ActHIB

Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

ActHIB vaccine is a sterile, lyophilized powder to be reconstituted with saline diluent (0.4% Sodium Chloride) for intramuscular administration only. The vaccine consists of the Haemophilus influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate, PRP), a high-molecular weight polymer prepared from the H. influenzae type b strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid.

Advisory Board:

Data regarding the safety and immunogenicity of ActHlB TM when reconstituted with CLI DTP were presented and discussed at the October 28, 1992 Vaccines and Related Biological Products Advisory Committee meeting. Data on use of TripediaTM to reconstitute ActHIBTM were not formally presented to the Advisory Committee.

Indications: ActHIB vaccine is indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by H influenzae type b.

Key Regulatory Milestones:

05/24/2019 – FDA approval date

Package Insert