Initial U.S. Approval: 1993
ActHIB is a vaccine indicated for the prevention of invasive disease caused by Haemophilus influenzae type b.
More than 7,000 infants and young children (≤2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions. [No further report on the other 5,936 trial subjects.]
[W]ithin 30 days… (3.4%) participants experienced a serious adverse event (SAE).
Postmarketing Experience
– Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
– Convulsions, syncope
– Extensive limb swelling, peripheral edema, pruritus, rash (including generalized rash)
The vaccine consists of the Haemophilus influenzae type b… grown in a semi-synthetic medium, covalently bound to tetanus toxoid.
The tetanus toxoid… culture medium contains milk-derived raw materials (casein derivatives).
Most strains of H. influenzae that cause invasive disease (e.g., sepsis and meningitis) are H. influenzae type b.
ActHIB vaccine has not been evaluated for its carcinogenic or mutagenic potential or impairment of male fertility.