Significant revisions since the last chapter update are highlighted in the CIG Table of Updates, which is available on the PHAC website.
For additional information, refer to previously published National Advisory Committee on Immunization (NACI) Statements and Statement Updates.
Tetanus (lockjaw) is caused by a neurotoxin produced by the bacterium Clostridium tetani.
C. tetani spores are widely distributed in soil worldwide and have also been detected in the intestines of animals and humans.
C. tetani spores are usually introduced into the body through a wound that is contaminated with soil, animal/human feces or dust. C. tetani spores will germinate into bacilli in an anaerobic environment, such as necrotic tissue. The bacilli release a potent neurotoxin. The incubation period is generally 3 to 21 days (range, 1 day to several months). Since tetanus is caused by the neurotoxin, it is not transmitted person-to-person.
Cases of tetanus related to lacerations (most frequent), injection drug use, and animal bites have been reported, as well as rare cases occurring after bowel surgery or aspiration of soil and feces. Cases may occur following small, insignificant wounds, especially when there is necrotic tissue present. It is often associated with blunt trauma or deep puncture wounds. Tetanus rarely occurs in fully vaccinated people and, if it does, it is usually mild.
Spectrum of clinical illness
Tetanus is characterized by muscle spasms, usually in a descending pattern, beginning in the jaw muscles. As the disease progresses, prolonged frequent spasms may occur, contributing to serious complications and death, unless treatment is provided. Globally, tetanus is common in neonates who are delivered without adequate sterile procedures. The case fatality rate in the unvaccinated varies from 10% to over 80%, and is highest in infants and the elderly.
Tetanus occurs worldwide but occurs most frequently in agricultural regions and densely populated regions. A total of 9,683 cases of tetanus were reported to the World Health Organization (WHO) in 2010. Tetanus is relatively uncommon in most developed countries because of long-standing immunisation programmes. Although neonatal tetanus has been eliminated in North America, it remains an important global issue.
Tetanus is rare in Canada (refer to Figure 1). Between 1990 and 2010, the number of cases reported annually ranged from 1 to 10, with an average of 4 per year. During this period, persons 60 years of age and older accounted for 48% of the cases, of which 59% were males. No cases were reported among neonates. The immunization status of the reported cases was not known. Only eight deaths due to tetanus have been reported since 1990; the last two were reported in 2009. There is limited evidence on the protective concentrations of tetanus antitoxin in the Canadian population. A serosurvey of adult blood donors in Toronto found that 17.5% of donors did not have protective levels of tetanus antitoxin. Factors associated with lack of immunity to tetanus include increasing age, birth outside Canada, and absence of immunization records.
Tetanus toxoid is only available in combination vaccines.
For complete prescribing information, consult the product leaflet or information contained within Health Canada’s authorized product monographs available through the Drug Product Database. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for lists of all vaccines and passive immunizing agents available for use in Canada and their contents.
Protective antitoxin concentrations occur in virtually all healthy infants and children who receive primary tetanus immunization. Efficacy in standard pre-exposure and post-wound booster immunization regimens in adults has not been assessed in randomized trials but has been demonstrated in observational studies. Cases of tetanus occurring in fully immunized persons whose last dose was within the last 10 years are extremely rare.
It has been consistently demonstrated in clinical trials that one month after completion of a three dose primary series at least 99% of vaccinees have protective antibody titre.
Tetanus toxoid-containing vaccine is recommended for routine infant immunization, beginning at 2 months of age. DTaP-IPV, with or without Hib vaccine, is authorized for use in children less than 7 years of age. DTaP-HB-IPV-Hib vaccine is authorized for use in children 6 weeks to 23 months of age and may be given to children aged 24 months to less than 7 years, if necessary. DTaP-IPV or Tdap-IPV vaccine should be used as the booster dose for children at 4 to 6 years of age. Children 7 years of age and older should receive the adolescent/adult formulation of diphtheria-tetanus-pertussis-containing vaccine, with or without polio, (Tdap or Tdap-IPV) as it contains less diphtheria toxoid than preparations given to younger children and is less likely to cause reactions in older children. Tdap vaccine should be administered to adolescents at 14 to16 years of age as the first 10-year booster dose; Tdap-IPV vaccine should be used if IPV vaccine is also indicated.
Adults who have not previously received a primary series (at least 3 doses) of tetanus toxoid-containing vaccine should receive one dose of Tdap-IPV vaccine followed by two doses of Td-IPV, vaccine. There is new evidence that a booster dose of Td vaccine may not be required every 10 years. Until a full review of the literature has been completed, a booster dose of Td vaccine is recommended every 10 years. Until a full review of the literature has been completed, a booster dose of Td vaccine is recommended every 10 years.
Refer to Schedule and Booster doses and re-immunization. Refer to Diphtheria Toxoid, Pertussis Vaccine, Poliomyelitis Vaccine, Haemophilus influenzae type b Vaccine and Hepatitis B Vaccine in Part 4 for additional information.
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors. When available, serologic testing for diphtheria and tetanus antitoxin concentrations may guide the need for continued immunization. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional general information.
Susceptible pregnant women may receive Td vaccine if it is indicated. There no evidence to suggest a risk to the fetus or to the pregnancy from immunization of the mother with Td vaccine. Neonatal tetanus may occur in infants born to unimmunized mothers under unhygienic conditions. For the use of Tdap vaccine during pregnancy refer to Pertussis Vaccine in Part 4. Refer to Immunization in Pregnancy and Breastfeeding Â in Part 3 for additional general information.
Premature infants in stable clinical condition should be immunized with a tetanus toxoid-containing preparation at the same chronological age and according to the same schedule as full-term infants. Infants born prematurely (especially those weighing less than 1,500 grams at birth) are at higher risk of apnea and bradycardia following vaccination. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization. Refer to Immunization of Infants Born Prematurely in Part 3 for additional general information.
Residents of long-term care facilities should receive all routine immunizations appropriate for their age and risk factors, including tetanus toxoid-containing vaccine. Refer to Immunization of Persons/Residents in Health Care Institutions in Part 3 for additional general information.
Diphtheria-tetanus-pertussis-polio-Hib-containing preparations may be administered to immunocompromised persons. When considering immunization of an immunocompromised person, consultation with the individual’s attending physician may be of assistance, in addition to the guidance provided in Immunocompromised persons in Diphtheria Toxoid and Haemophilus influenza type b Vaccine in Part 4. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised.
The antibody response to tetanus boosters given to adults with HIV or humoral immune deficiencies is suboptimal. Tetanus immunity is lost in approximately 50% of patients undergoing chemotherapy for lymphoma or leukemia.
Refer to Immunization of Immunocompromised Persons in Part 3 for additional general information.
People with neurological disorders with onset preceding immunization should receive all routinely recommended immunizations, including tetanus toxoid-containing preparations. Cases of Guillain Barré Syndrome (GBS) have been reported only very rarely following administration of a tetanus toxoid-containing vaccine, and the benefit of the vaccine normally outweighs this very small risk. Refer to Contraindications and Precautions for additional information. Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information.
Unimmunized or incompletely immunized travellers should receive diphtheria-tetanus-pertussis-polio-Hib-containing vaccine as appropriate for age. Refer to Diphtheria Toxoid and Poliomyelitis Vaccine in Part 4 for information regarding other components in tetanus toxoid-containing combination vaccines. Refer to Immunization of Travellers in Part 3 for additional general information.
Health care providers who see people newly arrived in Canada should review the immunization status and update immunization for these individuals. Refer to Immunization of Persons New to Canada in Part 3 for additional general information.
All health care workers should be immune to tetanus and receive a booster dose of Td vaccine every 10 years as recommended for all adults. All health care and child care workers, regardless of age, should receive a single dose of Tdap vaccine for pertussis protection if they have not been immunised previously with this vaccine in adulthood, even if they are not due for a tetanus and diphtheria booster. Refer to Immunization of Workers in Part 3 for additional general information.
The most important goals of post-exposure prophylaxis are removing the source of toxin production and neutralizing any toxin which may have been released. The first goal is best achieved by timely, thorough wound cleaning. The second goal is achieved by providing or inducing high circulating concentrations of tetanus antibody, which inactivate the toxin. Effective neutralizing antibody concentrations at the time of the injury can only be achieved by prior completion of the tetanus toxoid-containing vaccine series or immediate administration of tetanus immune globulin (TIg).
It is important to ascertain the number of doses of tetanus toxoid-containing vaccine that an injured person previously has received, any severe reaction that they have experienced with any previous dose, and the interval since the last dose. Post-exposure prophylaxis of individuals who are unimmunized or incompletely immunized (unknown or fewer than 3 doses) and who sustain more than a minor, clean wound, should consist of both TIg and tetanus toxoid-containing vaccine (as appropriate for age and immunization history), given at different injection sites and using separate needles and syringes. TIg provides immediate passive protection until the exposed person mounts an immune response to the tetanus toxoid-containing vaccine. The vaccine series should be completed subsequently unless there is a contraindication. Refer to Table 1 for additional information.
Previously immunized persons (3 or more doses) may require a booster dose of a tetanus toxoid-containing vaccine, depending on the interval since the last booster and the type of wound. A booster dose of tetanus toxoid-containing vaccine is recommended if ten or more years have elapsed for those with clean, minor wounds and if five or more years have elapsed, for all other wounds.
People who have a tetanus-prone injury and have experienced a severe injection site reaction following a tetanus toxoid-containing vaccine usually have very high serum antitoxin levels and should not receive routine or emergency booster doses of tetanus toxoid-containing vaccine for 10 years following the last dose. A tetanus-prone injury can be defined as an injury significantly contaminated with material likely to contain tetanus spores (i.e. soil, animal or human feces) or an injury with the presence of necrotic tissue.
Some individuals with humoral immune deficiency (e.g., HIV, agammaglobulinemia or hypogammaglobulinemia) may not respond adequately to tetanus toxoid-containing vaccine. Individuals with humoral immune deficiency who have wounds that are not minor and clean should receive both TIg and tetanus toxoid-containing vaccine, regardless of the time elapsed since the last booster. Table 1 summarizes the recommended use of immunizing agents in wound management.
|History of tetanus immunization||Clean, minor wounds||All other wounds|
|Tetanus toxoid-containing vaccineTable 1 - Footnote *||TIg||Tetanus toxoid-containing vaccineTable 1 - Footnote *||TIgTable 1 - Footnote **|
|Unknown or less than 3 doses in a vaccine seriesTable 1 - Footnote †||Yes||No||Yes||Yes|
|3 or more doses in a vaccine series and less than 5 years since last booster dose||No||No||No||NoTable 1 - Footnote ¶|
|3 or more doses in a vaccine series and more than 5 years but less than 10 years since last booster dose||No||No||Yes||NoTable 1 - Footnote ¶|
|3 or more doses in a vaccine series and more than 10 years since last booster dose||Yes||No||Yes||NoTable 1 - Footnote ¶|
Persons who have recovered from tetanus disease should receive tetanus toxoid-containing vaccine as recommended for people who not had the disease. Because tetanus is caused by the toxins produced by the tetanus bacterium and not by the bacterium itself, recovery from tetanus disease does not confer immunity.
immune globulin (TIg) for prophylaxis
The recommended dose of HYPERTET® S/D (TIg) for adults and children 7 years of age and older is 250 units by deep intramuscular injection. In small children less than 7 years old, the routine prophylactic dose of HYPERTET® S/D is 4 units/kg. However, it may be advisable to administer the entire contents of the vial or syringe of HYPERTET® S/D (250 units) regardless of the child’s size, since theoretically the same amount of toxin will be produced in the child’s body by the infecting tetanus organism as it will in an adult’s body.
Tetanus immune globulin (TIg) for treatment
When used in the treatment of tetanus, TIg should be administered intramuscularly in an effort to neutralize tetanus toxin in body fluids. It has no effect on toxin already fixed to nerve tissue. The optimal therapeutic dose has not been established.
Intramuscular injections are preferably administered in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal muscle should not be used as an injection site because of the risk of injury to the sciatic nerve.
Refer to Vaccine Safety for safety information.
For complete prescribing information, consult the product leaflet or information contained within Health Canada’s authorized product monographs available through the Drug Product Database. Refer to Passive Immunization Part 5 for additional general information.
Each dose of tetanus toxoid-containing vaccine is 0.5 mL
Route of administration
Tetanus toxoid-containing vaccines must be administered intramuscularly. Refer to Vaccine Administration Practices in Part 1 for additional information.
Infants and children (2 months to 6 years of age)
Routine tetanus immunization of infants: DTaP-IPV-Hib vaccine should be given at 2, 4, 6 and 12 to 23 months of age (generally given at 18 months of age).
If infant immunization for hepatitis B is undertaken, DTaP-HB-IPV-Hib vaccine may be used as an alternative to separately administered hepatitis B and DTaP-IPV-Hib vaccines. DTaP-HB-IPV-Hib vaccine is authorized for use in children 6 weeks to 23 months of age and may be given to children aged 24 months to less than 7 years, if necessary. DTaP-HB-IPV-Hib vaccine may be given at 2, 4, 6 and 12 to 23 months of age but the fourth dose is unlikely to provide significant additional hepatitis B protection and will increase cost. Alternative schedules may be used as follow:
If rapid protection is required for an infant, the first dose of DTaP-IPV-Hib or DTaP-HB-IPV-Hib vaccine can be given at 6 weeks of age. The first three doses may be administered at intervals of 4 weeks and, optimally, the fourth dose given 12 months after the third dose. The fourth dose may be given at a minimum interval of 6 months after the third dose in certain situations (e.g., travel) but must be administered at or after 12 months of age for sustained immunity.
Children less than 7 years of age not immunized in infancy: should receive three doses of DTaP-IPV (with or without Hib) vaccine with an interval of 8 weeks between doses, followed by a dose of DTaP-IPV vaccine 6 to 12 months after the third dose. A booster dose of either DTaP-IPV or Tdap-IPV vaccine should be administered at 4 to 6 years of age (school entry). The booster dose at 4 to 6 years of age is not required if the fourth dose of tetanus-toxoid containing vaccine was administered after the fourth birthday.
If rapid protection is required for a child less than 7 years of age and not immunized in infancy, the first three doses of vaccine may be administered at intervals of 4 weeks and, optimally, the fourth dose given 12 months after the third dose. The fourth dose may be given at a minimum interval of 6 months after the third dose in certain situations (e.g., travel).
Children who received a primary series) of tetanus toxoid-containing vaccine and a booster dose 6-12 months later as outlined above should receive a booster dose of either DTaP-IPV or Tdap-IPV vaccine at 4 to 6 years of age (school entry); and, 10 years later, a booster dose of Tdap vaccine at 14 to 16 years of age. The booster dose at 4 to 6 years of age is not required if the fourth dose of tetanus-toxoid containing vaccine was administered after the fourth birthday.
Children and adolescents (7 years to 17 years of age)
Children 7 years of age and older, not previously immunized, should receive three doses of Tdap-IPV vaccine with an interval of 8 weeks between the first two doses followed by a third dose administered 6 to 12 months after the second dose. A booster dose of Tdap vaccine should be administered 10 years after the last dose.
Adults (18 years of age and older)
Adults who have not previously received a primary series (at least 3 doses) of tetanus toxoid-containing vaccine should receive one dose of Tdap-IPV vaccine and two doses of Td-IPV vaccine. The dose of Tdap-IPV vaccine should be given first, followed 8 weeks later by a dose of Td-IPV vaccine. The second dose of Td-IPV vaccine should be given 6 to 12 months after the previous dose of Td-IPV vaccine.
The preschool booster dose of either DTaP-IPV or Tdap-IPV vaccine should be administered at 4 to 6 years of age. Adolescents should routinely receive a booster dose of Tdap vaccine at 14 to 16 years of age. Currently, booster doses of Td vaccine are recommended every 10 years. There is new evidence that booster doses of Td vaccine may not be required every 10 years and this evidence is currently under review. Adults who have not received an adult dose of pertussis-containing vaccine should receive one dose of Tdap vaccine, which can be administered regardless of the interval since the last dose of tetanus and diphtheria toxoid-containing vaccine. Refer to Schedule.
Serologic testing is not recommended before or after receiving tetanus toxoid-containing vaccine.
Tetanus toxoid-containing preparations should be stored in a refrigerator at +2°C to +8°C and must not be frozen. Refer to Storage and Handling of Immunizing Agents in Part 1 for additional general information. Refer to Passive Immunization in Part 5 for information regarding immune globulin storage.
Tetanus toxoid-containing vaccines may be administered concomitantly with routine vaccines at different injection sites using separate needles and syringes. Refer to Timing of Vaccine Administration in Part 1 for additional general information.
Refer to Vaccine Safety in Part 2 for additional general information. Refer to Diphtheria Toxoid, Pertussis Vaccine, Poliomyelitis Vaccine, Haemophilus influenzae type b Vaccine and Hepatitis B Vaccine in Part 4 for additional information regarding other components in tetanus toxoid-containing combination vaccines.
Redness, swelling and pain at the injection site are the most common adverse reactions to childhood tetanus toxoid-containing combination vaccines. A nodule may be palpable at the injection site and persist for several weeks. Abscess at the injection site has been reported. Â These events are most often related to administering the vaccine subcutaneously in error.
In clinical trials, injection site adverse reactions, including tenderness, erythema, swelling, or any combination, were reported in 10% to 40% of children after each of the first 3 doses of tetanus toxoid-containing vaccine. Mild systemic reactions such as fever, irritability fussiness or any combination were commonly reported (8% to 29%), as well as drowsiness (40% to 52%).
In two clinical studies, swelling (greater than 5 cm) and erythema were reported in 15 % to 20% of vaccinees after the fourth or fifth doses of DTaP vaccines. Extensive limb swelling (greater than 10 cm in diameter) possibly involving the entire proximal limb may occur in 2% to 6% of children. While these injection site reactions produce significant swelling, pain is generally limited. There is some evidence that children with extensive limb swelling following the fourth dose of a DTaP vaccine are at increased risk of such an event following the fifth dose. The presence of a large injection site reaction to a previous dose is not a contraindication to continuing the recommended schedule.
Among adults given a booster dose of Tdap vaccine, very common reactions include pain, redness and swelling at the injection site, headache, and fatigue. Fever and chills are common reactions. Adverse reactions following Td vaccine are similar. Overall, adverse reactions are less common in adults than adolescents. The interval between the childhood DTaP vaccine series or a dose of Td vaccine, and a dose of Tdap vaccine does not affect the rate of injection site or systemic adverse events.
Mild soreness at the injection site and slight temperature elevation may occur following TIg injection.
Serious adverse events are rare following immunization with tetanus toxoid-containing vaccines and, in most cases, data are insufficient to determine a causal association. Severe systemic reactions such as generalized urticaria, anaphylaxis, or neurologic complications have been reported rarely.
Serum sickness, brachial plexus neuropathy, encephalomyelitis and transverse myelitis have rarely been reported in association with tetanus vaccination.
Severe arthus-type injection site reactions are occasionally reported following receipt of diphtheria toxoid or tetanus toxoid-containing vaccines. There may be extensive painful swelling around the injection site, often involving the arm from shoulder to elbow and generally beginning 2 to 8 hours after injection. Such reactions are most often reported in adults, particularly those who have received frequent doses of diphtheria or tetanus toxoid-containing vaccines or both. Persons experiencing severe injection site reactions usually have very high serum antitoxin concentrations and should not receive further routine doses of Td vaccine for at least 10 years.
Angioneurotic edema, nephrotic syndrome, and anaphylaxis after injection have been reported rarely.
Trismus (inability to normally open the mouth) associated with tetanus toxoid immunization has rarely been reported. The pathogenesis is unexplained and it may be attributable to a reporting bias. Outcomes have been favourable.
Cases of Guillain-Barré Syndrome (GBS) or polyneuritis have been reported following administration of tetanus toxoid-containing vaccine and there has been one case report of relapsing GBS following each of three doses of vaccine. However, population studies have not supported a causal association.
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event felt to be temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization or a change in the frequency of a known AEFI. Refer to Reporting Adverse Events Following Immunization (AEFI) in Canada in Vaccine Safety Part 2 for additional information about AEFI reporting.
Tetanus toxoid-containing vaccines are contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container. Refer to Contents of Immunizing Agents Available for use in Canada in Part 1 for lists of all vaccines and passive immunizing agents available for use in Canada and their contents. For the tetanus toxoid-containing vaccines, potential allergens include:
There are no currently known potential allergens in ADACEL® or Td ADSORBED vaccines.
Hypersensitivity to yeast is very rare and a personal history of yeast allergy is not generally reliable. In situations of suspected hypersensitivity or non-anaphylactic allergy to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.
Administration of tetanus toxoid-containing vaccine should be postponed in persons with severe acute illness. Persons with minor acute illness, with or without fever, may be vaccinated.
It is prudent to not administer further doses of tetanus toxoid-containing vaccine to persons who develop GBS within 6 weeks of receiving such vaccine. Those who develop GBS outside the 6 week interval may receive subsequent doses of tetanus toxoid-containing vaccine. If there is a history of both Campylobacter infection (which has been associated with GBS) and receipt of a tetanus and diphtheria toxoid-containing vaccine within the 6 weeks before the onset of GBS, consultation with an infectious disease specialist is advised.
People who experience a severe injection site reaction following a dose of tetanus toxoid-containing vaccine should not be given another dose for at least 10 years.
The primary series of three doses tetanus toxoid-containing vaccine should be completed with an appropriate vaccine from the same manufacturer whenever possible. However, if the original vaccine is unknown or unavailable, an alternative combination vaccine from a different manufacturer may be used to complete the primary series. On the basis of expert opinion, an appropriate product from any manufacturer can be used for all booster doses. Refer to Principles of Vaccine Interchangeability in Part 1 for additional general information.
Centers for Disease Control and Prevention. The Pink Book: Epidemiology and Prevention of Vaccine Preventable Diseases. Updated 11th ed.; May 2009.
McQuillan G, Kruszon-Moran D, Deforest A et al. Â Serologic immunity to diphtheria and tetanus in the United States. Ann Intern Med 2002;136(9):660-66.
Wassilak S, Roper M, Murphy T et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, eds. Vaccines. 4th Â edition. Philadelphia: W.B. Saunders 2004;745-81. Â