Table 1.
Demographic characteristics of the participants in the intention-to-treat population
| BBV152 3 μg with Algel-IMDG(n=100) | BBV152 6 μg with Algel-IMDG (n=100) | BBV152 6 μg with Algel(n=100) | Algel only (n=75) | ||
|---|---|---|---|---|---|
| Age, years | |||||
| Median (IQR) | 32·5 (25·0–40·0) | 35·0 (25·0–40·0) | 32·0 (25·0–40·0) | 29·0 (24·0–38·0) | |
| ≥18 to ≤25 | 29 (29%) | 28 (28%) | 31 (31%) | 22 (29%) | |
| ≥26 to ≤40 | 47 (47%) | 47 (47%) | 45 (45%) | 37 (49%) | |
| >40 to ≤55 | 24 (24%) | 25 (25%) | 24 (24%) | 16 (21%) | |
| Sex | |||||
| Men | 78 (78%) | 82 (82%) | 76 (76%) | 61 (81%) | |
| Women | 22 (22%) | 18 (18%) | 24 (24%) | 14 (19%) | |
| Body-mass index*, kg/m2 | 24·8 (3·5) | 25·8 (4·2) | 24·9 (3·7) | 24·6 (3·5) | |
| Vital signs | |||||
| Systolic blood pressure, mm Hg | 122·9 (8·5) | 123·5 (7·9) | 121·6 (8·3) | 123·6 (8·5) | |
| Diastolic blood pressure, mm Hg | 79·4 (5·9) | 79·3 (6·5) | 79·2 (5·3) | 79·4 (6·4) | |
| Pulse rate, beats per min | 77·4 (7·3) | 78·1 (8·2) | 78·0 (5·9) | 78·3 (7·6) | |
| Respiratory rate, breaths per min | 16·9 (2·3) | 16·7 (2·6) | 17·1 (2·6) | 16·9 (2·2) | |
| Temperature, °C | 36·6 (0·4) | 36·5 (0·6) | 36·5 (0·4) | 36·6 (0·4) | |
| Sites | |||||
| All India Institute of Medical Sciences, New Delhi | 3 (3%) | 6 (6%) | 3 (3%) | 4 (5%) | |
| All India Institute of Medical Sciences, Patna | 25 (25%) | 9 (9%) | 6 (6%) | 7 (9%) | |
| Gillukar Multispeciality Hospital | 10 (10%) | 14 (14%) | 19 (19%) | 12 (16%) | |
| Institute of Medical Sciences and SUM Hospital | 4 (4%) | 5 (5%) | 9 (9%) | 5 (7%) | |
| Jeevan Rekha Hospital | 1 (1%) | 1 (1%) | 2 (2%) | 0 | |
| Nizam's Institute of Medical Sciences | 11 (11%) | 14 (14%) | 15 (15%) | 7 (9%) | |
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences | 22 (22%) | 10 (10%) | 15 (15%) | 16 (21%) | |
| Prakhar Hospital | 8 (8%) | 10 (10%) | 11 (11%) | 10 (13%) | |
| Rana Hospital and Trauma Centre | 1 (1%) | 3 (3%) | 2 (2%) | 2 (3%) | |
| Redkar Hospital | 7 (7%) | 14 (14%) | 13 (13%) | 9 (12%) | |
| SRM Hospital and Research Center | 8 (8%) | 14 (14%) | 5 (5%) | 3 (4%) | |
Data are n (%) or mean (SD) unless otherwise stated. The intention-to-treat population included all participants who received at least one dose.
*
Calculation was based on the bodyweight and height measured at the time of screening. No data on race were collected; all participants were south Asian.