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ActHIB

Clinical Pharmacology
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Clinical Pharmacology

45

0.13

0.55

4.49

91

US

135

0.12

0.43

4.46

85

Chile

94

0.09

4.31

6.94

96

* N=Number of Children

Antibody responses to diphtheria, tetanus and pertussis antigens were also measured in this trial. Post dose three antibody responses to all measured vaccine antigens were similar, within each study, when infants who received the combined vaccine were compared to infants who received whole-cell DTP and ActHIB® separately. Interference with the antibody response to the pertussis component has been suggested with a DTP vaccine unlicensed in the US. 20 Percentages of subjects achieving antibody titers over 1 µg/mL and GMT to PRP in 2-month-old infants following immunization with ActHIB® combined with AvP DTP by reconstitution was similar when compared to infants who received DTP and ActHIB® separately (84% versus 85% and 4.3 µg/mL versus 4.8 µg/mL). 14,18

TriHIBitTM, ActHIB® COMBINED WITH TRIPEDIA® VACCINE BY RECONSTITUTION FOR BOOSTER DOSE Randomized comparative clinical trials demonstrated that the anti-PRP response achieved in 15 to 20 month old children after one dose of TriHIBitTM, Tripedia® and ActHIB® combination vaccine, was similar to that achieved when the two vaccines were given concomitantly at different sites with separate needles and syringes (Table 4). 18 All children had received three doses of a Haemophilus b conjugate vaccine (HibTITER® or ActHIB®) and three doses of a whole-cell DTP vaccine prior to entry into this clinical trial.

TABLE 4 18

ANTI-PRP RESPONSES IN 15 TO 20-MONTH-OLD CHILDREN FOLLOWING IMMUNIZATION

With TriHIBitTM COMPARED TO ActHIB® AND TRIPEDIA GIVEN CONCOMITANTLY AT SEPARATE SITES

IMMUNOGENICITY

 
Brand Name: ActHIB
Generic Name: Haemophilus b Conjugate Vaccine
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