Adacel TDAP

Name: Adacel TDAP

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Adacel®

Tdap

Rx only

Adacel TDAP - Clinical Pharmacology

Background

Tetanus

Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C tetani. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal muscles. The muscle spasms usually involve the jaw (lockjaw) and neck and then become generalized.

Spores of C tetani are ubiquitous. Serological tests indicate that naturally acquired immunity to tetanus toxin does not occur in the US. Thus, universal primary immunization, with subsequent maintenance of adequate antitoxin levels by means of appropriately timed boosters, is necessary to protect all age groups. Following immunization, protection generally persists for at least 10 years. (4)

Diphtheria

C diphtheriae may cause both localized and generalized disease. The systemic intoxication is caused by diphtheria exotoxin, an extracellular protein metabolite of toxigenic strains of C diphtheriae. Both toxigenic and nontoxigenic strains of C diphtheriae can cause disease, but only strains that produce toxin can cause severe manifestations such as myocarditis and neuritis. Toxigenic strains are more often associated with severe or fatal respiratory infections than with cutaneous infections.

Complete immunization significantly reduces the risk of developing diphtheria and immunized persons who develop disease have milder illness.

Immunization with diphtheria toxoid does not, however, eliminate carriage of C diphtheriae in the pharynx, nose, or on the skin. Following immunization, protection lasts at least 10 years. (4)

Pertussis

Pertussis (whooping cough) is a disease of the respiratory tract, most often caused by B pertussis. This gram-negative coccobacillus produces a variety of biologically active components, though their role in pathogenesis is not clearly defined.

Mechanism of Action

Protection against disease attributable to C tetani is due to the development of neutralizing antiboides to tetanus toxin. A serum antitoxin level of ≥0.1 IU/mL is considered protective, although a level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (5) Protection against disease attributable to C diphtheriae is due to the development of neutralizing antibodies to diphtheria toxin. A serum antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (6) Levels of 1.0 IU/mL have been associated with long-term protection. (7)

The mechanism of protection from B pertussis disease is not well understood. However, the pertussis components in Adacel vaccine (i.e., detoxified PT, FHA, PRN and FIM) have been shown to prevent pertussis in infants in a clinical trial with DAPTACEL vaccine. (See Clinical Studies.)

Indications and Usage for Adacel TDAP

Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.

The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied.

Vaccination with Adacel vaccine may not protect all of vaccinated individuals.

Storage

Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used.

Do not use after expiration date shown on the label.

References

1 Stainer DW, et al. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20. 2 Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11. 3 Mueller JH, et al. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7. 4 CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28. 5 CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48. 6 FDA. Department of Health and Human Services (DHHS). Biological products bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Fed Reg 1985;50(240):51002-117. 7 Diphtheria toxoid. Tetanus toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: WB Saunders; 2004. p. 211-28, 745-81. 8 Gustafsson L, et al. A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine. N Engl J Med 1996;334(6):349-55. 9 Data on file at Sanofi Pasteur Limited. 10 CDC. Preventing tetanus, diphtheria and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. MMWR 2006;55(RR-17):1-36. 11 CDC. Preventing tetanus, diphtheria and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. MMWR 2006;55(RR-3):1-35. 12 CDC. Update: vaccine side effects, adverse reactions, contraindications and precautions. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35. 13 CDC. Update on adult immunization. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-12):1-52. 14 Stratton KR, et al, editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington: National Academy Press; 1994. p. 67-117. 15 CDC. Current trends - Vaccine Adverse Event Reporting System (VAERS) United States. MMWR 1990;39(41):730-3. 16 CDC. Current trends - national vaccine injury act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200. 17 FDA. New reporting requirements for vaccine adverse events. FDA Drug Bull 1988;18(2):16-8.

Product Information as of January 2009.

Printed in USA.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

R5-0109 USA
5751

PRINCIPAL DISPLAY PANEL - Syringe Container

NDC 49281-400-15
Tdap

Tetanus Toxoid, Reduced
Diphtheria Toxoid
and Acellular
Pertussis Vaccine
Adsorbed

5 Prefilled
Syringes
0.5 mL each

Rx only

Adacel®
For adolescent
and adult use.

sanofi pasteur

ADACEL  TDAP
clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-400
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI) CLOSTRIDIUM TETANI 5   in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE) CORYNEBACTERIUM DIPHTHERIAE 2   in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS) BORDETELLA PERTUSSIS 2.5 ug  in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS) BORDETELLA PERTUSSIS 5 ug  in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS) BORDETELLA PERTUSSIS 3 ug  in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS) BORDETELLA PERTUSSIS 5 ug  in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg  in 0.5 mL
FORMALDEHYDE 5 ug  in 0.5 mL
GLUTARAL 50 ng  in 0.5 mL
PHENOXYETHANOL 3.3 mg  in 0.5 mL
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:49281-400-10 10 VIAL (VIAL) in 1 PACKAGE
1 0.5 mL in 1 VIAL
2 NDC:49281-400-05 5 VIAL (VIAL) in 1 PACKAGE
2 0.5 mL in 1 VIAL
3 NDC:49281-400-15 5 SYRINGE (SYRINGE) in 1 PACKAGE
3 0.5 mL in 1 SYRINGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125111 06/10/2005
Labeler - Sanofi Pasteur Limited (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE
Revised: 06/2009   Sanofi Pasteur Limited
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