Initial U.S. Approval: 2009
HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b.
Serious Adverse Reactions
[C]onvulsion on Day 14 after Dose 1… new onset febrile seizure on Day 1 after Dose 4… bilateral pneumonia 9 days post-vaccination…
Postmarketing Experience
– Extensive swelling of the vaccinated limb, injection site induration.
– Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema.
– Convulsions (with or without fever), hypotonic-hyporesponsive episode (i.e., sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis), somnolence, syncope, or vasovagal responses to injection.
– Apnea
– Rash, urticaria.
HIBERIX contains Haemophilus b capsular polysaccharide… grown in a synthetic medium…
…tetanus toxin… grown in a semi-synthetic medium, is detoxified with formaldehyde and purified. The capsular polysaccharide is covalently bound to the tetanus toxoid.
Most strains of H. influenzae that cause invasive disease are type b. H. influenzae type b can cause invasive disease such as sepsis and meningitis.
HIBERIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.