Rx only

For Intramuscular Injection Only

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use, Aluminum Phosphate Adsorbed (Td), is a sterile combination of tetanus toxoid (PUROGENATED®) and diphtheria toxoid for intramuscular use only. After shaking, the vaccine is a homogeneous white suspension.

The tetanus toxoid component is derived from Clostridium tetani , which is grown in a growth medium containing beef heart infusion according to the method of Mueller and Miller. 1 It is detoxified with formaldehyde. The toxoid is refined by the Pillemer alcohol fractionation method 2 and diluted with a solution containing sodium phosphate monobasic, sodium phosphate dibasic, glycine, and thimerosal (mercury derivative) as a preservative.

The diphtheria toxoid component is derived from Corynebacterium diphtheriae , which is grown in a growth medium containing an enzymatic digest of casein. The toxin is purified by ammonium sulfate precipitation and ion exchange chromatography. It is then detoxified with formaldehyde in the presence of L-lysine. The toxoid is maintained in sodium bicarbonate with L-lysine, formaldehyde, and thimerosal (mercury derivative) as a preservative.

The tetanus and diphtheria toxoids are each adsorbed to aluminum phosphate and brought to final volume with physiological saline. Thimerosal (mercury derivative) is added as a preservative to a final concentration of 1:10,000. The final product is formulated to contain 0.3 mg of aluminum per 0.5 mL dose from the aluminum phosphate adjuvant. The residual free formaldehyde content by assay is less than 0.02%.

Each 0.5 mL dose is formulated to contain 5 Lf units of tetanus toxoid and not more than 2 Lf units of diphtheria toxoid. The tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum in the guinea pig potency test.

Tetanus is an intoxication manifested primarily by neuromuscular dysfunction caused by a potent exotoxin elaborated by C. tetani . The incidence of tetanus in the United States has dropped dramatically with the routine use of tetanus toxoid with an average of 57 cases reported annually from 1985-1994. 3 During the period from 1995 through 1997, 124 cases of tetanus were reported from 33 states and the District of Columbia, resulting in an average annual incidence of 0.15 cases per 1,000,000 population. The case-fatality ratio varied from 2.3% for persons aged 20-39 years to 16% for persons ages 40-59 years and to 18% for persons aged >/=60 years. Previous immunization status was directly related to the severity of the disease, with the case-fatality ratio ranging from 6% for persons who had received 1 to 2 doses of tetanus toxoid to 15% for persons who were unvaccinated. Tetanus remains a severe disease, with adults >/=60 years at the highest risk of severe disease. 4

Spores of C. tetani are ubiquitous, and there is essentially no natural immunity to tetanus toxin. Thus, universal primary immunization with tetanus toxoid with subsequent maintenance of adequate antitoxin levels, by means of timed boosters, is recommended to protect all age groups. 5 Tetanus toxoid is a highly effective antigen and a completed primary series generally induces serum antitoxin levels of at least 0.01 antitoxin units/mL, a level that has been reported to be protective. 6 It is thought that protection persists for at least 10 years. 5

Diphtheria is a disease resulting from infection of the respiratory tract with Corynebacterium diphtheriae . This disease can be localized to the site of infection or can be associated with systemic toxicity, which may include myocarditis and neuritis and is caused by diphtheria toxin, an extracellular protein metabolite of toxigenic strains of C. diphtheriae . While the incidence of diphtheria in the US has decreased from over 200,000 cases reported in 1921, before the general use of diphtheria toxoid, to only 15 cases reported from 1990 to 1994, 3 the case fatality rate has remained constant at about 5% to 10%. The highest case-fatality rates are in the very young and in the elderly. Diphtheria remains a serious disease in some areas of the world as demonstrated by the recent epidemic in the former Soviet Union. 7

Following adequate immunization with diphtheria toxoid, which induces antitoxin, it is thought that protection lasts for at least 10 years. 5 Antitoxin levels of at least 0.01 antitoxin units/mL are generally regarded as protective. 8 This significantly reduces both the risk of developing diphtheria and the severity of clinical illness. It does not, however, eliminate carriage of C. diphtheriae in the pharynx or on the skin. 5

The toxoids of tetanus and diphtheria induce neutralizing antibodies to the toxins produced by the infecting organism. Serum antitoxin levels greater than 0.01 antitoxin units/mL are generally regarded as protective. 6,8 In a study of adults, aged 18 to 55 years, whose previous immunization status for diphtheria and tetanus was not known, such levels were achieved in 33/35 (94%) and 34/34 (100%) of subjects for diphtheria and tetanus, respectively, following a booster dose of Lederle-produced Tetanus and Diphtheria Toxoid Adsorbed For Adults Use. 9 In another clinical study, such levels were achieved in 29/30 (97%) and 29/29 (100%) of subjects for diphtheria and tetanus, respectively, in adults previously primed for diphtheria and tetanus after a single booster dose of Lederle-produced Tetanus and Diphtheria Toxoids Adsorbed For Adult Use. 10

Tetanus and Diphtheria Toxoids For Adult Use, Aluminum Phosphate Adsorbed, is indicated for active immunization against tetanus and diphtheria in adults and children 7 years of age and older. 5,11 (See DOSAGE AND ADMINISTRATION for "Tetanus Prophylaxis in Wound Management" and "Diphtheria Prophylaxis for Case Contacts.")

Tetanus and Diphtheria Toxoids Adsorbed For Adults Use is intended only for active immunization against tetanus and diphtheria, and is not to be used for treatment of actual infection.

The Advisory Committee on Immunization Practices (ACIP) recommends the use of the combined toxoids vaccine rather than single component vaccines for both primary and booster injections, including active tetanus immunization in wound management. 5

Persons recovering from tetanus or diphtheria.   Tetanus or diphtheria infection may not confer immunity; therefore, initiation or completion of active immunization is indicated at the time of recovery from these infections. 5

Neonatal tetanus prevention.   The risk to the fetus from tetanus/diphtheria toxoids in unknown. 12 The ACIP recommends that a previously unimmunized pregnant woman, who may deliver her child under nonhygienic circumstances and/or surroundings, should receive two properly spaced doses of Td before delivery, preferably during the last two trimesters. 5 Incompletely immunized pregnant women should complete the three-dose series. Those immunized more than 10 years previously should have a booster dose 5 (see PRECAUTIONS --Pregnancy ).

If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid, and other than a clean minor wound is sustained, only passive immunization should be given using Tetanus Immune Globulin (TIG). If passive immunization for diphtheria is needed, Diphtheria Antitoxin is recommended 5 (see DOSAGE AND ADMINISTRATION ).

As with any vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use may not protect 100% of individuals receiving the vaccine.

CONTRAINDICATIONS

HYPERSENSITIVITY TO ANY COMPONENT OF THE VACCINE, INCLUDING THIMEROSAL, A MERCURY DERIVATIVE, IS A CONTRAINDICATION.

THE OCCURRENCE OF ANY NEUROLOGICAL SYMPTOMS OR SIGNS OR AN ANAPHYLACTIC REACTION FOLLOWING ADMINISTRATION OF THIS PRODUCT IS A CONTRAINDICATION TO FURTHER USE.

THE DECISION TO ADMINISTER OR DELAY VACCINATION BECAUSE OF A CURRENT OR RECENT FEBRILE ILLNESS DEPENDS LARGELY ON THE SEVERITY OF THE SYMPTOMS AND THEIR ETIOLOGY. ALTHOUGH A MODERATE OR SEVERE FEBRILE ILLNESS IS SUFFICIENT REASON TO POSTPONE VACCINATION, MINOR ILLNESSES SUCH AS A MILD UPPER RESPIRATORY INFECTION WITH OR WITHOUT LOW GRADE FEVER ARE NOT CONTRAINDICATIONS. 5,13,14

ROUTINE IMMUNIZATION SHOULD BE DEFERRED DURING AN OUTBREAK OF POLIOMYELITIS, PROVIDING THE PATIENT HAS NOT SUSTAINED AN INJURY THAT INCREASES THE RISK OF TETANUS AND PROVIDING AN OUTBREAK OF DIPHTHERIA DOES NOT OCCUR SIMULTANEOUSLY. 15

THE CLINICAL JUDGMENT OF THE ATTENDING PHYSICIAN SHOULD PREVAIL AT ALL TIMES.

THIS PRODUCT IS NOT RECOMMENDED FOR IMMUNIZING PERSONS LESS THAN 7 YEARS OF AGE.

The concentration of diphtheria toxoid in preparations intended for use in persons 7 years of age or older is approximately 80% lower than that of the pediatric formulation (Diphtheria and Tetanus Toxoids Adsorbed, [DT]). The lower dosage of diphtheria toxoid is recommended for persons 7 years of age or older because adverse reactions to the diphtheria component are thought to be related to both dose and age. 5

IT IS RECOMMENDED THAT BOOSTER DOSES BE ADMINISTERED EVERY 10 YEARS, EXCEPT UNDER CIRCUMSTANCES OF WOUND MANAGEMENT (see DOSAGE AND ADMINISTRATION ). MORE FREQUENT ADMINISTRATION MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF REACTIONS. 5

Persons who experience Arthus-type hypersensitivity reactions or temperatures greater than 39.4°C (103°F), after a previous dose of tetanus toxoid usually have very high serum tetanus antitoxin levels and should not be given even emergency doses of Td more frequently than every 10 years, even if they have a wound that is neither clean nor minor. 13

If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid, and other than a clean, minor wound is sustained, only passive immunization should be given using TIG. 5 (See . )

Td should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer Td to individuals with coagulation disorders, it should be given with caution (see DRUG INTERACTIONS ).

Deaths have been reported in temporal association with the administration of preparations containing diphtheria and/or tetanus antigens (see ADVERSE REACTIONS ).

Health care professionals should administer this product with caution to patients with a possible history of latex sensitivity since this packaging contains dry natural rubber.

PRECAUTIONS

General

CARE IS TO BE TAKEN BY THE HEALTH CARE PROFESSIONAL FOR THE SAFE AND EFFECTIVE USE OF THIS PRODUCT.

  1. PRIOR TO ADMINISTRATION OF ANY DOSE OF Td, THE PARENT OR GUARDIAN OR ADULT PATIENT SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE PHYSICIAN SHOULD ASCERTAIN PREVIOUS IMMUNIZATION HISTORY, CURRENT HEALTH STATUS, AND OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE EVENT AFTER PREVIOUS IMMUNIZATIONS IN THE INDIVIDUAL TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH Td AND TO ALLOW AN ASSESSMENT OF BENEFITS AND RISKS.
  2. HEALTH CARE PROFESSIONALS SHOULD ADMINISTER THIS PRODUCT WITH CAUTION TO PATIENTS WITH A PRIOR HISTORY OF GUILLAIN-BARR[Eacute] SYNDROME (see ADVERSE REACTIONS ).
  3. BEFORE THE INJECTION OF ANY BIOLOGICAL, THE PHYSICIAN SHOULD TAKE ALL PRECAUTIONS KNOWN FOR PREVENTION OF ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient' history regarding possible sensitivity; the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
  4. Patients with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, or other causes, may have a reduced antibody response to active immunization procedures. 5,14,16,17 Deferral of administration of Td may be considered in individuals receiving immunosuppressive therapy. 5 Other groups should generally receive this vaccine according to the usual recommended schedule. 5,14,17,18 (see DRUG INTERACTIONS .)
  5. This product is not contraindicated for use in individuals with human immunodeficiency (HIV) virus infection. 16,19
  6. Since this product is a suspension containing an adjuvant, shake vigorously to obtain a uniform suspension in the vaccine container.
  7. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another. Needles should be disposed of properly and should not be recapped.
  8. Special care should be taken to prevent injection into or near a blood vessel or nerve.
  9. Health care professionals should administer this product with caution to patients with a possible history of latex sensitivity since this packaging contains dry natural rubber.

INFORMATION FOR PATIENTS

PRIOR TO THE ADMINISTRATION OF THIS VACCINE, HEALTH CARE PROFESSIONALS SHOULD INFORM THE PARENT, GUARDIAN, OR ADULT PATIENT OF THE RECOMMENDED IMMUNIZATION SCHEDULE FOR PROTECTION AGAINST TETANUS AND DIPHTHERIA AND THE BENEFITS AND RISKS OF VACCINATION AGAINST TETANUS AND DIPHTHERIA. GUIDANCE SHOULD BE PROVIDED ON MEASURES TO BE TAKEN SHOULD ADVERSE EVENTS OCCUR, SUCH AS ANTIPYRETIC MEASURES FOR ELEVATED TEMPERATURES AND THE NEED TO REPORT ADVERSE EVENTS TO THE HEALTH CARE PROFESSIONAL. PATIENTS, PARENTS, OR GUARDIANS SHOULD BE PROVIDED WITH VACCINE INFORMATION MATERIALS PRIOR TO THE TIME OF VACCINATION, AS MANDATED BY THE NATIONAL VACCINE INJURY COMPENSATION PROGRAM. 20

THE HEALTH CARE PROFESSIONAL SHOULD INFORM THE PARENT, GUARDIAN, OR ADULT PATIENT OF THE IMPORTANCE OF COMPLETING THE IMMUNIZATION SERIES UNLESS CONTRAINDICATED.

PATIENTS, PARENTS, OR GUARDIANS SHOULD BE INSTRUCTED TO REPORT ANY ADVERSE REACTIONS OR SUSPECTED ADVERSE EVENTS TO THEIR HEALTH CARE PROFESSIONAL (see ADVERSE REACTIONS , Adverse Event Reporting ).

Drug Interactions

Patients receiving immunosuppressive therapy (including irradiation, systemic corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may have a reduced response to active immunization procedures. 5,14,16,17 Although no specific studies are available, if immunosuppressive therapy will be discontinued shortly, it would be reasonable to defer immunization until the patient has been off therapy for one month; otherwise the patient should be vaccinated while still on therapy. 16

As with other intramuscular injections, tetanus and diphtheria toxoids should be given with caution to patients on anticoagulant therapy.

Tetanus Immune Globulin or Diphtheria Antitoxin, if used, should be given in a separate site with a separate needle and syringe.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use has not been evaluated for its carcinogenic or mutagenic potential or for impairment of fertility.

Pregnancy  

Pregnancy Category C.

Animal reproductive studies have not been conducted with this product. The risk to the fetus from tetanus/diphtheria toxoids is unknown. 12 The ACIP recommends that Td should be given to inadequately immunized pregnant women because it affords protection against neonatal tetanus. 19 Waiting until the second trimester is a reasonable precaution to minimize any theoretical teratogenic concern. 13 Maintenance of adequate immunization by routine boosters in non-pregnant women of childbearing age (see DOSAGE AND ADMINISTRATION ) can obviate the need to vaccinate women during pregnancy.

Nursing Mothers

Tetanus and diphtheria toxoids have not been isolated from breast milk. There is no evidence that breast milk from women receiving this product is harmful to infants. 19

Pediatric Use

The safety and effectiveness of Tetanus and Diphtheria Toxoids Adsorbed For Adult Use in children less than 7 years of age have not been established and this product is not recommended for this population.

For either primary or booster immunization against tetanus and diphtheria in children less than 7 years of age, the use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) is recommended. 5

Geriatric Use

The response to immunization with tetanus toxoid has been demonstrated to be slower, of lower magnitude, and decreased duration in geriatric patients. A group of 17 geriatric subjects (mean age 70.6 ± 4.0 years) exhibited significantly lower antibody titers for up to 12 months after an injection of tetanus toxoid as compared to a group of 20 young subjects (mean age 31.3 ± 6.5 years). 21,23 In another study, subjects ages 65 to 84 years who received 5 Lf of adsorbed tetanus toxoid showed a decreased IgG antibody production as compared to adults ages 25 to 34 years. 22 In these studies, adequate protection was achieved in geriatric patients. 23-25 In a study of 161 nursing home residents, mean age 77 years, minor pain and/or tenderness at the injection site was reported by 9% of the patients and no systemic reactions were reported. Because patients were not examined for reactions and 23 vaccinated patients had decreased awareness and poor communication skills, the actual incidence of reactions may be higher. 26 The ACIP recommends that persons age 50 and over receive a Td booster every 10 years as part of routine health maintenance. 27

ADVERSE REACTIONS

In an open-label study of Td in 35 adult subjects, aged 18-55 years, local reactions occurred in 28 (80%) of subjects. Injection site tenderness (80%) was the most common local reactions, followed by erythema and induration, each reported in 14% of subjects within 72 hours of injection of Td. There were reports of systemic reactions, including muscle pain (26%), headache (14%), and anorexia (6%) within 72 hours after immunization. 9

Local reactions, manifested by varying degrees of erythema, induration, and tenderness, are common after the administration of Td. 11,28-32 With vaccines in general, it is not uncommon for patients to note within 48 to 72 hours at or around the injection site the following minor reactions: edema, pain, or tenderness; redness; inflammation or skin discoloration; mass; or hypersensitivity reaction. Such local reactions are usually self-limited and require no therapy. As with other aluminum-containing vaccines, 28 a nodule may occasionally be palpable at the injection site for several weeks. Sterile abscess formation or subcutaneous atrophy at the injection site may also occur.

Systemic reactions such as fever, chills, myalgia, and headache also may occur. 10,29-32 Other adverse events which have been reported in temporal association with various tetanus toxoid-containing products include: warmth, swelling, cellulitis, malaise, weakness or fatigue, dizziness, irritablility, aches and pains, arthralgia, flushing, tachycardia, syncope, nausea, vomiting, lymphadenopathy, phlebitis, pruritis/itching, hives, sweating, acute midbrain syndrome, EEG disturbances, accommodation pareses, paresthesia, radiculopathy, brachial plexus neuropathy, cranial nerve pareses, myelopathy, myelitis, and cochlear lesions.

Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid in persons who have very high serum antitoxin antibodies due to overly frequent injections of tetanus toxoid (see ). 13

NEUROLOGICAL COMPLICATIONS, 33 SUCH AS CONVULSIONS, 34 ENCEPHALOPATHY, 34,35 AND VARIOUS MONO- AND POLYNEUROPATHIES, 35-41 INCLUDING GUILLAIN-BARR[Eacute] SYNDROME (GBS), 42,43 HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING TETANUS AND/OR DIPHTHERIA ANTIGENS. A REVIEW BY THE INSTITUTE OF MEDICINE (I.O.M.) FOUND A CAUSAL RELATION BETWEEN TETANUS TOXOID AND BRACHIAL NEURITIS AND GBS. 44

ALLERGIC AND HYPERSENSITIVITY REACTIONS, URTICARIA, ERYTHEMA MULTIFORME OR OTHER RASH 34 , AND, MORE RARELY, A SEVERE ANAPHYLACTIC REACTION 44 (IE, URTICARIA WITH SWELLING OF THE MOUTH, DIFFICULTY BREATHING, HYPOTENSION, SHOCK, OR DEATH) HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING TETANUS AND/OR DIPHTHERIA ANTIGENS.

DEATHS HAVE BEEN REPORTED IN TEMPORAL ASSOCIATION TO RECEIPT OF PREPARATIONS CONTAINING TETANUS AND DIPHTHERIA TOXOIDS. THE I.O.M. FOUND INADEQUATE EVIDENCE TO ACCEPT OR REJECT A CAUSAL RELATIONSHIP BETWEEN TETANUS TOXOID-CONTAINING PRODUCTS AND DEATH FROM CAUSES OTHER THAN ANAPHYLAXIS OR GBS. 44

A review of two large, active surveillance studies of adults and children who received approximately 0.7 to 1.2 million and 8.1 million doses of tetanus toxoid-containing vaccines, respectively, found that the number of cases of GBS after the administration of such vaccines was less than that expected by chance alone. 45

Adverse Event Reporting

Any adverse reactions following immunization should be reported by the health care professional to the US Department of Health and Human Services (DHHS). The National Vaccine Injury Compensation Program requires that the manufacturer and lot number of the vaccine administered be recorded by the health care professional in the vaccine recipient' permanent medical record (or in a permanent office log or file), along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine. The statute further requires the health care professional to report to the Secretary of the Department of Health and Human Services the occurrence following immunization of any event set forth in the Vaccine Injury Table, including anaphylaxis or anaphylactic shock within 4 hours, brachial neuritis within 2 to 28 days or any acute complication or sequelae (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time prescribed, or any event that would contraindicate further doses of vaccine, according to this Tetanus and Diphtheria Toxoids package insert. 20,46

The US Department of Health and Human Services has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. 20 The VAERS toll-free number for VAERS forms and information is 800-822-7967.

DOSAGE AND ADMINISTRATION

For Intramuscular Use Only  

The dose is 0.5 mL to be given intramuscularly.

Since this product is a suspension containing an adjuvant, shake vigorously to obtain a uniform suspension in the vaccine container. The vaccine should not be used if it cannot be resuspended.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see ). This product should not be used if particulate matter or discoloration are found.

The vaccine should be injected intramuscularly. The preferred site is the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or a blood vessel. Before injection, the skin at the injection site should be cleansed and prepared with a suitable germicide. After insertion of the needle, aspirate and wait to see if any blood appears in the syringe, which will help avoid inadvertent injection into a blood vessel. The needle length for adult vaccine administration should be of sufficient length to delivery the vaccine intramuscularly, in particular for intramuscular inejction into obese patients, a 1 inch or 1-1/2 inch needle may be necessary. Td is supplied in a multi-dose vial for use with syringe and needle; length of needle may be determined by the health care professional as needed for individual patients (see HOW SUPPLIED ). 11,19

PRIMARY IMMUNIZATION

The primary immunizing course for unimmunized individuals 7 years of age or older consists of two doses of 0.5 mL each, 4 to 8 weeks apart, followed by a third (reinforcing) dose of 0.5 mL 6 to 12 months after the second dose. The reinforcing dose is an integral part of the primary immunizing course. 5 Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved, nor does it necessitate starting the series over again, regardless of the length of time elapsed between doses. 5 In contrast, giving doses at less than recommended intervals may lessen the antibody response and therefore should be avoided.

Children who remain incompletely immunized at age 7 years and greater should be counted as having prior exposure to tetanus and diphtheria toxoids. For example, to complete the primary immunization series for tetanus and diphtheria, a child who previously received 2 doses of DTP or DTaP needs only 1 dose of Tetanus and Diphtheria Toxoids Adsorbed.

Any variation from the recommended volume or number of doses is discouraged. The serological response, clinical efficacy and/or frequency and severity of adverse reactions of schedules other than those described above have not been adequately studied. 19

Booster Doses

A booster dose of 0.5 mL of Td is given 10 years after completion of primary immunization and every 10 years thereafter. If a dose is given sooner than 10 years, as part of wound management or on exposure to diphtheria, the next booster is not needed for 10 years thereafter. MORE FREQUENT BOOSTER DOSES ARE NOT INDICATED AND MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF REACTIONS 5 (see ).

Diphtheria Prophylaxis for Case Contacts

All case contacts, household and others, who have previously received fewer than three doses of diphtheria toxoid, should receive an immediate dose of an appropriate diphtheria toxoid-containing preparation and should complete the series according to schedule. Case contacts who have previously received three or more doses, but who have not received a dose of a preparation containing diphtheria toxoid within the previous five years, should receive a booster dose of a diphtheria toxoid-containing preparation appropriate for their age. 5 Td is an appropriate preparation in these circumstances for persons 7 years of age or older.

Tetanus Prophylaxis in Wound Management

The need for active immunization with a tetanus toxoid-containing preparation, with or without passive immunization with Tetanus Immune Globulin (TIG) depends on both the condition of the wound and the patient' immunization history. Tetanus has rarely occurred among persons with a documented primary series of tetanus toxoid injections. 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 which are minor and uncontaminated, should receive a booster dose of a tetanus-toxoid preparation only if they have not received tetanus toxoid within the preceding 10 years. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding 5 years. Antitoxin antibodies develop rapidly in persons who have previously received at least two doses of tetanus toxoid. 5 If a booster dose is given sooner than 10 years as part of wound management, the next booster should not be given for 10 years thereafter.

Individuals who have not completed primary immunization against tetanus, or whose immunization history is unknown or uncertain, should be immunized with a tetanus toxoid-containing product. Completion of primary immunization thereafter should be ensured. In addition, if these individuals have sustained a tetanus-prone wound, the use of TIG is recommended. A separate syringe and site of administration should be used. 5

If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive immunization should be given using TIG. 5

SUMMARY GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT 5 *
History of
Tetanus
Toxoid (doses)
Clean, Minor
  Wounds   		All Other
  Wounds **   
Td TIG Td TIG
Unknown or <3
Yes No Yes Yes
>3 ***
No § No No o No
* Important details are in the text.
** Such as, but not limited to, wounds contaminated with dirt, feces, soil, saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite.
*** If only three doses of fluid toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.
§ Yes, if more than 10 years since last dose.
o Yes, if more than 5 years since last dose. (More frequent boosters are not needed and can accentuate side effects.)

Td is the preferred preparation for active tetanus immunization in wound management of patients 7 years of age or older. This is to enhance diphtheria protection, since a large proportion of adults are susceptible. Thus, by taking advantage of acute health care visits for wound management, some patients can be protected who otherwise would remain susceptible. 5

HOW SUPPLIED

NDC 0005-1875-31  5.0 mL vial

NDC 0005-1875-47  Single-Dose LEDERJECT® Disposable Syringes.

STORAGE

DO NOT FREEZE. STORE REFRIGERATED, AWAY FROM FREEZER COMPARTMENT, AT 2°C to 8°C (36°F to 46°F).

REFERENCES

  1. Mueller JH, Miller PA: Factors influencing the production of tetanal toxin. J Immunol 1947;56:143-147.
  2. Pillemer L, Grossberg DB, Wittler RG: The immunochemistry of toxins and toxoids. II. The preparation and immunological evaluation of purified tetanal toxoid. J Immunol 1946;54:213-224.
  3. CDC. Summary of notifiable diseases, United States, 1994. MMWR . 1995;43(53):70-71.
  4. Bardenheier, B et al: Tetanus surveillance--United States, 1995-1997. MMWR . 1998; 47(SS-2):1.
  5. 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).
  6. Federal Register Notice . Friday, December 13, 1985, Vol. 50, No. 240.
  7. Diphtheria Epidemic-New Independent States of the Former Soviet Union. 1990-1994. MMWR . 1995;44(10):177-181.
  8. Ipsen J. Immunization of adults against diphtheria and tetanus. NEJM . 1954;251:459-466.
  9. Unpublished data on file; Lederle Laboratories.
  10. Edwards KM, Decker MD, Graham BS, et al. Adult immunization with acellular pertussis vaccine. JAMA . 1993;269(1):53-56.
  11. ACP Task Force on Adult Immunization and Infectious Diseases Society of America: Guide for Adult Immunization , 3rd ed. Philadelphia, PA: American College of Physicians; 1994.
  12. Briggs GG, Freeman RK, Yaffee SJ. Drugs in Pregnancy and Lactation , 5th ed. Baltimore, MD: Williams and Wilkins; 1998.
  13. Update: Vaccine side effects, adverse reactions, contraindications, and precautions. MMWR . 1996;45 (RR-12):22-31.
  14. American Academy of Pediatrics. Report of the Committee of Infectious Diseases , 24th ed. Elk Grove Village, Ill; American Academy of Pediatric; 1997.
  15. Sutter RW, Patriarca PA, Suleiman AJM, et al. Attributable risk of DTP (Diphtheria and Tetanus Toxoids and Pertussis Vaccine) injection in provoking paralytic poliomyelitis during a large outbreak in Oman. J Infect Dis . 1992;165:444-449.
  16. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR . 1993;42(RR-4).
  17. Immunization of children infected with human immunodeficiency virus--supplementary ACIP statement. MMWR . 1988;37(12):181-183.
  18. Recommendation of the ACIP: Immunization of children infected with human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR . 1986;35(38):595-606.
  19. General Recommendations on Immunization--Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR . 1994;43(RR-1).
  20. 42 U.S.C. §§ 300 aa -25, -26. See also: CDC. Vaccine Adverse Event Reporting System--United States. MMWR . 1990:39:730-733.
  21. Burns, EA et al: Specific humoral immunity in the elderly: in vivo and in vitro response to vaccination. J Gerontology . 1993;48(6):B231-B236.
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