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Uses
DECAVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older.
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Other Information
DECAVAC vaccine, Tetanus and Diphtheria Toxoids Adsorbed, for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.
Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. (5) Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.
Each 0.5 mL dose of DECAVAC vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, (≤0.3 mcg mercury/dose) not as a preservative] from the manufacturing process, aluminum potassium sulfate adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 mcg (0.02%) of residual formaldehyde.
The tip caps of the prefilled syringes may contain natural rubber latex. No other components of any presentation contain latex.
Sources
Decavac Manufacturers
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Sanofi Pasteur Inc.
Decavac | Sanofi Pasteur Inc.
2.1. Dosage and SchedulePrimary Immunization
DECAVAC vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria or who have begun a primary immunization series but did not complete it. The primary immunization series consists of three 0.5 mL doses. The first two doses are administered at least 4 weeks apart and the third dose is administered at least 6 months after the second dose.
DECAVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria in persons 7 years of age or older who have received one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT). However, the safety and efficacy of DECAVAC vaccine in such regimens have not been evaluated.
Routine Booster Immunization
DECAVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter. (1)
Tetanus Prophylaxis in Wound Management
For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection. (2) DECAVAC vaccine is approved for wound management of patients 7 years of age and older.
The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).
When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given. (2)
Table 1: Guide to Use of Tetanus and Diphtheria Toxoids Adsorbed (Td) and Tetanus Immune Globulin (TIG) (Human) for Tetanus Prophylaxis in Routine Wound Management for Persons 7 Years of Age and Older History of Adsorbed Tetanus Toxoid (doses) Clean, Minor Wounds All Other Wounds* Td TIG Td TIG * Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite. † If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably, an adsorbed toxoid should be given. ‡ Yes, if ≥10 years since the last tetanus toxoid-containing vaccine dose. § Yes, if ≥5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.) Unknown or <three Yes No Yes Yes ≥three† No‡ No No§ NoDiphtheria Prophylaxis for Case Contacts
DECAVAC vaccine may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis. (2)
2.2. AdministrationParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, DECAVAC vaccine should not be administered.
DECAVAC vaccine, after shaking, is a turbid liquid, whitish-gray in color.
For DECAVAC vaccine supplied in vials, shake the vial well before withdrawing the dose. Discard vial if DECAVAC vaccine cannot be resuspended.
For DECAVAC vaccine supplied in syringes, shake the syringe well before administering the dose. Discard syringe if DECAVAC vaccine cannot be resuspended.
Inject 0.5 mL intramuscularly. The preferred site is the deltoid muscle. DECAVAC vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer DECAVAC vaccine intravenously or subcutaneously.
DECAVAC vaccine should not be combined through reconstitution or mixed with any other vaccine.
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