Table 1.
Immunogenicity of PCV10 after the primary vaccination series in the per-protocol population
|
Proportion of participants with IgG concentration ≥0·35 μg/mL |
Risk difference (primary outcome) |
GMC, μg/mL |
GMC ratio |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Groups A and B combined (n=286) | Group C (n=237) | Group D (n=185) | Groups A and B combined vs group C (90% CI) | Group D vs group C (95% CI) | Groups A and B combined (n=286) | Group C (n=237) | Group D (n=185) | Groups A and B combined vs group C | Group D vs group C | |
| Vaccine serotypes | ||||||||||
| 1 | 98·3% (96·0 to 99·4) | 97·9% (95·1 to 99·3) | 99·5% (97·0 to 100) | 0·4% (−1·7 to 2·7) | 1·6% (−1·2 to 4·3) | 2·79 (2·51 to 3·10) | 2·21 (1·97 to 2·48) | 3·40 (3·01 to 3·84) | 1·26 (1·08 to 1·47) | 1·54 (1·30 to 1·82) |
| 4 | 99·0% (97·0 to 99·8) | 98·7% (96·3 to 99·7) | 100% (98·0 to 100) | 0·2% (−1·5 to 2·2) | 1·3% (−0·9 to 3·7) | 3·85 (3·44 to 4·31) | 3·21 (2·87 to 3·58) | 4·28 (3·83 to 4·79) | 1·20 (1·03 to 1·41) | 1·34 (1·14 to 1·57) |
| 5 | 98·6% (96·5 to 99·6) | 95·8% (92·4 to 98·0) | 98·4% (95·3 to 99·7) | 2·8% (0·4 to 5·6) | 2·6% (−1·0 to 6·1) | 1·81 (1·67 to 1·97) | 1·17 (1·07 to 1·27) | 1·31 (1·19 to 1·43) | 1·55 (1·38 to 1·75) | 1·12 (0·99 to 1·26) |
| 6B | 84·6% (79·9 to 88·6) | 76·8% (70·9 to 82·0) | 96·2% (92·4 to 98·5) | 7·8% (2·1 to 13·6) | 19·4% (13·2 to 25·5) | 1·08 (0·95 to 1·23) | 0·80 (0·69 to 0·92) | 2·59 (2·25 to 2·99) | 1·36 (1·12 to 1·64) | 3·25 (2·66 to 3·97) |
| 7F | 99·3% (97·5 to 99·9) | 98·7% (96·3 to 99·7) | 100% (98·0 to 100) | 0·6% (−1·0 to 2·5) | 1·3% (−0·9 to 3·7) | 3·04 (2·79 to 3·32) | 2·07 (1·89 to 2·27) | 2·20 (2·01 to 2·40) | 1·47 (1·29 to 1·66) | 1·06 (0·93 to 1·21) |
| 9V | 99·3% (97·5 to 99·9) | 96·2% (92·9 to 98·2) | 98·9% (96·1 to 99·9) | 3·1% (1·0 to 5·8) | 2·7% (−0·6 to 6·1) | 2·47 (2·26 to 2·71) | 1·63 (1·47 to 1·81) | 2·40 (2·17 to 2·66) | 1·51 (1·32 to 1·74) | 1·47 (1·27 to 1·71) |
| 14 | 100% (98·7 to 100) | 98·3% (95·7 to 99·5) | 98·9% (96·1 to 99·9) | 1·7% (0·4 to 3·7) | 0·6% (−2·4 to 3·3) | 9·76 (8·79 to 10·83) | 5·86 (5·11 to 6·73) | 8·59 (7·43 to 9·94) | 1·66 (1·41 to 1·97) | 1·47 (1·20 to 1·79) |
| 18C | 98·6% (96·5 to 99·6) | 96·6% (93·5 to 98·5) | 98·4% (95·3 to 99·7) | 2·0% (−0·3 to 4·6) | 1·8% (−1·7 to 5·1) | 3·87 (3·47 to 4·30) | 1·86 (1·64 to 2·11) | 2·95 (2·61 to 3·34) | 2·08 (1·76 to 2·44) | 1·59 (1·33 to 1·89) |
| 19F | 99·7% (98·1 to 100) | 99·2% (97·0 to 99·9) | 100% (98·0 to 100) | 0·5% (−0·8 to 2·2) | 0·8% (−1·3 to 3·0) | 8·34 (7·52 to 9·24) | 9·54 (8·37 to 10·87) | 16·47 (14·50 to 18·72) | 0·87 (0·74 to 1·03) | 1·73 (1·43 to 2·08) |
| 23F | 90·6% (86·6 to 93·7) | 77·6% (71·8 to 82·8) | 93·5% (88·9 to 96·6) | 12·9% (7·7 to 18·3) | 15·9% (9·3 to 22·2) | 1·32 (1·18 to 1·48) | 0·89 (0·78 to 1·02) | 2·17 (1·90 to 2·48) | 1·48 (1·24 to 1·77) | 2·43 (2·00 to 2·95) |
| Cross-reacting serotypes | ||||||||||
| 6A | 50·3% (44·4 to 56·3) | 40·5% (34·2 to 47·1) | 69·2% (62·0 to 75·8) | 9·8% (2·6 to 16·9) | 28·7% (19·2 to 37·4) | 0·37 (0·34 to 0·41) | 0·31 (0·28 to 0·35) | 0·64 (0·55 to 0·73) | 1·19 (1·03 to 1·37) | 2·04 (1·71 to 2·43) |
| 19A | 68·2% (62·4 to 73·5) | 70·5% (64·2 to 76·2) | 85·9% (80·1 to 90·6) | −2·3% (−8·9 to 4·4) | 15·5% (7·6 to 22·9) | 0·56 (0·51 to 0·62) | 0·55 (0·49 to 0·62) | 0·93 (0·81 to 1·06) | 1·02 (0·88 to 1·19) | 1·68 (1·41 to 2·01) |
Data in parentheses are 95% CI, unless otherwise specified. Immunogenicity data are for 4 weeks after completion of the primary vaccination series. In their primary vaccination series, group A and B were both given three doses at ages 2, 3, and 4 months and their data are combined for the purpose of this analysis, group C were given two doses at ages 2 and 4 months, and group D were given two doses at ages 2 and 6 months. GMC=geometric mean concentration. PCV10=ten-valent pneumococcal conjugate vaccine.