TABLE 1.
Proportion of subjects with hSBA titers of ≥8 in the intention-to-treat population
| Primary vaccine | Secondary vaccine | No. of subjects with titers of ≥8/total no. of subjects; % (95% CI) |
|||
|---|---|---|---|---|---|
| 28 days after primary | 10 mo after primary | 28 days after 2nd vaccined | 14 mo after 2nd vaccined | ||
| PsA-TT | 42/57; 73.7a (60.3, 84.5) | 11/55; 20.0b (10.4, 33.0) | |||
| PsA-TT | 11/13; 84.6 (54.6, 98.1) | 12/15; 80.0 (51.9, 95.7) | |||
| PsACWY | 22/22; 100.0 (84.6, 100.0) | 16/22; 72.7 (49.8, 89.3) | |||
| Hib | 3/18; 16.7 (3.6, 41.4) | 4/19; 21.1 (6.1, 45.6) | |||
| PsACWY | 20/61; 32.8c (21.3, 46.0) | 1/61; 1.6 (0.0, 8.8) | |||
| PsA-TT | 13/19; 68.4 (43.4, 87.4) | 7/20; 35.0 (15.4, 59.2) | |||
| PsACWY | 9/17; 52.9 (27.8, 77.0) | 5/18; 27.8 (9.7, 53.5) | |||
| Hib | 2/21; 9.5 (1.2, 30.4) | 8/22; 36.4 (17.2, 59.3) | |||
| Hib | 8/62; 13.1 (5.8, 24.2) | 3/59; 5.1 (1.1, 14.1) | |||
| PsA-TT | 6/16; 37.5 (15.2, 64.6) | 5/16; 31.3 (11.0, 58.7) | |||
| PsACWY | 4/22; 18.2 (5.2, 40.3) | 3/20; 15.0 (3.2, 37.9) | |||
| Hib | 1/18; 5.6 (0.1, 27.3) | 4/19; 26.3 (9.1, 51.2) | |||
Fisher's exact test of percentage of subjects with titers of ≥8, P < 0.0001 for PsA-TT compared to PsACWY and compared to Hib at 28 days after primary immunization.
Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0014 for PsA-TT compared to PsACWY, and P = 0.0212 for PsA-TT compared to Hib at 10 months after primary immunization.
Fisher's exact test of percentage of subjects with titers of ≥8, P = 0.0169 for PsACWY compared to Hib at 28 days after primary immunization.
No significance testing performed.