Table 2.
Studies examining efficacy or effectiveness of 19F-containing vaccines against 19A carriage
| Study & location | Vaccine | Vaccine regimen | Age group(s) sampled | Number of Subjects | Number of 19F isolates | Efficacy against 19F VE or OR (95% CI or p value) |
Number of 19A isolates | Efficacy against 19A VE or OR (95% CI or p value) |
|---|---|---|---|---|---|---|---|---|
| South Africa [42]: double blind, randomized, efficacy | 9vCRM | 6,10,14 wk | 9 mo | 242 (vacc) 239 (ctrl) |
19 (vacc) 32 (ctrl) |
VE 42%* (p = 0.05) | 7 (vacc) 11 (ctrl) |
VE 37%* (NS) |
| Israel [43]: double blind, randomized efficacy | 9vCRM | 12-24 mo received 2 doses; ≥ 24 mo 1 dose | 15-35 mo 36-≥ 48 mo | 816 (vacc) 790 (ctrl) 1071 (vacc) 1073 (ctrl) |
41 (vacc) 62 (ctrl) 57 (vacc) 52 (ctrl) |
OR 0.58 (p = 0.08) OR 1.11 (p = 0.69) |
n.a. = 113 total (all groups combined) | OR 0.60** (p = 0.38) OR 1.25** (p = 0.56) |
| US Navajo Apache [21]: double blind, randomized efficacy | 7vCRM | 2,4,6,12-15 mo (87%) | 1-7 y (median 3.3y) All >12 mo since last dose |
468 (vacc) 281 (ctrl) |
24 (vacc) 16 (ctrl) |
OR 0.89 (0.47-1.72) | 12 (vacc) 10 (ctrl) |
OR 0.71 (0.30-1.67) |
| US Navajo Apache [23]: double blind, randomized efficacy | 7vCRM | 2,4,6,12-15 mo | 7 mo | 227 (vacc) 226 (ctrl) |
2 (vacc) 11 (ctrl) |
OR not calculated because "small sample size resulted in non-convergence of model" | 10 (vacc) 4 (ctrl) |
OR 1.75 (0.41-7.58) |
| 12 mo | 226 (vacc) 208 (ctrl) |
7 (vacc) 8 (ctrl) |
3 (vacc) 7 (ctrl) |
OR 0.38 (0.09-1.57) | ||||
| 18 mo | 239 (vacc) 219 (ctrl) |
18 (vacc) 8 (ctrl) |
14 (vacc) 10 (ctrl) |
OR 1.68 (0.7-4.05) | ||||
| US Navajo Apache [22]: double blind, randomized efficacy | 7vCRM | Infants: 2,4,6, 12-15 mo; 12-23 mo: 2 doses | Unvaccinated children/adults in study households | 2048 (vacc) 1376 (ctrl) |
29 (vacc) 37 (ctrl) |
OR 0.52 (0.31-0.87) | 15 (vacc) 23 (ctrl) |
OR 0.34 (0.16-0.75) |
| France [44]: effectiveness | 7vCRM | ≥ 1 dose | Children w/AOM 6-24 mo (mean 14 mo) | 575 (vacc) 1331 (ctrl) |
59 (vacc) 178 (ctrl) |
24%* (p = 0.06) | 50 (vacc) 92 (ctrl) |
-26%* (p = 0.2) |
| Greece [45]: effectiveness | 7vCRM | 12-23 mo: 2 doses (13%); ≥ 24 mo: 1 dose (85%) | 13-76 mo (median 47 mo) | 285 (vacc) 582 (ctrl) |
24 (vacc) 64 (ctrl) |
36%* | 3 (vacc) 14 (ctrl) |
58%* |
*Only case numbers provided in original paper; approximate % VE calculated for this table;
**confidence intervals for odds rations not provided in original publication.
Mo, month; NS; not significant; OR, odds ratio; VE, vaccine efficacy/effectiveness; wk, week; y, year. 7vCRM, 7-valent conjugate vaccine with CRM197 carrier. 9vCRM; 9-valent conjugate vaccine candidate with CRM197 carrier.