Table 4:
Geometric mean titres and geometric mean ratios of human complement serum bactericidal activity, intention-to-treat population
| Strain (antigen assessed) | Group | Geometric mean titres (95% CI) | Geometric mean ratios (95% CI) | |||
|---|---|---|---|---|---|---|
|
|
|
|||||
| At baseline | At 1 mo | At 3 mo | 1 mo:baseline | 3 mo:baseline | ||
| 44/76-SL (fHbp) | 4CMenB 246-12* | 5.3 (3.3–8.8) | 89 (68–116) | NA | 17 (11–27) | NA |
|
| ||||||
| rMenB246-12† | 3.2 (2.4–4.5) | 99 (62–158) | NA | 30 (18–50) | NA | |
|
| ||||||
| 4CMenB-12‡ | 3.5 (0.9–14) | 76 (27–210) | 145 (74–283) | 21 (4.2–110) | 42 (12–147) | |
|
| ||||||
| rMenB-12§ | 3.6 (2.1–6.2) | 94 (46–192) | 127 (81–200) | 27 (13–57) | 37 (21–64) | |
|
| ||||||
| Control¶ | 4.2 (3.2–5.6) | 12 (8.0–19) | 88 (66–117) | 3.2 (2.1–5.0) | 20 (15–28) | |
|
| ||||||
| 5/99 (NadA) | 4CMenB246-12* | 28 (9.4–83) | 1708 (774–3771) | NA | 70 (29–167) | NA |
|
| ||||||
| rMenB246-12† | 5.1 (2.3–11) | 778 (461–1311) | NA | 148 (90–245) | NA | |
|
| ||||||
| 4CMenB-12‡ | 1.0 (1.0–1.0) | 509 (178–1456) | 2413 (988–5892) | 509 (178–1456) | 2413 (988–5892) | |
|
| ||||||
| rMenB-12§ | 9.6 (4.2–22) | 2379 (995–5685) | 5240 (3216–8538) | 299 (129–694) | 501 (143–1748) | |
|
| ||||||
| Control¶ | 1.1 (0.7–1.8) | 22 (13–36) | 1019 (760–1367) | 19 (10–36) | 910 (594–1394) | |
|
| ||||||
| NZ98/254 (PorA) | 4CMenB246-12* | 2.8 (1.4–5.6) | 47 (20–107) | NA | 20 (7.7–51) | NA |
|
| ||||||
| rMenB246-12† | 1.1 (1.0–1.2) | 1.6 (1.0–2.6) | NA | 1.5 (1.0–2.4) | NA | |
|
| ||||||
| 4CMenB-12‡ | 1.0 (1.0–1.0) | 148 (66–330) | 65 (22–189) | 148 (66–330) | 65 (22–189) | |
|
| ||||||
| rMenB-12§ | 1.2 (0.9–1.7) | 1.7 (0.8–3.8) | 1.9 (0.9–3.7) | 1.4 (0.6–3.1) | 1.5 (0.7–3.1) | |
|
| ||||||
| Control¶ | 1.0 (1.0–1.0) | 7.7 (4.6–13) | 47 (31–72) | 7.6 (4.5–13) | 47 (31–74) | |
|
| ||||||
| M10713 (NHBA) | 4CMenB246-12* | 5.3 (2.3–12) | 39 (22–69) | NA | 10 (4.3–24) | NA |
|
| ||||||
| rMenB246-12† | 9.2 (4.9–17) | 38 (24–59) | NA | 4.7 (2.3–9.4) | NA | |
|
| ||||||
| 4CMenB-12‡ | 3.0 (0.8–12) | 30 (9.5–96) | 36 (21–61) | 10 (2.0–49) | 12 (3.0–48) | |
|
| ||||||
| rMenB-12§ | 3.3 (1.6–6.6) | 35 (19–67) | 21 (7.4–60) | 11 (4.2–30) | 5.5 (1.5–20) | |
|
| ||||||
| Control¶ | 8.8 (5.2–15) | 11 (6.7–19) | 33 (22–51) | 1.3 (0.9–1.8) | 3.9 (2.1–7.2) | |
|
| ||||||
| M00-242922 | 4CMenB246-12* | 3.5 (1.7–7.0) | 64 (27–155) | NA | 22 (8.3–56) | NA |
|
| ||||||
| rMenB246-12† | 1.6 (1.2–2.2) | 7.0 (4.4–11) | NA | 4.6 (2.9–7.5) | NA | |
|
| ||||||
| 4CMenB-12‡ | 1.0 (1.0–1.0) | 206 (33–1308) | 53 (21–131) | 206 (33–1308) | 53 (21–131) | |
|
| ||||||
| rMenB-12§ | 1.2 (0.9–1.7) | 4.6 (1.6–13) | 3.0 (1.6–5.7) | 3.8 (1.5–9.6) | 2.4 (1.2–5.0) | |
|
| ||||||
| Control¶ | 1.4 (1.2–1.8) | 3.6 (2.6–5.2) | 31 (22–44) | 2.7 (2.0–3.8) | 23 (16–34) | |
|
| ||||||
| M01-240101 | 4CMenB246-12* | 7.6 (4.3–13) | 159 (80–314) | NA | 20 (6.8–59) | NA |
|
| ||||||
| rMenB246-12† | 7.0 (4.0–12) | 76 (40–143) | NA | 11 (5.7–23) | NA | |
|
| ||||||
| 4CMenB-12‡ | 4.0 (1.7–9.2) | 59 (14–248) | 92 (40–213) | 16 (2.4–105) | 23 (5.4–100) | |
|
| ||||||
| rMenB-12§ | 12 (3.4–41) | 82 (35–190) | 43 (21–89) | 6.9 (2.8–17) | 4.2 (1.1–16) | |
|
| ||||||
| Control¶ | 6.6 (4.4–9.9) | 87 (46–165) | 207 (120–358) | 12 (6.5–23) | 33 (17–64) | |
|
| ||||||
| M01-240355 | 4CMenB246-12* | 1.2 (0.8–1.7) | 5.0 (2.6–9.3) | NA | 4.2 (2.2–8.2) | NA |
|
| ||||||
| rMenB246-12† | 1.8 (1.2–2.8) | 1.9 (1.3–2.8) | NA | 1.0 (0.7–1.6) | NA | |
|
| ||||||
| 4CMenB-12‡ | 1.7 (0.9–3.0) | 5.9 (3.1–11) | 5.5 (1.8–17) | 3.3 (1.3–8.5) | 3.3 (1.4–7.7) | |
|
| ||||||
| rMenB-12§ | 1.4 (0.8–2.4) | 1.7 (1.0–2.9) | 1.3 (0.8–2.0) | 1.2 (0.8–1.7) | 0.9 (0.6–1.3) | |
|
| ||||||
| Control¶ | 1.5 (1.2–2.0) | 2.5 (1.5–4.1) | 6.2 (3.6–11) | 1.7 (1.2–2.5) | 4.1 (2.7–6.3) | |
|
| ||||||
| M01-240364 | 4CMenB246-12* | 17 (8.3–36) | 134 (56–322) | NA | 8.3 (3.0–23) | NA |
|
| ||||||
| rMenB246-12† | 6.5 (3.6–12) | 41 (17–96) | NA | 6.2 (2.6–15) | NA | |
|
| ||||||
| 4CMenB-12‡ | 5.0 (1.6–16) | 52 (14–193) | 107 (26–443) | 8.2 (1.6–43) | 21 (5.0–91) | |
|
| ||||||
| rMenB-12§ | 12 (4.9–31) | 275 (144–528) | 616 (191–1980) | 22 (11–44) | 56 (18–172) | |
|
| ||||||
| Control¶ | 9.4 (6.5–14) | 11 (7.6–16) | 104 (68–159) | 1.2 (0.8–1.7) | 11 (6.4–18) | |
CI = confidence interval, fHbp = factor H binding protein, hSBA = human complement serum bactericidal activity, NA = not applicable, NadA = Neisseria adhesin A, NHBA = Neisseria heparin binding antigen, PorA = porin A.
*
Participants who received 4 doses of 4CMenB vaccine at 2, 4, 6 and 12 months.
†
Participants who received 4 doses of rMenB vaccine at 2, 4, 6 and 12 months.
‡
Participants who received 1 dose of 4CMenB at 12 months.
§
Participants who received 1 dose of rMenB vaccine at 12 months.
¶
Participants with no previous exposure to 4CMenB or rMenB vaccines.