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

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, formalin, and thimerosal (mercury derivative) as a preservative.

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 containing sodium phosphate monobasic, sodium phosphate dibasic, glycine, and thimerosal (mercury derivative) as a preservative.

The diphtheria and tetanus 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 0.23 mg per 0.5 mL dose of aluminum 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 12.5 Lf units of diphtheria toxoid and 5 Lf units of tetanus toxoid. The diphtheria and tetanus components induce at least 2 neutralizing units/mL of serum in the guinea pig potency test.

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 . The incidence of diphtheria in the United States has decreased from over 200,000 cases reported in 1921, before the general use of diphtheria toxoid, to only four cases of diphtheria reported in 1997. Of these four cases, two persons, both with localized mild illness, had culture-confirmed diphtheria. ³ The case fatality rate has remained constant at about 5% to 10%. The highest case fatality rates are in the very young and the elderly. Diphtheria remains a serious disease in some areas of the world as demonstrated by the recent epidemic, during which over 7,000 cases of diphtheria were reported, in the former Soviet Union. ^3,4

Following adequate immunization with diphtheria toxoid, which induces antitoxin, it is thought that protection lasts for at least 10 years. ⁵ Serum antibody levels of at least 0.01 antitoxin units/mL are generally regarded as protective. ⁶ 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

Tetanus manifests systemic toxicity primarily by neuromuscular dysfunction caused by a potent exotoxin elaborated by C. tetani. The incidence of tetanus in the U.S. 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 aged 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. ⁷

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 antibody 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 antibody levels of at least 0.01 antitoxin units/mL, a level that has been reported to be protective. ⁸ It is thought that protection persists for at least 10 years. ⁵

The toxoids of tetanus and diphtheria induce neutralizing antibodies to the toxins produced by the infecting organisms. Serum antibody levels greater than 0.01 antitoxin units/mL are generally regarded as protective. ^6,8 In one clinical study in Jamaica, West Indies, children ranging in age from three months to six years received two doses administered 28 days apart of DT in a primary series. Subjects 6 months of age or less were included if they had not received a previous dose of diphtheria or tetanus toxoids as determined through the immunization history provided by the mother and clinic records, and subjects over 6 months of age were included if they had a pre-immunization titer of less than 0.01 IU/mL. Protective levels of greater than 0.01 IU/mL were achieved in 22/23 (96%) of the children for diphtheria as measured by the rabbit skin method, and 26/26 (100%) of the children for tetanus as titrated in the mouse lethal method. The mean age of immunization was 21 months of age in the diphtheria subjects and 26 months in the tetanus subjects. ⁹

Diphtheria and Tetanus Toxoids Adsorbed, Aluminum Phosphate Adsorbed, for pediatric use is indicated for active immunization against diphtheria and tetanus diseases in infants and children from 2 months of age up to 7 years of age (prior to their seventh birthday) for whom the use of a combined vaccine containing pertussis antigen is contraindicated. ^5,10 (See DOSAGE AND ADMINISTRATION for "Tetanus Prophylaxis in Wound Management" and "Diphtheria Prophylaxis for Case Contacts.")

Protection against diphtheria and tetanus is based on a full course of immunization.

DT is intended only for active immunization against diphtheria and tetanus and is not to be used for treatment of actual infection or in people 7 years of age or older.

Persons recovering from tetanus or diphtheria. Diphtheria or tetanus infection may not confer immunity; therefore, initiation or completion of active immunization is indicated at the time of recovery from these infections. 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 human tetanus immune globulin (TIG). If passive immunization for diphtheria is needed, equine diphtheria antitoxin is recommended. ⁵ (see DOSAGE AND ADMINISTRATION )

As with any vaccine, DT 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 ALLERGIC OR ANAPHYLACTIC REACTION WHICH HAS FOLLOWED THE 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 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. ^5,10,11

ROUTINE IMMUNIZATION SHOULD BE DEFERRED DURING AN OUTBREAK OF POLIOMYELITIS, PROVIDED THE PATIENT HAS NOT SUSTAINED AN INJURY THAT INCREASES THE RISK OF TETANUS AND PROVIDED AN OUTBREAK OF DIPHTHERIA DISEASE DOES NOT OCCUR SIMULTANEOUSLY. ¹²

THE CLINICAL JUDGMENT OF THE ATTENDING HEALTH CARE PROFESSIONAL SHOULD PREVAIL AT ALL TIMES.

THIS PRODUCT IS NOT RECOMMENDED FOR IMMUNIZING PERSONS ON OR AFTER THEIR SEVENTH BIRTHDAY.

For individuals 7 years of age or older, Tetanus and Diphtheria Toxoids Adsorbed, for adult use (Td), should be used instead of DT. 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. 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

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 antibody levels and should not be given even emergency doses of a tetanus toxoid-containing preparation more frequently than every 10 years, even if they have a wound that is neither clean nor minor. ¹¹

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 human TIG ⁵ (see ).

DT should not be given to infants or children 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 DT to children 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 prescribe and/or 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 DT, THE PARENT OR GUARDIAN SHOULD BE ASKED ABOUT THE PERSONAL HISTORY, FAMILY HISTORY, AND RECENT HEALTH STATUS OF THE VACCINE RECIPIENT. THE HEALTH CARE PROFESSIONAL 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 CHILD TO BE IMMUNIZED, IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH DT 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 HEALTH CARE PROFESSIONAL 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. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, systemic corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, generalized malignancy, or other causes, may have a reduced antibody response to active immunization procedures. ^5,10,13,14 Deferral of administration of DT may be considered in individuals receiving immunosuppressive therapy if it will be discontinued shortly. ⁵ Other groups should generally receive this vaccine according to the usual recommended schedule ^5,10,14,15 (see DRUG INTERACTIONS ).
5. This product is not contraindicated for use in individuals with HIV virus infection. ^13,15
6. Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use 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 replaced.
8. Special care should be taken to prevent injection into or near a blood vessel or nerve.
9. Health care professionals should prescribe and/or administer this product with caution to patients with a possible history of latex sensitivity since this packaging contains dry natural rubber.

Information for Parents or Guardians  

PRIOR TO THE ADMINISTRATION OF THIS VACCINE, HEALTH CARE PROFESSIONALS SHOULD INFORM THE PARENT OR GUARDIAN OF THE RECOMMENDED IMMUNIZATION SCHEDULE FOR PROTECTION AGAINST TETANUS AND DIPHTHERIA DISEASES AND THE BENEFITS AND RISKS OF VACCINATION AGAINST TETANUS AND DIPHTHERIA DISEASES. GUIDANCE SHOULD BE PROVIDED ON MEASURES TO BE TAKEN BY THE PARENT OR GUARDIAN SHOULD SUSPECTED ADVERSE EVENTS OCCUR, SUCH AS ANTIPYRETIC MEASURES FOR ELEVATED TEMPERATURES AND THE NEED TO REPORT ANY SUSPECTED ADVERSE OCCURRENCES TO THE HEALTH CARE PROFESSIONAL. PARENTS OR GUARDIANS SHOULD BE PROVIDED WITH VACCINE INFORMATION STATEMENTS PRIOR TO THE TIME OF VACCINATION, AS REQUIRED BY THE NATIONAL CHILDHOOD VACCINE INJURY ACT ¹⁷ (see Adverse Event Reporting ).

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

Drug Interactions

Infants or children receiving immunosuppressive therapy (including irradiation, systemic corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may have a reduced response to active immunization procedures. ^5,10,13,14 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. ¹³ Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids is thought not to be immunosuppressive ¹³ (see PRECAUTIONS , General ).

As with other intramuscular injections, diphtheria and tetanus toxoids should be given with caution to children on anticoagulant therapy (see ).

Human TIG or equine diphtheria antitoxin, if used, should be given in a separate site with a separate needle and syringe.

See DOSAGE AND ADMINISTRATION for information regarding simultaneous administration with other vaccines.

Carcinogensis, Mutagenesis, Impairment of Fertility

DT for pediatric use, has not been evaluated for its carcinogenic or mutagenic potential or for impairment of fertility.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with DT vaccine. It is not known whether DT vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. DT is not recommended for use in a pregnant woman. THIS PRODUCT IS NOT RECOMMENDED FOR USE IN INDIVIDUALS 7 YEARS OF AGE OR OLDER.

Nursing Mothers

THIS PRODUCT IS NOT RECOMMENDED FOR USE IN INDIVIDUALS 7 YEARS OF AGE OR OLDER.

Pediatric Use

The safety and effectiveness of DT for pediatric use, in children below the age of 6 weeks have not been established (see DOSAGE AND ADMINISTRATION ).

For either primary or booster immunization against tetanus and diphtheria diseases of individuals 7 years of age and older, the use of Tetanus and Diphtheria Toxoids Adsorbed, for adult use (Td) is recommended. ^5,10

This combined preparation for protection against both diphtheria and tetanus diseases is designed particularly to meet the needs of children less than 7 years of age for whom the use of a combined vaccine containing pertussis antigen is contraindicated. A combined antigen containing pertussis vaccine is the preferred vaccine for primary immunization.

Geriatric Use

This vaccine is NOT recommended for use in adult populations.

ADVERSE REACTIONS

In a prospective study that compared the reaction rates of a similar diphtheria and tetanus toxoid-containing vaccine to diphtheria and tetanus toxoids and pertussis vaccine (DTP), 784 children 0 to 6 years of age who were scheduled to receive routine DTP immunization instead received a dose of diphtheria and tetanus toxoid vaccine. Of these children, 684 and 110 were enrolled in the open-label and double-blind portions of the study, respectively. Most (98.8%) of the of the children received diphtheria and tetanus toxoid vaccine as a first, second, or third dose of the primary immunization series; the remainder of the immunizations were administered as a booster (4 ^th or 5 ^th ) dose. Local and systemic reactions that occurred within 48 hours of immunization were reported by parents through home visit, telephone call or mail-in questionnaire. Local reactions occurring within 48 hours following immunization for both the blinded and unblinded groups included redness (7.6%), swelling (7.6%), and pain (9.9%). Systemic symptoms included drowsiness (14.9%), fretfulness (22.6%), vomiting (2.6%), anorexia (7.0%), and persistent crying (0.7%). The incidence rates of fever >/=38°C (100.4°F) and >/=39°C (102.2°F), reported in a subset of children (n=292) three to six hours post-immunization, were 9.3% and 0.7% respectively. ^18,19

Local reactions, manifested by varying degree of erythema, induration, and tenderness, may occur after administration of DT. ^18,19 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 induration; or local hypersensitivity. Such local reactions are usually self-limited and require no therapy. As with other aluminum-containing vaccines, ²⁰ 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.

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 ²⁰ (see ).

Pallor, coldness, and hyporesponsiveness have been reported in a child receiving a DT vaccine. ¹⁹

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, irritability, 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.

NEUROLOGICAL COMPLICATIONS, ²¹ SUCH AS CONVULSIONS, ²² ENCEPHALOPATHY, ^22,23 AND VARIOUS MONO- AND POLYNEUROPATHIES, ^23-29 INCLUDING GUILLAIN-BARR[Eacute] SYNDROME (GBS), ^30-31 HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING DIPHTHERIA AND/OR TETANUS ANTIGENS. A REVIEW BY THE INSTITUTE OF MEDICINE (I.O.M.) FOUND EVIDENCE OF A CAUSAL RELATION BETWEEN TETANUS TOXOID AND BRACHIAL NEURITIS AND GBS, BUT DID NOT FIND EVIDENCE OF A CAUSAL RELATION BETWEEN DT AND SUDDEN INFANT DEATH SYNDROME (SIDS). ³² ALLERGIC AND HYPERSENSITIVITY REACTIONS, URTICARIA, ERYTHEMA MULTIFORME OR OTHER RASH, ARTHRALGIAS ²² AND, MORE RARELY, A SEVERE ANAPHYLACTIC REACTION ³² (I.E., URTICARIA WITH SWELLING OF THE MOUTH, DIFFICULTY BREATHING, HYPOTENSION, SHOCK, OR DEATH) HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING DIPHTHERIA AND/OR TETANUS 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. ³²

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. ³³

Adverse Event Reporting

Any suspected adverse events following immunization should be reported by the health care professioinal to the US Department of Health and Human Services (DHHS). The National Childhood Vaccine Injury Act 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 the 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 US DHHS the occurrence following immunization of any events set forth in the statute's Vaccine Injury Table, including anaphylaxis or anaphylactic shock within 7 days, brachial neuritis within 28 days or any acute complication or sequela (including death) of the above events or any events that would contraindicate further doses of vaccine, according to this Diphtheria and Tetanus Toxoids, Aluminum Phosphate Adsorbed, for pediatric use, package insert. ¹⁷

The US DHHS 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. ¹⁷ 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 immediately prior to use 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 (see ). This product should not be used if particulate matter or discoloration is found.

The vaccine should be injected intramuscularly. The preferred sites are the anterolateral aspect of the thigh or 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 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. If blood appears, withdraw the needle and prepare for a new injection at another site.

This combined preparation for protection against both diphtheria and tetanus diseases is designed particularly to meet the need of children between 2 months and less than 7 years of age for whom the use of a combined vaccine containing pertussis antigen is contraindicated.

It is recommended that active immunization against diphtheria and tetanus be started at 2 months of age.

No data are available for DT given simultaneously with OPV (or IPV), MMR, Hepatitis B, Hib, and rotavirus vaccines. Nonetheless, the ACIP encourages simultaneous administratioan of routine childhood vaccines for children who are at the recommended age for these vaccines and for whom no specific contraindications exist at the time of immunization. ^16,34

Unimmunized infants and children less than 1 year of age for whom vaccine containing pertussis antigen is contraindicated should receive three doses of 0.5 mL each of DT at 4- to preferably 8-week intervals, followed by a fourth (reinforcing) dose of 0.5 mL, 6 to 12 months after the third dose, for the primary series. ^5,10

Unimmunized children from 1 up to 7 years of age (prior to the 7 ^th birthday) for whom vaccine containing pertussis antigen is contraindicated should receive two doses of 0.5 mL each of DT, at 4- to preferably 8-weeks intervals, followed by a third (reinforcing) dose 6 to 12 months later, for the primary series. ^5,10

If after beginning a DTP series, further doses of vaccine containing pertussis antigen become contraindicated, DT should be substituted for each of the remaining doses. ^5,10

The reinforcing dose is an integral part of the primary immunizing series.

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. ^5,10

A booster dose of 0.5 mL is indicated at age 4 to 6 years (prior to the 7 ^th birthday), preferably prior to entrance into kindergarten or elementary school. However, if the last dose of the primary immunizing series was administered after the fourth birthday, a booster prior to school entry is not considered necessary. ^5,10

For either primary or booster immunization against tetanus and diphtheria of individuals 7 years of age and older, the use of Tetanus and Diphtheria Toxoids Adsorbed, for adult use, is recommended. ^5,10

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 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 dose of a diphtheria toxoid-containing preparation appropriate for their age. ⁵ This combined preparation against both diphtheria and tetanus is designed particularly to meet the need of children less than 7 years of age for whom the use of a combined vaccine containing pertussis antigen is contraindicated.

Tetanus Prophylaxis in Wound Management

The need for diphtheria and tetanus toxoids (active immunization), with or without human TIG (passive immunization) depends upon 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. ⁵

For routine wound management of children under 7 years of age who are not completely immunized, DT should be used instead of single-antigen tetanus toxoid (if pertussis antigen is contraindicated or individual circumstances are such that potential febrile reactions following DTP might confound the management of the patient). ⁵ Completion of primary vaccination thereafter should be ensured.

If emergency tetanus prophylaxis is indicated during the period between the last primary dose and the reinforcing dose, a 0.5 mL dose of DT should be given. If given before six months have elapsed, it should be counted as a primary dose; if given after six months, it should be regarded as the reinforcing dose.

For tetanus-prone wounds in children who have had fewer than three, or an unknown number of immunizations with a tetanus toxoid-containing product, passive immunization with human TIG is also recommended. ⁵ A separate syringe and site of injection should be used.

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 human TIG. ⁵

HOW SUPPLIED

NDC 0005-1858-31  5.0 mL vial

STORAGE

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

REFERENCES

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3. CDC. Summary of Notifiable Diseases, United States, 1997. MMWR . 1998; 46(54): viii.
4. Diphtheria, Epidemic--New Independent States of the Former Soviet Union, 1990-1999 MMWR . 1995:44(10):177-181.
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(10).
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9. Unpublished data on file; Lederle Laboratories.
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17. 42 U.S.C. §§ 300 aa -25,-26. See also: CDC. Vaccine Adverse Event Reporting System--United States. MMWR . 1190;39:730-733.
18. Cody C, Baroff LJ, Cherry JD, et al. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatrics . 1981;68:650-660.
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21. Rutledge SL, Snead OC. Neurologic complications of immunizations. J Pediatr 1986;109:917-924.
22. CDC. Adverse Events Following Immunization. MMWR. 1985;34(3):43-47.
23. Schlenska GK. Unusual neurological complications following tetanus toxoid administration. J Neurol . 1977;215:299-302.
24. Blumstein GI, Kreithen H. Peripheral neuropathy following tetanus toxoid administration. JAMA . 1966;198:1030-1031.
25. Reinstein L, Pargament JM, Goodman JS. Peripheral neuropathy after multiple tetanus toxoid injections. Arch Phys Med Rehabil . 1982;63:332-334.
26. Tsairis P, Duck PJ, Mulder DW. Natural history of brachial plexus neuropathy. Arch Neurol . 1972;27:109-117.
27. Quast U, Hennessen W, Widmark RM. Mono- and polyneuritis after tetanus vaccination. Devel Bio Stand . 1979;43:25-32.
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Manufactured by:

LEDERLE LABORATORIES

Division American Cyanamid Company

Pearl River, NY 10965 USA

U.S. Gov't. License No. 17

Marketed by:

WYETH-LEDERLE VACCINES AND PEDIATRICS

Wyeth-Ayerst Laboratories

Philadelphia, PA 19101 USA

C1 6105-1  Issued February 10, 2000