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.

See DOSAGE AND ADMINISTRATION for use in tetanus prophylaxis in wound management.

ADACEL vaccine is not indicated for the treatment of B pertussis, C diphtheriae or C tetani infections.

As with any vaccine, ADACEL vaccine may not protect 100% of vaccinated individuals.

ADACEL vaccine should be administered as a single injection of one dose (0.5 mL) by the intramuscular route.

SHAKE THE VIAL WELL to distribute the suspension uniformly before withdrawing the 0.5 mL dose for administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. (See DESCRIPTION.) If these conditions exist, the vaccine should not be administered.

When administering a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place.

The needle length should be sufficient to deliver the vaccine intramuscularly, but not so long as to involve underlying nerves and blood vessels or bone. The health-care professional should determine the appropriate size and length of the needle for each individual.

Aseptic technique must be used for withdrawal of each dose.

The preferred site is into the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there is a major nerve trunk.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. Do NOT administer this product intravenously or subcutaneously. Needles should not be recapped and should be disposed of properly.

Five years should have elapsed since the recipient†s last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine.

There are no data to support repeat administration of ADACEL vaccine.

The use of ADACEL vaccine as a primary series or to complete the primary series for tetanus, diphtheria, or pertussis has not been studied.

For individuals planning to travel to developing countries, a one-time booster dose of ADACEL vaccine may be considered if more than 5 years has lapsed since receipt of the previous dose of diphtheria toxoids, tetanus toxoids or pertussis-containing vaccine.

Diphtheria Prophylaxis for Case Contacts

The ACIP has published recommendations on vaccination for diphtheria prophylaxis in individuals who have had contact with a person with confirmed or suspected diphtheria. ⁽⁵⁾

Tetanus Prophylaxis in Wound Management

Clinicians should refer to guidelines for tetanus prophylaxis in routine wound management. ^(5)(14)

A thorough attempt must be made to determine whether a patient has completed primary immunization. Individuals who have completed primary immunization against tetanus and who sustain wounds that are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation if they have not received tetanus toxoid within the preceding 10 years. For tetanus prone wounds (eg., wounds contaminated with dirt, feces, soil and saliva, puncture wounds, avulsions and wounds resulting from missiles, crushing, burns or frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years. ⁽⁵⁾

ADACEL vaccine can be used as a one-time alternative to Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) vaccine in patients for whom the pertussis component is also indicated. (See INDICATIONS AND USAGE.)

If passive protection against tetanus is required, Tetanus Immune Globulin (Human) (TIG) may be administered at a separate site with a separate needle and syringe.

CONCOMITANT VACCINE ADMINISTRATION

Safety and immunogenicity data are available on concomitant administration of ADACEL vaccine with Hepatitis B (10 µg, two dose regimen) and trivalent inactivated influenza vaccines (TIV). (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections.)

Concurrent immunization of ADACEL vaccine with Hepatitis B vaccine did not result in reduced antibody responses to any of the antigens from either vaccine. ⁽¹²⁾

No interference in tetanus, diphtheria and influenza vaccine seroprotection rates and responses to detoxified PT, FIM or FHA were observed when ADACEL vaccine was administered concurrently with TIV compared to separate administration. A lower PRN GMC was observed when ADACEL vaccine was administered concurrently with TIV compared to separate administration. ⁽¹²⁾

The safety and effectiveness of co-administration of ADACEL vaccine with other vaccines have not been evaluated.

Separate injection sites and separate syringes must be used in case of concurrent administration.

STORAGE

Store between 2° - 8°C (35° - 46°F). DO NOT FREEZE. Discard product if exposed to freezing.

Do not use after expiration date.

The stopper of the vial for this product does not contain natural latex rubber.

Vial, 5 x 1 Dose - Product No. 49281-400-05
Vial, 10 x 1 Dose - Product No. 42981-400-10
CPT® Code: 90715
CPT is a registered trademark of the American Medical Association.

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, ed. 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. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children. Recommendations of the ACIP. MMWR 1997;46(RR-7):1-25.

5 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.

6 CDC. Pertussis - United States, 1997-2000. MMWR 2002;51(4):73-92.

7 CDC. Summary of notifiable diseases - United States, 2003. MMWR 2005;52(54):28,72.

8 Diphtheria toxoid. Tetanus toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W.B. Saunders 2004. p. 211-28, 745-81.

9 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.

10 CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

11 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.

12 Data on file at Aventis Pasteur Limited.

13 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.

14 CDC. Update on adult immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1991;40(RR-12):1-52.

15 CDC. Use of vaccines and immune globulins in persons with altered immunocompetence. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18.

16 CDC. Current trends - Vaccine Adverse Event Reporting System (VAERS) United States. MMWR 1990;39(41):730-3.

17 Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington: National Academy Press. 1994. p. 67-117.

18 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.

19 FDA. New reporting requirements for vaccine adverse events. FDA Drug Bull 1988;18(2):16-8.

Product Information as of 6/10/05.
Manufactured by:
Aventis Pasteur Limited
Toronto Ontario Canada
Distributed by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA