Table 2.
Primary and key secondary immunogenicity resultsa
| Time point and dosing regimen (group no.) | N | n | GMFR (95% CI) | P value |
|---|---|---|---|---|
| 28 days after 2nd vaccination (primary endpoint, day 56) | ||||
| 90 μg (+AAHSA)/90 μg (+AAHSA) (group 5) | 36 | 31 | 17.8 (13.0, 24.3) | <0.001 |
| 60 μg (+AAHSA)/60 μg (+AAHSA) (group 3) | 37 | 33 | 15.1 (11.0, 20.8) | <0.001 |
| 60 μg/60 μg (group 1) | 36 | 32 | 18.9 (13.7, 26.1) | <0.001 |
| PBO/PBO (group 6) | 18 | 16 | 1.1 (0.9, 1.4) | N/A |
| 28 days after 1st vaccination (day 28) | ||||
| 90 μg (+AAHSA) (group 5) | 36 | 35 | 12.9 (8.8, 18.8) | <0.001 |
| 60 μg (+AAHSA) (groups 3 and 4) | 74 | 68 | 12.9 (9.8, 16.9) | <0.001 |
| 60 μg (groups 1 and 2) | 73 | 68 | 11.9 (9.0, 15.6) | <0.001 |
| PBO/PBO (group 6) | 18 | 16 | 1.2 (0.9, 1.5) | N/A |
| 56 days after a single vaccination (day 56) | ||||
| 60 μg (+AAHSA)/PBO (group 4) | 37 | 34 | 11.8 (8.6, 16.1) | <0.001 |
| 60 μg/PBO (group 2) | 37 | 32 | 9.6 (7.1, 13.1) | <0.001 |
| PBO/PBO (group 6) | 18 | 16 | 1.1 (0.9, 1.4) | N/A |
| 180 days after first vaccination of a 2-dose regimen (day 180) | ||||
| 90 μg (+AAHSA)/90 μg (+AAHSA) (group 5) | 36 | 28 | 7.6 (5.5, 10.6) | <0.001 |
| 60 μg (+AAHSA)/60 μg (+AAHSA) (group 3) | 37 | 32 | 5.7 (4.2, 7.9) | <0.001 |
| 60 μg/60 μg (group 1) | 36 | 30 | 8.5 (6.2, 11.8) | <0.001 |
| PBO/PBO (group 6) | 18 | 14 | 1.0 (0.8, 1.3) | N/A |
a
PBO values are observed values; no formal statistical analysis was planned or performed. Values for the V710 treatment groups were based on a repeated-measures model adjusting for age at vaccination and baseline antibody level. N, number vaccinated at baseline; n, number contributing to analysis; GMFR, geometric mean fold rise from baseline; CI, confidence interval; AAHSA, amorphous aluminum hydroxyphosphate sulfate adjuvant; PBO, placebo; N/A, not applicable.