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ActHIB

Clinical Pharmacology
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Clinical Pharmacology

ActHIB

** Seroconversion after the recommended 2-dose primary immunization series is shown.

† Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate)

N/A Not applicable in this comparison trial although third dose data have been published. 16,17

Native American populations have had high rates of H influenzae type b disease and have been observed to have low immune responses to Haemophilus b conjugate vaccines. Following three doses of ActHIB® at six weeks, four and six months of age, 75% of Native Americans in Alaska showed an anti-PRP antibody titer of >1.0 µg/mL. 18

Children 12 to 24 months of age who had not previously received Haemophilus b conjugate vaccination were immunized with a single dose of ActHIB®. GMT anti-PRP antibody responses were 5.12 µg/mL (90% responding with >1.0 µg/mL) for children 12 to 15 months of age and 4.4 µg/mL (82% responding with <1.0 µg/mL) for children 17 to 24 months of age. 18

These trials demonstrated that ActHIB® consistently conferred an anti-PRP antibody response previously shown to correlate with protection, when administered either as a regimen of three doses at least four to eight weeks apart in infants 2 to 6 months of age or as a single dose in children 12 months of age and older. 18

ActHIB® has been found to be immunogenic in children with sickle cell anemia, a condition which may cause increased susceptibility to Haemophilus b disease. Two doses of ActHIB® given at two-month intervals induced anti-PRP antibody titers of >1.0 µg/mL in 89% of these children with a mean age of 11 months. This is comparable to anti-PRP antibody levels demonstrated in normal children of similar age following two doses of ActHIB®. 19

ActHIB® COMBINED WITH WHOLE-CELL PERTUSSIS VACCINE (DTP) BY RECONSTITUTION FOR PRIMARY IMMUNIZATION

Comparative clinical trials demonstrated that a similar anti-PRP response was achieved in infants as young as 2 months old when one dose of AvP whole-cell DTP vaccine was used to reconstitute lyophilized ActHIB® (Table 3). 14,18

TABLE 3 18

ANTI-PRP RESPONSES IN 2-MONTH-OLD INFANTS FOLLOWING IMMUNIZATION WITH

ActHIB ® COMBINED WITH CONNAUGHT LABORATORIES, INC. DTP BY RECONSTITUTION

GEOMETRIC MEAN TITER (GMT)

(µg/mL)

STUDY SITE

N*

Pre-Immunization

Post Second Immunization

Post Third Immunization

Post Third Immunization%>1.0 µg/ mL

US
Brand Name: ActHIB
Generic Name: Haemophilus b Conjugate Vaccine
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