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ActHIB

Clinical Pharmacology
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Clinical Pharmacology

Two clinical trials supported by the National Institutes of Health (NIH) have compared the anti-PRP antibody responses to three Haemophilus b conjugate vaccines in racially mixed populations of children. These studies were done in Tennessee 16 (Table 1) and in Minnesota, Missouri and Texas 17 (Table 2) in infants immunized with ActHIB® and other Haemophilus b conjugate vaccines at 2, 4 and 6 months of age. All Haemophilus b conjugate vaccines were administered concomitantly with Poliovirus Vaccine Live Oral and DTP vaccines at separate sites.

TABLE 1 16

ANTI-PRP ANTIBODY RESPONSES IN 2-MONTH-OLD INFANTS NIH TRIAL IN TENNESSEE

GEOMETRIC MEAN TITER (GMT)

(µg/ mL)

VACCINE

N*

Pre-Immunization

Post Second Immunization

Post Third Immunization

Post Third Immunization %>1.0µg/mL

PRP-T (ActHIB® )

65

0.10

0.30

3.64

83%

PRP-OMP (PedvaxHIB®)

64

0.11

0.84

N/A

50%**

HbOC (HibTITER® )

61

0.07

0.13

3.08

Brand Name: ActHIB
Generic Name: Haemophilus b Conjugate Vaccine
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