Indication
PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae
type b in infants and children 2 to 71 months of age. PedvaxHIB should not be used in infants <6 weeks of age.
PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.
PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.
PedvaxHIB is administered in a 2-dose primary regimen before 14 months of age. Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.
Select Safety Information
PedvaxHIB is contraindicated in patients with hypersensitivity
to any component of the vaccine. Persons who develop symptoms suggestive
of hypersensitivity after an injection should not receive further
injections of the vaccine.
Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.
The most frequently reported (>1%) adverse reactions,
without regard to causality, were fever (>101°F), irritability,
sleepiness, injection-site pain/soreness, injection-site erythema (<2.5 cm diameter), injection-site swelling/induration (<2.5 cm diameter),
unusual high-pitched crying, prolonged crying (>4 hours), diarrhea,
vomiting, crying, pain, otitis media, rash, and upper respiratory
infection.
As with any vaccine, vaccination may not result in a protective
antibody response in all individuals given the vaccine. As with other
vaccines, PedvaxHIB may not induce protective antibody levels
immediately following vaccination.
Before administering PedvaxHIB, please read the Prescribing Information.
