TABLE 2

Immune Responses to the 7 Common Serotypes After the Infant Vaccination Series

Immune Measurement46B9V1418C19F23F
% of responders according to antipolysaccharide IgG (95% CI)a
    PCV1394.4 (90.9 to 96.9)b87.3 (82.5 to 91.1)90.5 (86.2 to 93.8)97.6 (94.9 to 99.1)96.8 (93.8 to 98.6)98.0 (95.4 to 99.4)90.5 (86.2 to 93.8)
    PCV798.0 (95.4 to 99.4)92.8 (88.9 to 95.7)98.4 (96.0 to 99.6)97.2 (94.4 to 98.9)98.4 (96.0 to 99.6)97.6 (94.9 to 99.1)94.0 (90.4 to 96.6)
    Differencec−3.6 (−7.3 to −0.1)d−5.5 (−10.9 to −0.1)−7.9 (−12.4 to −4.0)0.4 (−2.7 to 3.5)−1.6 (−4.7 to 1.2)0.4 (−2.4 to 3.4)−3.6 (−8.5 to 1.2)
Antipolysaccharide IgG GMC (95% CI), μg/mLe
    PCV131.31 (1.19 to 1.45)f2.10 (1.77 to 2.49)0.98 (0.89 to 1.08)4.74 (4.18 to 5.39)1.37 (1.24 to 1.52)1.85 (1.69 to 2.04)1.33 (1.17 to 1.51)
    PCV71.93 (1.75 to 2.13)3.14 (2.64 to 3.74)1.40 (1.27 to 1.55)5.67 (5.02 to 6.40)1.79 (1.63 to 1.96)2.24 (2.01 to 2.50)1.90 (1.68 to 2.15)
    Ratiog0.68 (0.59 to 0.78)h0.67 (0.52 to 0.85)0.70 (0.61 to 0.80)0.84 (0.70 to 1.00)0.77 (0.67 to 0.88)0.83 (0.72 to 0.96)0.70 (0.59 to 0.84)
OPA titer, % ≥1:8 (95% CI)i
    PCV1397.8 (92.4 to 99.7)j98.9 (94.2 to 100)100 (96.1 to 100)100 (96.2 to 100)100 (96.2 to 100)90.4 (82.6 to 95.5)98.9 (94.2 to 100)
    PCV798.9 (94.1 to 100)100 (96.2 to 100)98.9 (94.2 to 100)100 (96.2 to 100)100 (96.2 to 100)92.6 (85.3 to 97.0)98.9 (94.2 to 100)
OPA GMT (95% CI)i
    PCV13359 (276 to 468)k1055 (817 to 1361)4035 (2933 to 5553)1240 (935 to 1646)276 (210 to 361)54 (40 to 74)791 (605 to 1034)
    PCV7536 (421 to 681)1514 (1207 to 1899)3259 (2288 to 4641)1481 (1133 to 1934)376 (292 to 484)45 (34 to 60)924 (709 to 1204)
  • a The proportion of subjects with antipolysaccharide IgG concentrations of ≥0.35 μg/mL (see text).

  • b Exact 2-sided CI is based on the observed proportion of subjects.

  • c Difference in proportions, PCV13–PCV7, expressed as a percentage.

  • d Exact 2-sided CI for the difference in proportions, PCV13–PCV7, is expressed as a percentage. Noninferiority was met if the lower limit of the 2-sided CI was greater than −10.0.

  • e GMCs were calculated by using all subjects with available data for the specified blood draw.

  • f CIs are back-transformations of a CI based on the Student's t test distribution for the mean logarithm of the concentrations.

  • g Ratio of GMCs; PCV13/PCV7.

  • h Exact 2-sided 95% CI of ratios. Noninferiority was met if the lower limit of the 2-sided CI was >0.5.

  • i Number of subjects with a determinate antibody titer for the specified serotype ranged from 89 to 94.

  • j Exact 2-sided CI is based on the observed proportion of subjects.

  • k CIs are back-transformations of a CI based on the Student's t distribution for the mean logarithm of the titers.