Table 1.
Demographics and baseline characteristics and of all participants who received at least one study injection
| Tetravalent (n=110) | Trivalent (n=55) | Placebo (n=33) | ||
|---|---|---|---|---|
| Sex | ||||
| Female | 54 (49%) | 32 (58%) | 24 (73%) | |
| Male | 56 (51%) | 23 (42%) | 9 (27%) | |
| Age, years | 30·1 (18–50) | 31·0 (19–50) | 28·2 (18–44) | |
| Country | ||||
| USA | 100 (91%) | 50 (91%) | 31 (94%) | |
| Rwanda | 10 (9%) | 5 (9%) | 2 (6%) | |
| Race | ||||
| White | 58 (53%) | 24 (44%) | 23 (70%) | |
| Black or African American | 35 (32%) | 18 (32%) | 7 (21%) | |
| Asian | 5 (5%) | 5 (9%) | 0 | |
| Other | 12 (11%) | 8 (15%) | 3 (9%) | |
| Ethnicity | ||||
| Hispanic or Latino | 13 (12%) | 6 (11%) | 4 (12%) | |
| Not Hispanic or Latino | 96 (87%) | 48 (87%) | 29 (88%) | |
| Not reported | 1 (1%) | 1 (2%) | 0 | |
| Height, cm | 170 (149–195) | 170 (147–197) | 169 (155–189) | |
| Weight, kg | 77 (50–150) | 80 (46–141) | 77 (53–132) | |
| Body-mass index | 26·3 (17·3–46·6) | 27·6 (17·3–41·6) | 26·9 (17·9–38·8) | |
| Completed study | ||||
| All visits to week 72 | 94 (86%) | 45 (82%) | 28 (85%) | |
| Received three vaccinations* | 100 (91%) | 50 (91%) | 32 (97%) | |
| Received four vaccinations | 93 (85%) | 44 (80%) | 27 (82%) | |
| Reasons for study discontinuation† | ||||
| Adverse event | 0 | 1 (2%) | 1 (3%) | |
| Lost to follow-up | 5 (5%) | 4 (7%) | 3 (9%) | |
| Pregnancy | 1 (1%) | 1 (2%) | 0 | |
| Protocol violation | 1 (1%) | 0 | 0 | |
| Withdrawal by participant | 6 (6%) | 4 (7%) | 1 (3%) | |
| Other | 3 (3%) | 0 | 0 | |
Data are n (%) or mean (min–max).
*
Includes those who missed the third vaccination but received the fourth on schedule.
†
Does not include the three participants who did not receive a vaccine.