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(Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
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).
The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor present an undue risk for bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.
The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.
Diphtheria and tetanus toxoids and pertussis antigens (PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide.
Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.625 mg aluminum by assay) and 4.5 mg of sodium chloride. Each dose also contains ≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate 80 (Tween 80).
INFANRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.
INFANRIX is formulated without preservatives.
What are the possible side effects of diphtheria, tetanus, acellular pertussis vaccine (Daptacel (DTaP), Infanrix (DTaP), Infanrix (DTaP) Preservative Free, Tripedia (DTaP))?
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the child's doctor if the previous shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your child's health than receiving this vaccine....
Last reviewed on RxList: 11/13/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Infanrix Information
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