Table 1.
Baseline maternal characteristics at the time of vaccination
| Cohort 1 | Cohort 2 | Combined | ||||
|---|---|---|---|---|---|---|
|
|
|
|
||||
| Placebo (N=1041) |
Vaccine (N=1049) |
Placebo (N=805) |
Vaccine (N=798) |
Placebo (N=1846) |
Vaccine (N=1847) |
|
| Age (years) | 23·0 (4·6) | 23·2 (4·5) | 23·2 (4·7) | 23·4 (5·0) | 23·1 (4·7) | 23·3 (4·7) |
|
| ||||||
| Gestational age | ||||||
| 17–25 weeks | 768 (74%) | 774 (74%) | 385 (48%) | 379 (48%) | 1153 (63%) | 1153 (62%) |
| 26–34 weeks | 273 (26%) | 275 (26%) | 420 (52%) | 419 (53%) | 693 (38%) | 694 (38%) |
|
| ||||||
| Gestational age (weeks) | 22·2 (5·2) | 22·0 (5·3) | 25·2 (4·2) | 25·3 (4·3) | 23·5 (5·1) | 23·4 (5·2) |
|
| ||||||
| Systolic/diastolic blood pressure (mm Hg) | 99·9 (9·8)/66·3 (8·6) | 100·4 (9·8)/66·7 (9·4) | 100·7 (9·8)/67·1 (8·8) | 100·7 (9·4)/66·9 (8·6) | 100·3 (9·8)/66·6 (8·7) | 100·5 (9·6)/66·7 (9·1) |
|
| ||||||
| Height (cm) | 151·5 (5·6) | 151·7 (5·6) | 151·7 (5·5) | 151·6 (5·3) | 151·6 (5·6) | 151·6 (5·5) |
|
| ||||||
| Weight (kg) | 48·0 (7·2) | 48·8 (7·9) | 48·3 (7·1) | 48·4 (7·5) | 48·1 (7·1) | 48·6 (7·8) |
|
| ||||||
| BMI (kg/m2) | 20·9 (2·8) | 21·2 (3·0) | 20·9 (2·7) | 21·1 (2·9) | 20·9 (2·7) | 21·1 (3·0) |
| <16 | 14 (1%) | 14 (1%) | 9 (1%) | 8 (1%) | 23 (1%) | 22 (1%) |
| 16–18·5 | 177 (17%) | 159 (15%) | 139 (17%) | 128 (16%) | 316 (17%) | 287 (16%) |
| 18·5–25 | 765 (74%) | 773 (74%) | 597 (74%) | 589 (74%) | 1362 (74%) | 1362 (74%) |
| >25 | 81 (8%) | 98 (9%) | 60 (8%) | 71 (9%) | 141 (8%) | 169 (9%) |
|
| ||||||
| No education | 427 (43%) | 446 (44%) | 300 (39·8%) | 298 (40·5%) | 727 (42%) | 744 (43%) |
|
| ||||||
| Nulliparous | 417 (40%) | 413 (39%) | 372 (46%) | 346 (43%) | 789 (43%) | 759 (41%) |
|
| ||||||
| Gravidity | 1·3 (1·5) | 1·3 (1·5) | 1·1 (1·4) | 1·1 (1·3) | 1·2 (1·5) | 1·2 (1·4) |
|
| ||||||
| Parity | 1·2 (1·6) | 1·2 (1·5) | 1·0 (1·4) | 1·0 (1·6) | 1·1 (1·5) | 1·1 (1·5) |
|
| ||||||
| History of child deaths* | 103 (18%) | 86 (15%) | 51 (12%) | 44 (10%) | 154 (15%) | 130 (13%) |
|
| ||||||
| History of stillbirths* | 45 (7%) | 35 (6%) | 14 (3%) | 20 (4%) | 59 (6%) | 55 (5%) |
Data are mean (SD) or n (%). BMI=body-mass index.
*
Among women with at least one previous live birth; includes 11 pregnancies in cohort 2, six in the placebo group and five in the vaccine group (vaccine group: three infants, one twin pair), who were vaccinated within 14 days of delivery. Includes nine pregnancies in cohort 1, four in placebo and five in vaccine group, who were vaccinated within 14 days of delivery.