INFANRIX
INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), and 8 mcg of pertactin (69 kiloDalton outer membrane protein).
Advisory Board:
Data regarding the safety and efficacy of Infanrix were presented and discussed at “the July 10, 1996 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee meeting.
Indications: For active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the 7th birthday).
Key Regulatory Milestones:
11/06/2019 – FDA approval date