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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 combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT) and formaldehyde-treated filamentous hemagglutinin (FHA) and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide. INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is intended for intramuscular injection only.

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 are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The 3 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.

Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated PT, 25 mcg of FHA, and 8 mcg of pertactin.

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 (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.

Each 0.5-mL dose also contains 4.5 mg of NaCl, and aluminum adjuvant (not more than 0.625 mg aluminum by assay). Each dose also contains ≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate 80 (Tween 80). INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is formulated without preservatives.

The vaccine must be well shaken before administration to obtain a homogeneous, turbid, white suspension.

Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) is manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Marburg, Germany. The acellular pertussis antigens are manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Formulation, filling, testing, packaging, and release of the vaccine are performed by GlaxoSmithKline Biologicals.

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....

Read All Potential Side Effects and See Pictures of Infanrix »

Last reviewed on RxList: 3/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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