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.
05/24/2019 - FDA approval date
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.