Table 3.
Reference | Vaccine dose 1–3 | Vaccine dose 4 | Timepoint | N | rSBA ≥ 1 : 8 | rSBA ≥ 1 : 128 | GMT | |||
---|---|---|---|---|---|---|---|---|---|---|
% | [95% CI] | % | [95% CI] | Value | [95% CI] | |||||
rSBA-MenC | ||||||||||
| ||||||||||
Habermehl et al., 2010 [68] 2, 3, 4 + 12–18 months of age | Hib-MenCY-TT + DTPa-HBV-IPV | Hib-MenCY-TT + DTPa-HBV-IPV | PD3 | 70 | 100 | [94.9–100] | 95.7 | [88.0–99.1] | 1005.8 | [773.5–1308.0] |
Pre-D4 | 46 | 91.3 | [79.2–97.6] | 63.0 | [47.5–76.8] | 153.1 | [90.4–259.4] | |||
PD4 | 40 | 100 | [91.2–100] | 100 | [91.2–100] | 4762.6 | [3427.5–6617.7] | |||
MenC-CRM197 + DTPa-HBV-IPV/Hib | MenC-CRM197 + DTPa-HBV-IPV/Hib | PD3 | 71 | 100 | [94.9–100] | 100 | [94.9–100] | 3557.6 | [2978.8–4248.8] | |
Pre-D4 | 42 | 95.2 | [83.8–99.4] | 69.0 | [52.9–82.4] | 199.2 | [129.6–306.2] | |||
PD4 | 39 | 100 | [91.0–100] | 100 | [91.0–100] | 11819.3 | [8458.6–16515.2] | |||
| ||||||||||
Nolan et al., 2007 [81] 2, 4, 6 + 11–14 months of age | Hib-MenCY-TT + DTPa-HBV-IPV | Men-PS Challenge | PD3 | 74* | 100 | [94.8–100] | 98.6 | [92.2–100] | 1293.1 | [1027.7–1627.1] |
Pre-Ch | 80* | 97.4 | [90.8–99.7] | 78.9 | [68.1–87.5] | 265.5 | [197.8–356.3] | |||
Post-Ch | 73* | 100 | [94.8–100] | 98.6 | [92.2–100] | 1985.5 | [1542.6–2555.8] | |||
MenC-CRM197 + DTPa-HBV-IPV/Hib | Men-PS Challenge | PD3 | 77* | 100 | [95.1–100] | 98.6 | [92.7–100] | 1931.9 | [1541.2–2421.6] | |
Pre-Ch | 81* | 90.8 | [81.9–96.2] | 64.5 | [52.7–75.1] | 176.6 | [117.9–264.4] | |||
Post-Ch | 79* | 97.5 | [91.2–99.7] | 84.8 | [75.0–91.9] | 774.8 | [536.7–1118.5] | |||
| ||||||||||
Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age | Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV | Hib-MenCY-TT + MMR + VAR | PD3 | 287 | 99.0 | [97.0–99.8] | 94.4 | [91.1–96.8] | 805 | [700–925] |
Pre-D4 | 495 | 90.7 | [87.8–93.1] | 48.7 | [44.2–53.2] | 103 | [90.1–117] | |||
PD4 | 496 | 99.6 | [98.6–100] | 97.2 | [95.3–98.4] | 1697 | [1516–1900] | |||
MenC-CRM197 + Hib-TT + 7vCRM + DTPa-HBV-IPV | Hib-MenCY-TT + MMR + VAR | PD3 | 99 | 100 | [96.3–100] | 96.0 | [90.0–98.9] | 790 | [649–961] | |
Pre-D4 | 169 | 84.6 | [78.3–89.7] | 29.6 | [22.8–37.1] | 53.7 | [43.0–67.1] | |||
PD4 | 162 | 95.7 | [91.3–98.2] | 71.0 | [63.3–77.8] | 262 | [204–336] | |||
| ||||||||||
rSBA-MenY | ||||||||||
| ||||||||||
Habermehl et al., 2010 [68] 2, 3, 4 + 12–18 months of age | Hib-MenCY-TT + DTPa-HBV-IPV | Hib-MenCY-TT + DTPa-HBV-IPV | PD3 | 69 | 97.1 | [89.9–99.6] | 92.8 | [83.9–97.6] | 470.7 | [351.1–631.2] |
Pre-D4 | 45 | 86.7 | [73.2–94.9] | 60.0 | [44.3–74.3] | 103.2 | [64.6–164.9] | |||
PD4 | 40 | 100 | [91.2–100] | 100 | [91.2–100] | 1708.1 | [1313.3–2221.4] | |||
| ||||||||||
Nolan et al., 2007 [81] 2, 4, 6 + 11–14 months of age |
Hib-MenCY-TT + DTPa-HBV-IPV | Men-PS Challenge | PD3 | 74* | 98.5 | [92.0–100] | 95.5 | [87.5–99.1] | 843.5 | [640.1–1111.7] |
Pre-Ch | 80* | 89.2 | [79.8–95.2] | 60.8 | [48.8–72.0] | 114.7 | [80.0–164.4] | |||
Post-Ch | 73* | 100 | [94.7–100] | 100 | [94.7–100] | 1838.0 | [1427.9–2366.0] | |||
| ||||||||||
Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age |
Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV | Hib-MenCY-TT + MMR + VAR | PD3 | 288 | 99.7 | [98.1–100] | 91.7 | [87.9–94.6] | 728 | [636–835] |
Pre-D4 | 514 | 98.4 | [97.0–99.3] | 80.5 | [76.9–83.9] | 264 | [241–290] | |||
PD4 | 496 | 100 | [99.3–100] | 99.4 | [98.2–99.9] | 1987 | [1826–2161] |
N: numbers of subjects with available data, *N: numbers of subjects in the ATP Cohort, %: percentage of subjects with titre within the specified range, 95% CI: 95% confidence interval, GMT: Geometric Mean Titre, PD3: one month after dose 3 (ATP Cohort for Immunogenicity), Pre-D4: just prior dose 4 (ATP Cohort for Persistence), PD4: one month after dose 4 (ATP Cohort for Immunogenicity), Pre-Ch: just prior to meningococcal polysaccharide challenge (ATP Cohort for safety challenge phase), Post-Ch: one month after meningococcal polysaccharide challenge (ATP Cohort for Immunogenicity), Results of this table were previously published [68, 81, 84].