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Pedvax HIB

Clinical Pharmacology
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Clinical Pharmacology

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

Brand Name: Pedvax HIB
Generic Name: Haemophilus b Conjugate Vaccine

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