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Pedvax HIB
Clinical Pharmacology
Pedvax HIB
A booster dose of PedvaxHIB is required in infants who complete the primary two-dose regimen before 12 months of age. This booster dose will help maintain antibody levels during the first two years of life when children are at highest risk for invasive Hib disease. (See TABLE 2 and DOSAGE AND ADMINISTRATION.)
In four United States studies, antibody responses to lyophilized PedvaxHIB were evaluated in several subpopulations of infants initially vaccinated between 2 to 3 months of age. (See TABLE 3.)
TABLE 3
Antibody Responses* After Two Doses of Lyophilized PedvaxHIB Among Infants Initially
Vaccinated at 2–3 Months of Age By Racial/Ethnic Group
| Racial/Ethnic Groups |
No. of Subjects | LYOPHILIZED | Anti-PRP GMT (mcg/mL) | |
| % Subjects With Anti-PRP | ||||
| > 0.15 mcg/mL | > 1.0 mcg/mL | |||
| Native American† | 54 | 96 | 70 | 2.47 |
| Caucasian | 201 | 99 | 82 | 3.52 |
| Hispanic | 76 | 99 | 88 | 3.54 |
| Black | 23 | 100 | 96 | 5.40 |
| * One month after the second dose † Apache and Navajo |
||||
In two United States studies, antibody responses to Liquid PedvaxHIB were evaluated in several subpopulations of infants initially vaccinated between 2 to 3 months of age. (See TABLE 4.)
TABLE 4
Antibody Responses* After Two Doses of Liquid PedvaxHIB Among Infants Initially
Vaccinated at 2–3 Months of Age By Racial/Ethnic Group
| Racial/Ethnic Groups | No. of Subjects |
LIQUID | Anti-PRP GMT (mcg/mL) |
|
| % Subjects With Anti-PRP | ||||
| > 0.15 mcg/mL | > 1.0 mcg/mL | |||
| Native American** | 90 | 97 | 78 | 2.76 |
| Caucasian | 143 | 94 | 72 | 2.16 |
| Hispanic | 184 | 98 | 85 | 4.34 |
| Black | 18 | 100 | 94 | 7.58 |
| * One month after the second dose ** Apache and Navajo |
||||
Antibodies to the OMPC of N. meningitidis have been demonstrated in vaccinee sera, but the clinical relevance of these antibodies has not been established.33
Interchangeability of Licensed Haemophilus b Conjugate Vaccines and PedvaxHIB
Published studies have examined the interchangeability of other licensed Haemophilus b Conjugate Vaccines and PedvaxHIB.42,43,44,45,52 According to the American Academy of Pediatrics, excellent immune responses have been achieved when different vaccines have been interchanged in the primary series. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b Conjugate Vaccines for the booster dose.52
Use with Other Vaccines
Generic Name: Haemophilus b Conjugate Vaccine
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