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Pharmacology: Pharmacodynamics: Primary vaccination: Table 1 presents the immunogenicity results from 4 clinical trials in which infants in the United States, Europe, South America and South-East Asia received a 3-dose primary vaccination with Hiberix in the first 6 months of life starting from 6 weeks of age. Varying vaccination schedules were evaluated and Hiberix was co-administered with other routinely recommended vaccines.
Hiberix was immunogenic in all 3-dose schedules studied. Anti-PRP concentration of ≥0.15 μg/ml (a level indicative for short-term protection) was obtained in 96.6-99.4% of infants one month after the completion of the vaccination course. (See Table 1.)
Click on icon to see table/diagram/imageIn addition, in unprimed toddlers aged 22-26 months (study Hib-036) who received a single dose of Hiberix co-administered with DTPa, 100% of subjects [N= 54, 95 % CI (93.4;100)] achieved anti-PRP concentrations ≥ 1.0 μg/ml one month after vaccination. These data support a single dose of Hiberix in children aged from 1 year and above.
Booster vaccination: Antibody responses to booster vaccination with Hiberix after a 3 dose priming schedule are presented in Table 2. One month after the booster dose, all children had anti-PRP concentrations ≥ 0.15 μg/ml and at least 99.1% had anti-PRP concentrations ≥ 1.0 μg/ml, a concentration correlated with long term immunity to Hib (Table 2). (See Table 2.)
Click on icon to see table/diagram/imageClinical Studies: See Pharmacodynamics as previously mentioned.
Pharmacokinetics: Evaluation of pharmacokinetic properties is not required for vaccines.
