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