Table 1.
Summary of Demographic Characteristics (Exposed Set)
| Group | PCV-Free Lot A HRV n = 400 | PCV-Free Lot B HRV n = 396 | PCV-Free Lot C HRV n = 402 | Pooled PCV -Free HRV n = 1198 | HRV n = 402 | Total n = 1600 |
|---|---|---|---|---|---|---|
| Age at first vaccine dose | ||||||
| Mean ± SD, wk | 8.5 ± 1.5 | 8.4 ± 1.5 | 8.4 ± 1.6 | 8.4 ± 1.5 | 8.5 ± 1.5 | 8.4 ± 1.5 |
| Median (min-max), wk | 9.0 (6–12) | 8.0 (6–12) | 9.0 (6–12) | 9.0 (6–12) | 8.5 (6–13) | 9.0 (6–13) |
| Age at second vaccine dose | ||||||
| Mean ± SD, wk | 15.1 ± 2.6 | 15.1 ± 2.6 | 15.0 ± 2.6 | 15.1 ± 2.6 | 15.0 ± 2.6 | 15.1 ± 2.6 |
| Median (min-max), wk | 15.0 (10–22) | 15.0 (10–22) | 15.0 (10–22) | 15.0 (10–22) | 15.0 (10–21) | 15.0 (10–22) |
| Sex, n (%) | ||||||
| Male | 192 (48.0) | 198 (50.0) | 197 (49.0) | 587 (49.0) | 199 (49.5) | 786 (49.1) |
| Geographic ancestry, n (%) | ||||||
| American Indian or Alaska Native | 6 (1.5) | 2 (0.5) | 3 (0.7) | 11 (0.9) | 5 (1.2) | 16 (1.0) |
| Asian | 95 (23.8) | 96 (24.2) | 98 (24.4) | 289 (24.1) | 95 (23.6) | 384 (24.0) |
| African or African American | 6 (1.5) | 9 (2.3) | 13 (3.2) | 28 (2.3) | 13 (3.2) | 41 (2.6) |
| Native Hawaiian or other Pacific Islander | 1 (0.3) | 0 (0) | 0 (0) | 1 (0.1) | 0 (0) | 1 (0.1) |
| Caucasian, Arabic, or North African | 263 (65.8) | 258 (65.2) | 262 (65.2) | 783 (65.4) | 262 (65.2) | 1045(65.3) |
| Other | 29 (7.3) | 31 (7.8) | 26 (6.5) | 86 (7.2) | 27 (6.7) | 113 (7.1) |
| Country, n (%) | ||||||
| Costa Rica | 23 (5.8) | 22 (5.6) | 22 (5.5) | 67 (5.6) | 23 (5.7) | 90 (5.6) |
| Finland | 29 (7.3) | 29 (7.3) | 29 (7.2) | 87 (7.3) | 30 (7.5) | 117 (7.3) |
| Germany | 18 (4.5) | 17 (4.3) | 18 (4.5) | 53 (4.4) | 18 (4.5) | 71 (4.4) |
| Japan | 40 (10.0) | 40 (10.1) | 40 (10.0) | 120 (10.0) | 40 (10.0) | 160 (10.0) |
| Republic of Korea | 15 (3.8) | 15 (3.8) | 15 (3.7) | 45 (3.8) | 15 (3.7) | 60 (3.8) |
| Spain | 125 (31.3) | 125 (31.6) | 126 (31.3) | 376 (31.4) | 125 (31.1) | 501 (31.3) |
| Taiwan | 37 (9.3) | 37 (9.3) | 38 (9.5) | 112 (9.3) | 38 (9.5) | 150 (9.4) |
| United States | 113 (28.3) | 111 (28.0) | 114 (28.4) | 338 (28.2) | 113 (28.1) | 451 (28.2) |
| Mean height ± SD at first vaccine dose, cm | 57.6 ± 2.6 | 57.6 ± 2.5 | 57.8 ± 2.6 | 57.7 ± 2.6 | 57.6 ± 2.7 | 57.6 ± 2.6 |
| Mean weight ± SD at first vaccine dose, kg | 5.2 ± 0.7 | 5.3 ± 0.7 | 5.3 ± 0.7 | 5.3 ± 0.7 | 5.2 ± 0.7 | 5.3 ± 0.7 |
| Mean BMI ± SD at first vaccine dose, kg/m2 | 15.8 ± 1.6 | 15.9 ± 1.6 | 15.8 ± 1.6 | 15.8 ± 1.6 | 15.8 ± 1.6 | 15.8 ± 1.6 |
Abbreviations: BMI, body mass index; HRV, human rotavirus vaccine licensed at the time of study conduct; min-max, minimum-maximum; n (%), number (percentage) of infants in a given category; PCV-free Lot A/B/C HRV, lots A, B, C of the porcine circovirus-free human rotavirus vaccine; Pooled PCV-free HRV, pooled PCV-free lot A/B/C HRV groups.