Table 4. Concomitant Antigen Antibody Responses at 8 Months of Age After Completion of Primary Vaccination.
| Antibody | Threshold | aP Groupa | Control Groupb | P Value for GMC | P Value for Reaching Protective Thresholdd | ||
|---|---|---|---|---|---|---|---|
| No./Total No. (% >Threshold)c | GMC, ELU/mL (95% CI) | No./Total No. (% >Threshold)c | GMC, ELU/mL (95% CI) | ||||
| Hepatitis B | >10 mIU/mL | 149/150 (99.3) | 1218 (984-1506) | 145/145 (100) | 2275 (1883-2747) | <.001 | .33 |
| >100 mIU/mL | 143/150 (95.3) | 141/145 (97.2) | <.001 | .39 | |||
| Hib | >0.15 μg/mL | 176/182 (96.7) | 1.53 (1.27-1.85) | 177/183 (96.7) | 2.12 (1.76-2.57) | .02 | .99 |
| >1 μg/mL | 111/182 (61.0) | 136/183 (74.3) | .02 | .006 | |||
| Diphtheria | >0.1 IU/mL | 180/181 (99.4) | 1.24 (1.09-1.41) | 183/183 (100) | 1.78 (1.57-2.03) | <.001 | .31 |
| >1 IU/mL | 106/181 (58.6) | 140/183 (76.5) | <.001 | <.001 | |||
| Tetanus | >0.1 IU/mL | 181/181 (100) | 2.04 (1.84-2.27) | 183/183 (100) | 2.69 (2.44-2.96) | <.001 | |
| >1 IU/mL | 149/181 (82.3) | 170/183 (92.9) | <.001 | .002 | |||
| Pneumococcal serotype | |||||||
| PnC 1 | NC | 186 | 0.93 (0.82-1.06) | 179 | 0.93 (0.82-1.06) | .98 | NC |
| PnC 4 | NC | 186 | 1.54 (1.37-1.73) | 179 | 1.51 (1.36-1.68) | .86 | NC |
| PnC 5 | NC | 186 | 2.15 (1.91-2.42) | 179 | 1.89 (1.67-2.14) | .14 | NC |
| PnC 6A | NC | 186 | 0.33 (0.27-0.39) | 179 | 0.29 (0.24-0.35) | .36 | NC |
| PnC 6B | NC | 186 | 0.85 (0.75-0.98) | 179 | 0.73 (0.64-0.83) | .10 | NC |
| PnC 7F | NC | 186 | 2.05 (1.83-2.29) | 179 | 1.97 (1.77-2.20) | .62 | NC |
| PnC 9V | NC | 186 | 1.74 (1.53-1.99) | 179 | 1.52 (1.34-1.73) | .15 | NC |
| PnC 14 | NC | 186 | 2.46 (2.13-2.84) | 179 | 2.57 (2.23-2.97) | .66 | NC |
| PnC 18C | NC | 186 | 2.63 (2.25-3.08) | 179 | 2.25 (1.93-2.64) | .17 | NC |
| PnC 19A | NC | 186 | 0.27 (0.23-0.32) | 179 | 0.27 (0.23-0.31) | .92 | NC |
| PnC 19F | NC | 186 | 3.25 (2.84-3.73) | 179 | 3.14 (2.76-3.57) | .72 | NC |
| PnC 23F | NC | 186 | 1.02 (0.88-1.18) | 179 | 0.93 (0.81-1.07) | .36 | NC |
Abbreviations: aP, acellular pertussis; ELU, enzyme-linked immunosorbent assay units; GMC, geometric mean concentration; Hib, Haemophilus influenzae type b; NC, not calculated; PnC, pneumococcal serotype.
a
The aP group received the aP vaccine and the hepatitis B vaccine at birth, then diphtheria, tetanus, aP, hepatitis B, and Hib antigens at 6 weeks, 4 months, and 6 months of age.
b
The control group received the hepatitis B vaccine at birth, then diphtheria, tetanus, aP, hepatitis B, and Hib antigens at 6 weeks, 4 months, and 6 months of age.
c
Protocol participants who had blood samples collected for antibody analysis.
d
Determined by use of the χ2 test.