Table 3.
GMTs, GMFR, and proportion of participants with ≥4-fold rise in serotype-specific OPA antibodies from pre-vaccination to 30 days after vaccination with V114
| Serotype | Outcome | Concomitant (N = 599) |
Non-concomitant (N = 598) |
||||
|---|---|---|---|---|---|---|---|
| n | Response | 95% CI | n | Response | 95% CI | ||
| 1 | GMT (Day 1) | 559 | 12.4 | 11.0–14.1 | 549 | 12.3 | 10.9–14.0 |
| GMT (Day 30) | 551 | 141.5 | 120.9–165.5 | 523 | 209.1 | 178.1–245.5 | |
| GMFR | 517 | 8.0 | 6.8–9.3 | 505 | 11.8 | 10.1–13.9 | |
| ≥4-fold rise, % (n) | 517 | 57.8 (299) | 53.4–62.1 | 505 | 66.3 (335) | 62.0–70.5 | |
| 3 | GMT (Day 1) | 546 | 19.9 | 18.2–21.9 | 538 | 20.3 | 18.4–22.4 |
| GMT (Day 30) | 540 | 137.3 | 123.0–153.2 | 521 | 148.2 | 132.7–165.4 | |
| GMFR | 495 | 4.7 | 4.3–5.3 | 493 | 4.8 | 4.3–5.4 | |
| ≥4-fold rise, % (n) | 495 | 54.7 (271) | 50.2–59.2 | 493 | 54.8 (270) | 50.3–59.2 | |
| 4 | GMT (Day 1) | 519 | 67.5 | 58.0–78.4 | 524 | 66.2 | 56.8–77.0 |
| GMT (Day 30) | 543 | 910.3 | 796.1–1,040.9 | 513 | 1,074.4 | 926.7–1,245.5 | |
| GMFR | 471 | 9.4 | 8.0–11.0 | 476 | 11.5 | 9.7–13.6 | |
| ≥4-fold rise, % (n) | 471 | 63.1 (297) | 58.5–67.4 | 476 | 66.4 (316) | 61.9–70.6 | |
| 5 | GMT (Day 1) | 560 | 33.6 | 29.8–38.0 | 547 | 33.0 | 29.1–37.4 |
| GMT (Day 30) | 549 | 402.1 | 342.0–472.7 | 523 | 494.4 | 419.2–583.0 | |
| GMFR | 516 | 8.1 | 7.0–9.4 | 503 | 10.2 | 8.7–12.0 | |
| ≥4-fold rise, % (n) | 516 | 60.5 (312) | 56.1–64.7 | 503 | 63.4 (319) | 59.0–67.6 | |
| 6A | GMT (Day 1) | 498 | 366.4 | 325.4–412.6 | 499 | 426.1 | 376.5–482.2 |
| GMT (Day 30) | 526 | 5,419.5 | 4,759.9–6,170.5 | 513 | 6,812.6 | 5,998.4–7,737.3 | |
| GMFR | 443 | 10.5 | 9.1–12.1 | 451 | 12.1 | 10.5–14.0 | |
| ≥4-fold rise, % (n) | 443 | 71.1 (315) | 66.6–75.3 | 451 | 75.6 (341) | 71.4–79.5 | |
| 6B | GMT (Day 1) | 512 | 157.5 | 131.7–188.3 | 524 | 166.9 | 139.7–199.5 |
| GMT (Day 30) | 539 | 3,912.9 | 3,456.6–4,429.5 | 520 | 4,408.7 | 3,870.5–5,021.7 | |
| GMFR | 466 | 17.6 | 14.8–20.9 | 481 | 20.5 | 17.3–24.4 | |
| ≥4-fold rise, % (n) | 466 | 72.5 (338) | 68.2–76.5 | 481 | 76.1 (366) | 72.0–79.8 | |
| 7F | GMT (Day 1) | 535 | 301.4 | 256.6–354.1 | 520 | 418.9 | 353.6–496.3 |
| GMT (Day 30) | 545 | 3,469.7 | 3,148.8–3,823.2 | 524 | 4,244.0 | 3,799.0–4,741.1 | |
| GMFR | 492 | 9.2 | 7.9–10.8 | 484 | 8.0 | 6.9–9.4 | |
| ≥4-fold rise, % (n) | 492 | 63.0 (310) | 58.6–67.3 | 484 | 59.7 (289) | 55.2–64.1 | |
| 9V | GMT (Day 1) | 540 | 384.8 | 341.2–434.0 | 528 | 450.8 | 396.6–512.3 |
| GMT (Day 30) | 534 | 2,831.9 | 2,560.8–3,131.7 | 521 | 2,900.8 | 2,592.6–3,245.8 | |
| GMFR | 483 | 5.8 | 5.1–6.6 | 483 | 5.3 | 4.6–6.1 | |
| ≥4-fold rise, % (n) | 483 | 54.9 (265) | 50.3–59.4 | 483 | 53.4 (258) | 48.9–57.9 | |
| 14 | GMT (Day 1) | 542 | 440.3 | 379.2–511.3 | 540 | 475.5 | 407.3–555.2 |
| GMT (Day 30) | 545 | 2,021.1 | 1,777.9–2,297.6 | 518 | 2,258.4 | 1,982.4–2,572.9 | |
| GMFR | 498 | 3.9 | 3.3–4.4 | 491 | 4.1 | 3.5–4.7 | |
| ≥4-fold rise, % (n) | 498 | 38.6 (192) | 34.3–43.0 | 491 | 40.9 (201) | 36.6–45.4 | |
| 18C | GMT (Day 1) | 545 | 226.9 | 200.7–256.4 | 535 | 246.3 | 217.8–278.5 |
| GMT (Day 30) | 549 | 3,000.9 | 2,686.1–3,352.6 | 522 | 3,807.1 | 3,402.5–4,259.8 | |
| GMFR | 503 | 9.8 | 8.6–11.2 | 491 | 11.6 | 10.0–13.4 | |
| ≥4-fold rise, % (n) | 503 | 67.4 (339) | 63.1–71.5 | 491 | 70.3 (345) | 66.0–74.3 | |
| 19A | GMT (Day 1) | 533 | 480.2 | 418.5–550.9 | 522 | 580.1 | 509.8–660.2 |
| GMT (Day 30) | 538 | 3,158.2 | 2,872.4–3,472.3 | 518 | 3,884.3 | 3,516.1–4,291.1 | |
| GMFR | 482 | 6.2 | 5.4–7.2 | 476 | 6.6 | 5.7–7.6 | |
| ≥4-fold rise, % (n) | 482 | 53.7 (259) | 49.2–58.3 | 476 | 57.1 (272) | 52.6–61.6 | |
| 19F | GMT (Day 1) | 534 | 394.9 | 349.6–446.1 | 536 | 463.7 | 409.9–524.5 |
| GMT (Day 30) | 547 | 2,462.4 | 2,222.2–2,728.7 | 522 | 2,518.7 | 2,261.9–2,804.6 | |
| GMFR | 490 | 5.2 | 4.6–5.9 | 492 | 4.7 | 4.2–5.4 | |
| ≥4-fold rise, % (n) | 490 | 53.7 (263) | 49.1–58.2 | 492 | 48.8 (240) | 44.3–53.3 | |
| 22F | GMT (Day 1) | 481 | 101.5 | 81.2–126.8 | 490 | 100.4 | 80.0–125.8 |
| GMT (Day 30) | 543 | 2,250.0 | 1,974.7–2,563.8 | 516 | 2,900.1 | 2,535.5–3,317.3 | |
| GMFR | 438 | 15.9 | 12.8–19.8 | 446 | 20.6 | 16.4–25.9 | |
| ≥4-fold rise, % (n) | 438 | 64.2 (281) | 59.5–68.7 | 446 | 67.5 (301) | 62.9–71.8 | |
| 23F | GMT (Day 1) | 471 | 110.2 | 93.3–130.1 | 473 | 165.7 | 138.3–198.6 |
| GMT (Day 30) | 540 | 2,130.1 | 1,853.1–2,448.4 | 519 | 2,714.1 | 2,360.1–3,121.2 | |
| GMFR | 427 | 13.9 | 11.7–16.6 | 436 | 11.9 | 9.9–14.3 | |
| ≥4-fold rise, % (n) | 427 | 73.1 (312) | 68.6–77.2 | 436 | 67.2 (293) | 62.6–71.6 | |
| 33F | GMT (Day 1) | 555 | 1,791.9 | 1,581.0–2,030.9 | 537 | 2,131.4 | 1,880.8–2,415.4 |
| GMT (Day 30) | 547 | 7,879.3 | 7,041.9–8,816.4 | 518 | 10,077.9 | 8,946.7–11,352.2 | |
| GMFR | 510 | 4.3 | 3.8–4.9 | 488 | 4.6 | 4.0–5.3 | |
| ≥4-fold rise, % (n) | 510 | 44.1 (225) | 39.8–48.5 | 488 | 44.9 (219) | 40.4–49.4 | |
CI, confidence interval; GMFR, geometric mean fold rise; GMT, geometric mean titer; OPA, opsonophagocytic activity; V114, 15-valent pneumococcal conjugate vaccine. Within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution for continuous endpoints and using the exact binomial method proposed by Clopper and Pearson for dichotomous endpoints.