Table 1.
Demographic characteristics (total vaccinated cohorts and ATP cohorts for immunogenicity).
| Primary phase |
Booster phase |
|||||
|---|---|---|---|---|---|---|
| Groups | Group 1 (DTaP-HBV-IPV/Hib) | Group 2 (DTaP-HBV-IPV + HibA) | Group 3 (DTaP-IPV/Hib + HBV) |
Group 1 (DTaP + HibB) | Group 2 (DTaP + HibA) | Group 3 (DTaP-IPV/Hib) |
| Total vaccinated cohort | N = 195 | N = 194 | N = 196 | N = 167 | N = 158 | N = 161 |
| Mean age at dose 1 (weeks)/booster dose (months) ± SD | 8.5 ± 1.0 | 8.6 ± 1.1 | 8.6 ± 1.1 | 15.3 ± 0.7 | 15.3 ± 0.6 | 15.3 ± 0.7 |
| Girls, n (%) | 101 (51.8) | 80 (41.2) | 95 (48.5) | 87 (52.1) | 58 (36.7) | 73 (45.3) |
| Race, n (%) | ||||||
| White Caucasian/European heritage | 118 (60.5) | 128 (66.0) | 115 (58.7) | 101 (60.5) | 101 (63.9) | 94 (58.4) |
| African/African American | 16 (8.2) | 9 (4.6) | 20 (10.2) | 14 (8.4) | 9 (5.7) | 16 (9.9) |
| American Indian or Alaskan Native | 15 (7.7) | 15 (7.7) | 17 (8.7) | 12 (7.2) | 14 (8.9) | 16 (9.9) |
| Other | 46 (23.6) | 42 (21.7) | 44 (22.4) | 40 (23.9) | 34 (21.5) | 35 (21.8) |
| Hepatitis B vaccination at birth, n (%) | 181 (92.8) | 172 (88.7) | 180 (91.8) | 153 (91.6) | 139 (88.0) | 149 (92.5) |
| Tdap vaccination of mother, n (%) | ||||||
| Yes | 102 (66.7) | 94 (62.7) | 98 (60.9) | 90 (67.7) | 85 (68.0) | 82 (59.9) |
| No | 51 (33.3) | 56 (37.3) | 63 (39.1) | 43 (32.3) | 40 (32.0) | 55 (40.1) |
| Missing | 42 | 44 | 35 | 34 | 33 | 24 |
| ATP cohort | N = 154 | N = 156 | N = 156 | N = 138 | N = 139 | N = 131 |
| Mean age at dose 1 (weeks)/booster dose (months) ± (SD) | 8.6 ± 0.9 | 8.6 ± 1.1 | 8.6 ± 1.0 | 15.3 ± 0.6 | 15.3 ± 0.6 | 15.3 ± 0.7 |
| Girls, n (%) | 85 (55.2) | 61 (39.1) | 74 (47.4) | 72 (52.2) | 47 (33.8) | 58 (44.3) |
| Race, n (%) | ||||||
| White Caucasian/European heritage | 98 (63.6) | 106 (67.9) | 89 (57.1) | 84 (60.9) | 90 (64.7) | 72 (55.0) |
| African/African American | 13 (8.4) | 8 (5.1) | 17 (10.9) | 12 (8.7) | 8 (5.8) | 12 (9.2) |
| American Indian or Alaskan Native | 12 (7.8) | 8 (5.1) | 16 (10.3) | 11 (8.0) | 10 (7.2) | 14 (10.7) |
| Other | 31 (20.2) | 34 (21.9) | 34 (21.7) | 31 (22.4) | 31 (22.3) | 33 (25.1) |
| Hepatitis B vaccination at birth, n (%) | 143 (92.9) | 136 (87.2) | 144 (92.3) | 129 (93.5) | 122 (87.8) | 120 (91.6) |
| Tdap vaccination of mother, n (%) | ||||||
| Yes | 83 (66.4) | 79 (64.8) | 81 (61.4) | 79 (69.9) | 75 (68.2) | 73 (62.9) |
| No | 42 (33.6) | 43 (35.2) | 51 (38.6) | 34 (30.1) | 35 (31.8) | 43 (37.1) |
| Missing | 29 | 34 | 24 | 25 | 29 | 15 |
ATP, according-to-protocol; DTaP-HBV-IPV/Hib, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b (Hib) vaccine; DTaP-HBV-IPV, diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine; DTaP-IPV/Hib, diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Hib vaccine; DTaP, diphtheria, tetanus, acellular pertussis vaccine; HibA, HibB, monovalent Hib conjugate vaccines; N, number of participants in each group; SD, standard deviation; n (%), number (percentage) of participants in each category; Tdap, reduced antigen content tetanus, diphtheria, acellular pertussis vaccine.