Table 1

Studies examining efficacy or effectiveness of 19F-containing vaccines against 19A IPD and AOM

Study or Analysis

Vaccine

Vaccine regimen

Endpoint

Age group

Total Number of Subjects

Numbers of 19F Cases

% VE against 19F

(95% CI)

Numbers of 19A Cases

% VE against 19A

(95% CI)


Polysaccharide vaccine

IPD


US indirect cohort analysis [37]

PS14-V*

1 dose as per US recomm.

IPD

> 5 y

2837 total cases

12 (vacc)

32(unvacc)

11

(-86,,56)

10 (vacc)

42(unvacc)

44

(-21, 74)



Conjugate vaccines

IPD


N. California Kaiser Permanente efficacy [15,38]a

7vCRM

2,4,6,12-15 mo

IPD after ≥ 3 doses

2 mo to ~3.5 y

18927 (vacc)

18941 (ctrl)

2 (vacc)

13 (ctrl)

85

(32, 97)

0 (vacc)

1 (ctrl)

67

(-719, 99)


Native Americans efficacy

[16,38]a

7vCRM

2,4,6,12-15 mo

IPD after ≥ 3 doses

2 mo to 2 y

7532 (vacc)

7151 (ctrl)

0 (vacc)

1 (ctrl)

68

(-677, 99)

1 (vacc)

0(ctrl)

-185

(-900, 88)


South African HIV- efficacy [17,38]a

9vCRM

6, 10, 14 wks

IPD after 3 doses

6 wk to 6.2 y

18633 (vacc)

18626 (ctrl)

0 (vacc)

1 (ctrl)

67

(-718, 99)

3 (vacc) 1 (ctrl)

-200

(-900, 69)


South African HIV+ efficacy [17,38]a

9vCRM

6, 10, 14 wks

IPD after 3 doses

6 wk to 6.2 y

1289 (vacc)

1288 (ctrl)

5 (vacc)

3 (ctrl)

-67

(-595,60)

3 (vacc)

6 (ctrl)

50

(-99, 88)


Gambia efficacy

[14,39]a

9vCRM

6, 10, 14 wks

IPD after 3 doses

6 wk to 2.9 y

8718 (vacc)

8719 (ctrl)

0 (vacc)

2 (ctrl)

80

(-317, 99)

6 (vacc)

7 (ctrl)

14

(-155, 71)


Meta-analysis of preceding efficacy studies(a)

7vCRM & 9vCRM

see individual studies

55099 (vacc)

54725 (ctrl)

7 (vacc)

20 (ctrl)

61

(13, 82)

13 (vacc)

15 (ctrl)

13

(-79, 58)


US post-marketing surveillance [19]

7vCRM

2,4,6,12-15 mo; catch-up schedule for < 2 y

IPD (2nd yr after launch)

> 2 y (not all vacc)

~433,000

79 (pre)

14 (post)

83

(72, 90)

(% decrease decrease in estimated rate from pre-7vCRM)

20 (pre)

12 (post)

40

(-5, 68)

(% decrease in estimated rate from pre-7vCRM)


US CDC case-control [9]

7vCRM

2,4,6,12-15 mo

IPD ≥ 1 dose

3 to 59 mo

n.a.

34 discordant sets

87

(65, 95)

46 discordant sets

26

(-45, 62)


Canada (Québec) [40]: case-control

7vCRM

2,4,12 mo

IPD ≥ 1 dose

<5 y

n.a.

3 (vacc); 8 (unvacc)

93 (61,99)

29 (vacc); 8 (unvacc)

42

(-76, 79)



Conjugate Vaccines

AOM


Finland [10]: efficacy (FinOM)

7vCRM

2,4,6,12 mo

AOM after ≥ 3 doses

6.5 to 24 mo

831 (vacc)

831 (ctrl)

43 (vacc)

58 (ctrl)

25

(-14, 51)

17 (vacc)

26 (ctrl)

34

(-26, 65)


Finland [41]: efficacy(FinOM)

7vOMP

2,4,6,12 mo

AOM after ≥ 3 doses

6.5 to 24 mo

831 (vacc)

831 (ctrl)

37 (vacc)

58 (ctrl)

37

(1, 59)

22 (vacc)

26 (ctrl)

16

(-53, 54)


Czech/Slovak [11]: efficacy (POET)

11Pn-PD

3,4,5,12-15 mo

AOM after ≥ 3 doses

5 to 27 mo

2489 (vacc)

2479 (ctrl)

24 (vacc)

43 (ctrl)

44

(8, 66)

1 (vacc)

3 (ctrl)

67

(-209, 97)


*PS14-V, 14 valent polysaccharide vaccine, contained 19F but not 19A; it was replaced in the early 1980s by the 23-valent vaccine containing both 19A and 19F serotypes. aEach of the 5 analyses (from 4 separate studies) is also included in the metanalysis in italics. Mo, month; n.a., not available; VE, vaccine efficacy/effectiveness; wk, week; y, year; vacc, active vaccine group; unvacc, unvaccinated; ctrl, control; 7vCRM, 7-valent conjugate vaccine with CRM197 carrier; 9vCRM, 9-valent conjugate vaccine candidate with CRM197 carrier; 7vOMP, 7-valent conjugate vaccine candidate with outer membrane protein carrier; IPD, invasive pneumococcal disease; AOM, acute otitis media

Hausdorff et al. BMC Pediatrics 2010 10:4   doi:10.1186/1471-2431-10-4

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