)

0.14

−3

(− 15, 9)

0.71

7

(−5, 19)

0.27

 7

61

(52, 69)

52

(43, 60)

57

(48, 65)

−4

(−16, 7)

0.54

5

(−7, 17)

0.46

9

(−2, 21)

0.14

Any TMP##

 4

3

(1, 7)

1

(0, 4)

3

(1, 8)

0

(−4, 4)

1.0

2

(−1, 6)

0.37

2

(−1, 5)

0.37

 6

13

(8, 19)

8

(4, 15)

7

(4, 13)

−5

(−12, 2)

0.22

−1

(−8, 5)

0.82

4

(−3, 11)

0.32

 7

12

(7, 19)

9

(5, 15)

7

(4, 13)

−5

(−12, 2)

0.22

−2

(−8, 5)

0.66

3

(−4, 11)

0.44

  1. 95%CI: 95% Confidence Interval
  2. *Dx worst is worst ear diagnosis according to a severity hierarchy of normal, OME, AOMwoP, AOMwiP, and CSOM
  3. **At one and two months tympanometry was used to distinguish normal from not normal. We assumed not normal was OM, but these children may have had any form of OM
  4. #Any Supp is suppurative OM which includes AOMwoP, AOMwiP, and CSOM
  5. ##Any TMP is tympanic membrane perforation which includes dry perforation, AOMwiP, and CSOM
  6. S is PHiD-CV10 (Synflorix™). P is PCV13 (Prevenar13™)
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