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Components of
Tdap VaccineExcipients Table
Allergens Table
Components Table
Indication
For active booster immunization for the prevention of tetanus, diphtheria and pertussis
For active immunization against diphtheria, tetanus, and pertussis
Proprietary Name
Manufacturer
Viability
Inactivated
Microorganism
Bordetella pertussis
Corynebacterium diphtheriae
Clostridium tetani
Bordetella pertussis
Corynebacterium diphtheriae
Clostridium tetani
Approved Ages 11-64 years 10 years and older Dose
0.5 mL
0.5 mL
Route
Intramuscular
Intramuscular
Appearance
White, homogenous, cloudy liquid after shaking
Homogeneous, turbid white after shaking
Concentration (per 0.5 mL)
Acellular Pertussis
Detoxified Pertussis Toxin, 2.5 mcg
Filamentous Hemagglutinin, 5 mcg
Pertactin, 3 mcg
Fimbriae Types 2 and 3, 5 mcgTetanus Toxoid, 5 Lf
Diphtheria Toxoid, 2 Lf
Diphtheria Toxoid, 2.5 Lf
Tetanus Toxoid, 5 Lf
Pertactin, 2.5 mcg
FHA, 8 mcg
PT (inactivated), 8 mcg
Excipients
Aluminum phosphate, 1.5 mg
Formaldehyde, ≤ 5 mcg
Glutaraldehyde, <50 ng
2-phenoxyethanol, 3.3 mg (not as a preservative)
Formaldehyde, ≤100 mcg
Polysorbate 80 (Tween 80), ≤100 mcg
Adjuvants/dose
Aluminum phosphate, 1.5 mg
Sodium Chloride, 4.5 mg
Aluminum Adjuvant, ≤ 0.39 mg
Allergens
Tip caps of prefilled syringes may contain natural rubber latex
Tip cap and rubber plunger of needleless prefilled syringes contain dry natural latex rubber
Preservatives
None
None
Media
Bordetella pertussis
Stainer-Scholte
Stainer-Scholte liquid
Corynebacterium diphtheria
Mueller's
Fenton medium containing a bovine extract
Clostridium tetani
Mueller-Miller casamino acide
Lantham medium derived from bovine casein
Packaging
Vials, single dose
Syringe, single dose
Vials, single dose
Prefilled syringes, single dose
Routine Storage
2 to 8° C (35-46° F)
Do not freeze
2 to 8° C (35-46° F)
Do not freeze
Package Insert updated December 2010 November 2011 updated July 2011
This page was last updated on January 23, 2012
© 2012 Institute for Vaccine Safety
