Proper Name
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Indication
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).
Description
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).
Key Regulatory Milestones
11/06/2019 - FDA approval date
Advisory Committee
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.
Package Insert
Advanced Facts