Table 3.
Functional antibody responses to PCV10 in the per-protocol population 4 weeks after booster vaccination (or at age 10 months for group B)
|
Proportion of participants with an opsonisation index of ≥8 |
Risk difference between group A and group C |
Geometric mean opsonisation index |
Ratio of geometric mean opsonisation indices between group A and group C | |||||
|---|---|---|---|---|---|---|---|---|
| Group A (3+1 schedule; n=71)* | Group C (2+1 schedule; n=121)* | Group B (3+0 schedule; n=75)† | Group A (3+1 schedule; n=71)* | Group B (2+1 schedule; n=121)* | Group C (3+0 schedule; n=75)† | |||
| Vaccine serotypes | ||||||||
| 1 | 97·2% (90·2 to 99·7) | 90·9% (84·3 to 95·4) | 42·7% (31·3 to 54·6) | 6·3% (−1·7 to 13·0) | 191 (135 to 270) | 145 (106 to 198) | 10 (8 to 14) | 1·32 (0·81 to 2·14) |
| 4 | 100% (94·9 to 100) | 99·2% (95·5 to 100) | 85·1% (75·0 to 92·3) | 0·8% (−4·4 to 4·5) | 1836 (1463 to 2304) | 1280 (1072 to 1529) | 152 (96 to 239) | 1·43 (1·08 to 1·91) |
| 5 | 100% (94·9 to 100) | 98·3% (94·2 to 99·8) | 95·9% (88·6 to 99·2) | 1·7% (−3·6 to 5·8) | 1145 (913 to 1436) | 768 (627 to 941) | 103 (75 to 142) | 1·49 (1·09 to 2·04) |
| 6B | 100% (94·9 to 100) | 96·7% (91·8 to 99·1) | 81·3% (70·7 to 89·4) | 3·3% (−2·2 to 8·2) | 425 (306 to 590) | 299 (224 to 399) | 73 (46 to 114) | 1·42 (0·91 to 2·23) |
| 7F | 100% (94·9 to 100) | 100% (97·0 to 100) | 93·3% (85·1 to 97·8) | 0·0% (−5·1 to 3·1) | 913 (639 to 1306) | 484 (369 to 636) | 165 (113 to 242) | 1·89 (1·21 to 2·95) |
| 9V | 100% (94·9 to 100) | 94·2% (88·4 to 97·6) | 88·0% (78·4 to 94·4) | 5·8% (−0·1 to 11·5) | 483 (332 to 702) | 308 (217 to 436) | 74 (50 to 110) | 1·57 (0·92 to 2·68) |
| 14 | 100% (94·9 to 100) | 96·7% (91·8 to 99·1) | 90·7% (81·7 to 96·2) | 3·3% (−2·2 to 8·2) | 754 (548 to 1038) | 394 (293 to 531) | 134 (88 to 205) | 1·91 (1·21 to 3·02) |
| 18C | 100% (94·9 to 100) | 99·2% (95·5 to 100) | 76·0% (64·7 to 85·1) | 0·8% (−4·4 to 4·5) | 1039 (779 to 1387) | 732 (564 to 950) | 35 (24 to 51) | 1·42 (0·95 to 2·12) |
| 19F | 100% (94·9 to 100) | 100% (97·0 to 100) | 94·6% (86·7 to 98·5) | 0·0% (−5·1 to 3·1) | 1807 (1431 to 2281) | 1579 (1380 to 1807) | 186 (135 to 256) | 1·14 (0·89 to 1·47) |
| 23F | 97·2% (90·2 to 99·7) | 91·7% (85·3 to 96·0) | 73·3% (61·9 to 82·9) | 5·4% (−2·4 to 12·1) | 262 (181 to 378) | 149 (109 to 202) | 35 (24 to 52) | 1·76 (1·08 to 2·86) |
| Cross-reacting serotypes | ||||||||
| 6A | 78·9% (67·6 to 87·7) | 66·9% (57·8 to 75·2) | 48·6% (36·9 to 60·6) | 11·9% (−1·4 to 23·7) | 211 (122 to 364) | 118 (74 to 189) | 38 (21 to 68) | 1·79 (0·85 to 3·74) |
| 19A | 69·0% (56·9 to 79·5) | 61·2% (51·9 to 69·9) | 18·7% (10·6 to 29·3) | 7·9% (−6·3 to 20·9) | 38 (24 to 59) | 25 (18 to 34) | 6 (5 to 7) | 1·52 (0·89 to 2·61) |
Data in parentheses are 95% CIs. Serotype-specific geometric mean opsonisation index and percentage of participants with an opsonisation index of ≥8 at 4 weeks after the booster vaccination for group A (3+1 schedule at ages 2, 3, 4, and 9 months); group C (2+1 schedule at ages 2, 4, and 9·5 months); and group B (3+0 schedule at ages 2, 3, and 4 months).
Opsonophagocytic assays were done in half of participants per group (75 from group A, 125 from group C, and 75 from group B); however, eight participants (four from group A and four from group C) had their post-booster blood sample collected outside of the study window (23–43 days after vaccination) and so were excluded from the analysis.
n=74 for serotypes 4, 5, 19F, and 6A because one sample in group B was not tested because insufficient serum sample was collected.