Table 2.
Baseline Characteristics of Enrolled Subjects
| VACCINE GROUPS | |||||||
|---|---|---|---|---|---|---|---|
| 7.5 μg (N= 49) | 7.5 μg +Al(OH)3 (N= 51) | 15 μg (N= 51) | 15 μg + Al(OH)3 (N= 50) | 45 μg (N= 54) | Placebo (N= 51) | p-value | |
| Gender – N (%) | 0.079 | ||||||
| Male | 19 (39) | 27 (53) | 25 (49) | 23 (46) | 24 (44) | 22 (43) | |
| Female | 30 (61) | 24 (47) | 26 (51) | 27 (54) | 30 (56) | 29 (57) | |
| Ethnicity – N (%) | 0.45 | ||||||
| Non-Hispanic | 38 (78) | 42 (82) | 41 (80) | 46 (92) | 46 (85) | 44 (86) | |
| Hispanic | 11 (22) | 9 (18) | 10 (20) | 4 (8) | 8 (15) | 7 (14) | |
| Race – N (%) | 0.23 | ||||||
| Asian | 5 (10) | 8 (16) | 4 (8) | 3 (6) | 8 (15) | 8 (16) | |
| Hawaiian/Pacific Islander | 0 | 0 | 1 (2) | 1 (2) | 2 (4) | 0 | |
| Black/African American | 3 (6) | 3 (6) | 5 (10) | 5 (10) | 6 (11) | 6 (12) | |
| White | 31 (63) | 36 (71) | 39 (76) | 37 (74) | 31 (57) | 35 (69) | |
| Multi-Racial | 3 (6) | 1 (2) | 1 (2) | 3 (6) | 5 (9) | 0 | |
| Other/Unknown | 7 (14) | 3 (6) | 1 (2) | 1 (2) | 2 (4) | 2 (4) | |
| Age | 0.28 | ||||||
| Mean (STD) | 26.5 (4.6) | 28.7 (5.9) | 27.5 (5.4) | 27.4 (6.3) | 28.2 (5.8) | 26.6 (5.6) | |
| Antibody Level* | |||||||
| HAI GMT (CI) | 5.0 (5.0,5.1) | 5.0 (-) | 5.3 (4.7,5.9) | 5.5 (4.8,6.2) | 5.0 (-) | 5.1 (4.9,5.9) | 0.42 |
| Neut GMT (CI) | 5.0 (-) | 5.1 (4.9,5.2) | 5.4 (4.8,6.1) | 5/5 (4.9,6.1) | 5.2 (4.9,5.6) | 5.4 (4.9, 5.9) | 0.57 |
*
As determined in the SR Laboratory
Abbreviations: AlOH3=aluminum hydroxide; HAI=hemagglutination inhibition; Neut=neutralizing; GMT=geometric mean titer