Each 0.5 mL dose of Liquid PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide)…
Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b…
As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.
As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Hib disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.
[V]accination should be delayed during the course of an acute febrile illness.
Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
[O]ne serious reaction (tracheitis) was reported…
Seizures occurred infrequently in both groups (9 occurred in vaccine recipients, 8 of whom also received DTP; 8 occurred in placebo recipients, 7 of whom also received DTP)…
In early clinical studies… urticaria was reported in two children, and thrombocytopenia was seen in one child. The use of Haemophilus b Polysaccharide Vaccines and another Haemophilus b Conjugate Vaccine has been associated with the following additional adverse effects: early onset Hib disease and Guillain-Barré syndrome.
Post-Marketing Adverse Reactions
– Lymphadenopathy
– Angioedema
– Febrile seizures
– Sterile injection site abscess