HIB (PEDVAXHIB) VACCINE

VACCINE USAGE: 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.

As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.

IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE

No clinical data are available from controlled studies comparing booster immunization with HIBERIX and a US-licensed Haemophilus b Conjugate Vaccine.

VACCINE DOSAGE: 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.

VACCINE INGEDIENTS: aluminum hydroxyphosphate sulfate, ethanol, enzymes, phenol, detergent, complex fermentation medium.

ADVERSE VACCINE REACTIONS: Guillain-Barre syndrome, lymphadenopathy, hypersensitivity, angioedema, febrile seizures, sterile injection site abscess.