TABLE 2.

Serum anti-PRP antibody concentrations in four clinical trials at postprimary and booster time pointsa

StudyGroupNo. of subjects testedGMC (μg/ml) (95% CI) for:Fold increase
IgGRABA IgIgGTotal Ig
United States
    PostprimaryDTPa + HBV + OPV + Hib*534.27 (2.76-6.6)6.21 (4.276-9.023)
DTPa-HBV-IPV/Hib512.1 (1.51-2.92)3.27 (2.481-4.321)
    PostboosterDTPa + Hib*3333.63 (20.68-54.70)28.37 (17.612-45.716)7.874.56
DTPa/Hib3342.89 (29.71-61.92)26.52 (18.433-38.148)20.428.09
Germany A
    PostprimaryDTPa + Hib535.74 (4.07-8.1)8.93 (6.74-11.8)
DTPa/Hib641.13 (0.81-1.57)2.46 (1.77-3.42)
    PostboosterDTPa + Hib3573.5 (46.4-117)89.4 (56.6-141)12.810.01
DTPa/Hib4036.4 (22.8-58.4)38.1 (25.8-56.4)32.215.5
Germany B
    PostprimaryDTPa-HBV + Hib217.79 (4.53-13.41)
DTPa-HBV/Hib251.67 (1.11-2.53)
    PreboosterDTPa-HBV + Hib210.754 (0.42-1.36)
DTPa-HBV/Hib250.21 (0.15-0.29)
    Postboosterdtpa-HBV + PRP2135.28 (15.04-82.73)4.53
dtpa-HBV/PRP259.63 (4.84-19.15)5.77
Myanmar
    PostprimaryDTPw-HBV/Hib2.52520.32 (12.968-31.864)
DTPw-HBV/Hib2518.67 (12.331-28.270)
    PostboosterDTPw-HBV/Hib2.52544.10 (28.062-69.309)2.17
DTPw-HBV/Hib2549.91 (27.716-79.390)2.67
  • a Blood samples were collected 1 month after the three-dose primary series and 4 to 6 weeks after the booster dose. CI, confidence interval; Hib2.5, Hib vaccine containing 2.5 μg PRP conjugated to TT; OPV, oral poliovirus vaccine. *, OmniHIB.