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Tetanus is an acute, often fatal, disease caused by an exotoxin 

produced by the bacterium Clostridium tetani. It is characterized 

by generalized rigidity and convulsive spasms of skeletal 

muscles. The muscle stiffness usually begins in the jaw (lockjaw) 

and neck and then becomes generalized. 

Although records from antiquity (5th century BCE) contain 

clinical descriptions of tetanus, it was in 1884 when tetanus 

was first produced in animals by injecting them with pus from 

a fatal human tetanus case. During the same year, tetanus was 

produced in animals by injecting them with samples of soil. 

In 1889, Kitasato Shibasaburo isolated the organism from a 

human, showed that it produced disease when injected into 

animals, and reported that the toxin could be neutralized by 

specific antibodies. In 1897, Edmond Nocard demonstrated 

the protective effect of passively transferred antitoxin, and 

passive immunization in humans was used for treatment and 

prophylaxis during World War I. A method for inactivating 

tetanus toxin with formaldehyde was developed in the early 

1920s. This led to the development of tetanus toxoid in 1924. 

It was first widely used during World War II. 

Clostridium tetani

The C. tetani bacterium is a spore-forming, gram-positive, 

slender, anaerobic rod. The organism is sensitive to heat 

and cannot survive in the presence of oxygen. The spores, 

in contrast, are extremely resistant to heat and the usual 

antiseptics. They can survive autoclaving at 249.8°F (121°C) 

for 10 to 15 minutes. The spores are also relatively resistant to 

phenol and other chemical agents. 

The spores are widely distributed in soil and in the intestines 

and feces of horses, sheep, cattle, dogs, cats, rats, guinea pigs, 

and chickens. Manure-treated soil may contain large numbers 

of spores. In agricultural areas, a significant number of human 

adults may harbor the organism. The spores can also be found 

on skin surfaces and in contaminated heroin. 

C. tetani produces two exotoxins, tetanolysin and 

tetanospasmin. Tetanospasmin is a neurotoxin and causes 

the clinical manifestations of tetanus. On the basis of weight, 

tetanospasmin is one of the most potent toxins known: the 

estimated minimum human lethal dose is 2.5 nanograms per 

kilogram of body weight (a nanogram is one billionth of a gram) 

or 175 nanograms for a 70-kg (154-lb) human. 

Tetanus

● Caused by exotoxin produced 

by bacterium Clostridium tetani

Characterized by generalized 

rigidity and convulsive spasms

First produced in animals 

in 1884

Organism isolated in 1889

Tetanus toxoid developed in 

1924 and widely used during 

World War II

Clostridium tetani

● Anaerobic gram-positive, 

spore-forming bacteria

● Spores found in soil and 

intestines and feces of 

some animals

● Spores resistant to heat 

and antiseptics

● Two exotoxins produced with 

growth of bacteria

Tejpratap S.P. Tiwari, MD; Pedro L. Moro, MD, MPH; and Anna M. Acosta, MD
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Pathogenesis

C. tetani usually enters the body through a wound. In the 

presence of anaerobic conditions, the spores germinate. 

Toxins are produced and disseminated via blood and 

lymphatics. Tetanospasmin, also referred to as tetanus toxin, 

acts at several sites within the central nervous system, 

including peripheral motor end plates, the spinal cord, 

and the brain, and in the sympathetic nervous system. The 

typical clinical manifestations of tetanus are caused when 

tetanus toxin interferes with the release of neurotransmitters, 

blocking inhibitor impulses. This leads to unopposed 

muscle contraction and spasm. Seizures may occur, and the 

autonomic nervous system may also be affected. 

Clinical Features

The incubation period is usually about 8 days, with a usual 

range of 1 to 21 days. In general, the incubation period is longer 

the further the injury site is from the central nervous system. 

Shorter incubation periods are also associated with severe 

disease and a higher chance of death. 

On the basis of clinical findings, three different forms of tetanus 

have been described. The most common type (more than 80% 

of reported cases) is generalized tetanus. The disease usually 

presents with a descending pattern. The first sign is trismus, 

or lockjaw, followed by stiffness of the neck, difficulty in 

swallowing, and rigidity of abdominal muscles. Other symptoms 

include elevated temperature, sweating, elevated blood 

pressure, and episodic rapid heart rate. Spasms may 

occur frequently and last for several minutes. Spasms continue 

for 3 to 4 weeks. Complete recovery may take months.

Localized tetanus is an uncommon form of the disease in which 

patients have persistent contraction of muscles in the same 

anatomic area as the injury. These contractions may persist for 

many weeks before gradually subsiding. Localized tetanus may 

precede the onset of generalized tetanus but is generally milder. 

Cephalic tetanus is a rare form of the disease, occasionally 

occurring with otitis media in which C. tetani is present in the 

flora of the middle ear or following injuries to the head. There is 

involvement of the cranial nerves, especially in the facial area. 

Neonatal tetanus is a form of generalized tetanus that occurs 

in newborn infants. Neonatal tetanus occurs in infants born 

without protective passive immunity because the mother is not 

immune. It usually occurs through infection of the unhealed 

umbilical stump, particularly when the stump is cut with an 

unsterile instrument. In neonatal tetanus, symptoms usually 

appear from 4 to 14 days after birth, averaging about 7 days.

Tetanus Pathogenesis

● Enters body through wound

● Spores germinate in 

anaerobic conditions 

● Toxin binds in central 

nervous system

● Interferes with 

neurotransmitter release to 

block inhibitor impulses

● Leads to unopposed muscle 

contraction and spasm

Tetanus Clinical Features

● Incubation period 8 days 

(range, 1 to 21 days)

● Three forms: Generalized (most 

common), local (uncommon), 

cephalic (rare)

● Generalized tetanus: Trismus 

(lockjaw), stiffness of the neck, 

difficulty swallowing, rigidity of 

abdominal muscles

■ Spasms continue for 

3 to 4 weeks

■ Complete recovery may 

take months
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Complications

Laryngospasm or spasm of the muscles of respiration leads 

to interference with breathing. Fractures of the spine or long 

bones may result from sustained contractions and convulsions. 

Hyperactivity of the autonomic nervous system may lead to 

hypertension or an abnormal heart rhythm. 

Nosocomial infections are common because of prolonged 

hospitalization. Secondary infections may include sepsis from 

indwelling catheters, hospital-acquired pneumonias, and 

decubitus ulcers. Pulmonary embolism is particularly a problem 

in persons who use drugs and elderly patients. Aspiration 

pneumonia is a common late complication of tetanus, found 

in 50% to 70% of autopsied cases. In recent years, tetanus 

has been fatal in approximately 11% of reported cases. Cases 

most likely to be fatal are those occurring in persons age 60 

years or older and unvaccinated persons. In about 20% of 

tetanus deaths, no obvious pathology is identified and death is 

attributed to the direct effects of tetanus toxin. 

Laboratory Testing

The diagnosis of tetanus is entirely clinical and does not depend 

upon bacteriologic confirmation. C. tetani is recovered from the 

wound in only 30% of cases and can be isolated from patients 

who do not have tetanus. Laboratory identification of the 

organism depends most importantly on the demonstration of 

toxin production in mice. 

Medical Management

All wounds should be cleaned. Necrotic tissue and foreign 

material should be removed. If tetanic spasms are occurring, 

supportive therapy and maintenance of an adequate airway 

are critical. 

Tetanus immune globulin (TIG) is recommended for persons 

with tetanus. TIG can only help remove unbound tetanus 

toxin. It cannot affect toxin bound to nerve endings. A single 

intramuscular dose of 500 units is generally recommended 

for children and adults, with part of the dose infiltrated 

around the wound if it can be identified. Intravenous 

immune globulin (IVIG) contains tetanus antitoxin and may 

be used if TIG is not available.

Because of the extreme potency of the toxin, tetanus disease 

does not result in tetanus immunity. Active immunization with 

tetanus toxoid should begin or continue as soon as the person’s 

condition has stabilized. 

Antibiotic prophylaxis against tetanus is neither practical nor 

useful in managing wounds; immunization plays the more 

important role. The need for active immunization, with or 

without passive immunization, depends on the condition of 

Tetanus Complications

● Laryngospasm

● Fractures

● Hypertension and/or abnormal 

heart rhythm

● Nosocomial infections

● Pulmonary embolism

● Aspiration pneumonia

● Death
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the wound and the patient’s immunization history. Rarely 

have cases of tetanus occurred in persons with a documented 

primary series of tetanus toxoid. 

Persons with wounds that are neither clean nor minor, and who 

have had fewer than 3 prior doses of tetanus toxoid or have 

an unknown history of prior doses, should receive TIG as well 

as tetanus toxoid vaccine. This is because early doses of toxoid 

may prime the immune system but not induce immunity. TIG 

provides temporary immunity by directly providing antitoxin. 

This ensures that protective levels of antitoxin are achieved 

even if an immune response has not yet occurred.

Guide to Tetanus Prophylaxis with TIG in Routine Wound Management

History of adsorbed 

tetanus toxoid-containing 

vaccines (doses)

Clean, minor 

wounds 

DTaP, Tdap 

or Td†

Clean, minor 

wounds

TIG‡

All other wounds*

DTaP, Tdap or Td†

All other wounds*

TIG§

Unknown or < 3 doses Yes No Yes Yes

≥3 No¶ No No** No

*

Such as, but not limited to, wounds contaminated with dirt, feces, soil, or saliva; puncture wounds; avulsions; and wounds 

resulting from missiles, crushing, burns, and frostbite.

†

DTaP is recommended for children younger than age 7 years. Tdap is preferred to Td for persons age 11 years or older who have 

not previously received Tdap. Persons age 7 years or older who are not fully immunized against pertussis, tetanus, or diphtheria 

should receive one dose of Tdap (preferably the first) for wound management and as part of the catch-up series; if additional tetanus 

toxoid-containing doses are required, either Td or Tdap vaccine can be used.

§

People with HIV infection or severe immunodeficiency who have contaminated wounds (including minor wounds) should also 

receive TIG, regardless of their history of tetanus immunizations.

¶

Yes, if ≥10 years since the last tetanus toxoid-containing vaccine dose.

**Yes, if ≥5 years since the last tetanus toxoid-containing vaccine dose.

Epidemiology

Occurrence

Tetanus occurs worldwide but is most frequently encountered 

in densely populated regions in hot, damp climates with soil 

rich in organic matter. 

Reservoir

Organisms are found primarily in the soil and intestinal tracts of 

animals and humans. 

Transmission

Transmission is primarily by contaminated wounds (apparent 

and inapparent). The wound may be major or minor. In 

recent years, a higher proportion of tetanus cases had minor 

wounds, probably because severe wounds are more likely to be 

appropriately managed. Tetanus may follow elective surgery, 

burns, deep puncture wounds, crush wounds, otitis media, 

dental infection, and animal bites.

Tetanus Epidemiology

● Reservoir

■ Soil and intestine of animals 

and humans

● Transmission

■ Contaminated wounds

● Temporal pattern 

■ Temperate climate: 

Peaks in summer

■ Tropical climate: 

Year-round, but may rise 

during wet seasons 

● Communicability

■ Not contagious
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Temporal Pattern

In temperate climates, tetanus peaks in the summer. In tropical 

climates, tetanus generally occurs year round, but may rise 

during the wet season in some areas.

Communicability

Tetanus is not contagious from person-to-person. It is the 

only vaccine-preventable disease that is infectious but 

not contagious.

Secular Trends in the United States

A marked decrease in mortality from tetanus occurred from the 

early 1900s to the late 1940s. In the late 1940s, tetanus toxoidcontaining vaccines were introduced into routine childhood 

vaccination and tetanus became a nationally notifiable disease. 

At that time, between 500–600 cases (approximately 0.4 cases 

per 100,000 population) were reported per year. 

After the 1940s, reported tetanus incidence rates declined 

steadily. Since the mid-1970s, about 50 to 100 cases 

(approximately 0.05 cases per 100,000) have been reported 

annually in the United States. More recently, from 2009–2018, 

an average of 29 (range 18–37) cases were reported per year. 

Of the 297 cases reported during this 10-year timeframe, there 

were 19 deaths, all in adults age 55 years or older. In 2018, 23 

tetanus cases were reported, with no deaths. 

Among children born during 2016–2017, 93.3% had received 

at least 3 doses of DTaP vaccine by age 24 months, and 80.6% 

had received at least 4 doses of DTaP vaccine by age 24 

months. Tdap coverage among adolescents age 13 through 

17 years reached 90.2% in 2019. Coverage with tetanus toxoid 

vaccines among adults is lower; the estimates for any dose of 

a tetanus toxoid-containing vaccine (Td or Tdap) among adults 

was 63.4% in 2017.

Tetanus Toxoid-containing Vaccines

Tetanus toxoid is combined with diphtheria toxoid as 

diphtheria and tetanus toxoid (DT) vaccine or tetanus and 

diphtheria toxoid (Td [Tenivac and Tdvax]) vaccine. Tetanus 

toxoid is also combined with both diphtheria toxoid and 

acellular pertussis vaccine as DTaP (Infanrix and Daptacel) 

or Tdap (Boostrix and Adacel) vaccines. Td contains reduced 

amounts of diphtheria toxoid compared with DT. DTaP and 

Tdap contain the same pertussis components, but Tdap 

contains a reduced quantity of some pertussis antigens and 

diphtheria toxoid. Boostrix contains a reduced quantity of 

tetanus toxoid compared to Infanrix. 

Tetanus Secular Trends 

in the United States

● 500-600 cases annually 

before vaccine

● Since the mid-1970s, ~50-100 

cases annually 

● In 2018, 23 cases were reported 

with no deaths

Tetanus Toxoid-containing 

Vaccines

● DT

● DTaP (Daptacel and Infanrix)

● Td (Tdvax and Tenivac)

● Tdap (Adacel and Boostrix)

● DTaP-HepB-IPV (Pediarix)

● DTaP-IPV/Hib (Pentacel)

● DTaP-IPV (Kinrix and Quadracel)

● DTaP-IPV-Hib-HepB (Vaxelis)
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Children younger than age 7 years should receive DTaP 

vaccine or DT vaccine (in instances where the pertussis vaccine 

component is contraindicated or where the physician decides 

that pertussis vaccine is not to be administered). Persons age 

7 years or older should receive Td vaccine or Tdap vaccine, 

even if they have not completed a series of DTaP or DT (Tdap 

would be off-label for children age 7 through 9 years, but is still 

recommended by ACIP). Tdap (Boostrix) is approved for persons 

age 10 years or older; Tdap (Adacel) is approved for persons age 

10 through 64 years. DTP vaccines are combined diphtheria and 

tetanus toxoids and whole cell pertussis vaccine, but none are 

currently licensed in the United States.

There are five combination vaccines that contain DTaP vaccine. 

DTaP-HepB-IPV (Pediarix) is licensed for the first 3 doses of 

the DTaP series among children age 6 weeks through 6 years. 

DTaP-IPV/Hib (Pentacel) is licensed for the first 4 doses of the 

component vaccines among children age 6 weeks through 

4 years. DTaP-IPV (Kinrix) is licensed only for the fifth dose of 

DTaP and fourth dose of IPV among children age 4 through 

6 years. DTaP-IPV (Quadracel) is licensed only for the fifth dose 

of DTaP and fourth or fifth dose of IPV among children age 4 

through 6 years. DTaP-IPV-Hib-HepB (Vaxelis) is licensed for use 

in children age 6 weeks through 4 years.

Characteristics 

Tetanus toxoid-containing vaccines are administered by 

intramuscular injection. Each dose of tetanus toxoid-containing 

vaccines contains aluminum as an adjuvant but no preservative. 

DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel), DTaP-IPVHib-HepB (Vaxelis), DTaP-IPV (Kinrix), and DTaP-IPV (Quadracel) 

contain neomycin and polymyxin B as antibiotics. DTaP-IPVHib-HepB (Vaxelis) contains streptomycin as an antibiotic. 

DTaP-HepB-IPV (Pediarix) and DTaP-IPV-Hib-HepB (Vaxelis) 

vaccines contain yeast protein. Presentations of some tetanus 

toxoid-containing vaccines contain latex rubber.

Vaccination Schedule and Use 

DTaP (Infanrix and Daptacel)

DTaP (diphtheria, tetanus toxoids, and acellular pertussis 

vaccine) is recommended for children age 6 weeks through 

6 years. The routine schedule is a primary series of 3 doses at 

age 2, 4, and 6 months, a booster dose between age 15 through 

18 months, and another booster dose between age 4 through 

6 years (total of 5 doses). The first 3 doses should be given at 

4- to 8-week intervals (minimum of 4 weeks). Dose 4 should 

follow dose 3 by no less than 6 months and should not be 

administered before age 12 months. 

Tetanus Toxoid-containing 

Vaccine Characteristics

● Administered by intramuscular 

injection

● Contains aluminum as 

an adjuvant

Tetanus Toxoid-containing 

Vaccination Schedule

● DTaP 

■ 3-dose primary series at 

age 2, 4, and 6 months 

■ Primary series interval of 

4- to 8-weeks and minimum 

interval 4 weeks

■ Boosters at age 15 through 

18 months and age 4 through 

6 years

■ Minimum interval for dose 4 

is 6 months from dose 3 and 

minimum age is 12 months

■ If dose 4 is given on or after 

4th birthday, the 5th dose 

is optional

■ DT is used in place of 

DTaP if child has a valid 

contraindication to 

pertussis vaccine
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21

Dose 4 of both brands of DTaP is recommended to be 

administered at age 15 through 18 months (15 through 20 

months for Daptacel). Dose 4 may be given as early as age 

12 months if at least 6 months have elapsed since dose 

3 and, in the opinion of the vaccine provider, the child is 

unlikely to return for an additional visit between age 

15 through 18 months. 

Children who received 4 doses before their fourth birthday 

should receive a fifth dose of DTaP before entering school. The 

fifth dose is not necessary (but may be given) if dose 4 in the 

series was given on or after the fourth birthday. Administering 

the fifth dose increases antibody levels and may decrease the 

risk of school-age children transmitting the disease to younger 

siblings who are not fully vaccinated. 

If a child has a valid contraindication to pertussis vaccine, DT 

should be used to complete the vaccination series. If the child 

was younger than age 12 months when the first dose of DT 

was administered (as DTP, DTaP, or DT), the child should receive 

a total of 4 DT doses. If the child was age 12 months or older 

at the time the first dose of DT was administered, 3 doses 

(with dose 3 administered 6 through 12 months after dose 2) 

will complete the primary DT series. If dose 4 of DTP, DTaP, or 

DT is administered before the fourth birthday, a fifth dose is 

recommended at age 4 through 6 years.

DTaP-HepB-IPV (Pediarix)

DTaP-HepB-IPV vaccine is approved for use as a 3-dose series 

for children age 6 weeks through 6 years. It is administered 

to infants at age 2, 4, and 6 months. The minimum intervals 

for DTaP-HepB-IPV vaccine are determined by the DTaP 

component. The 3 doses must be separated by at least 4 weeks 

between doses. Because the minimum age for the first dose 

of DTaP-HepB-IPV vaccine is 6 weeks, this vaccine cannot be 

used for the birth dose of hepatitis B (HepB) vaccine. The final 

dose of DTaP-HepB-IPV vaccine should be administered at 

age 24 weeks or older, the minimum age for completion of 

the hepatitis B vaccine series. When DTaP-HepB-IPV vaccine is 

used to provide 3 doses at age 2, 4, and 6 months (based on 

the DTaP and IPV schedules), this will result in a 4-dose HepB 

vaccine series, which is acceptable. 

DTaP-IPV/Hib (Pentacel)

DTaP-IPV/Hib vaccine is approved for use as a 4-dose series 

for children age 6 weeks through 4 years. It is administered to 

infants at age 2, 4, 6, and 15 through 18 months. The minimum 

intervals for DTaP-IPV/Hib vaccine are determined by the 

DTaP component. The first 3 doses must be separated by at 

least 4 weeks between doses. Dose 4 must be separated from 

dose 3 by at least 6 months, and should not be administered 

before age 12 months. When DTaP-IPV/Hib vaccine is used 
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to provide 4 doses at age 2, 4, 6, and between 15 through 18 

months (based on the DTaP and Hib schedules), an additional 

booster dose with IPV-stand alone or DTaP-IPV vaccine should 

be administered at age 4 through 6 years. This will result in a 

5-dose IPV vaccine series, which is acceptable.

DTaP-IPV-Hib-HepB (Vaxelis)

DTaP-IPV-Hib-HepB is approved for use as a 3-dose series 

for children age 6 weeks through 4 years. It is administered 

to infants at age 2, 4, and 6 months. The minimum intervals 

for DTaP-IPV-Hib-HepB vaccine are determined by the DTaP 

component. The 3 doses must be separated by at least 4 weeks 

between doses. Because the minimum age for the first dose of 

DTaP-IPV-Hib-HepB vaccine is 6 weeks, this vaccine cannot be 

used for the birth dose of hepatitis B (HepB) vaccine. The final 

dose of DTaP-IPV-Hib-HepB vaccine should be administered at 

age 24 weeks or older, the minimum age for completion of the 

hepatitis B vaccine series. When DTaP-IPV-Hib-HepB vaccine is 

used to provide 3 doses at age 2, 4, and 6 months (based on 

the DTaP and IPV schedules), this will result in a 4-dose HepB 

vaccine series, which is acceptable. 

DTaP-IPV (Kinrix)

DTaP-IPV (Kinrix) vaccine is approved only for dose 5 of DTaP 

vaccine and dose 4 of IPV vaccine in children age 4 through 

6 years whose previous DTaP vaccine doses have been with 

Infanrix and/or Pediarix for dose 1, 2, and 3 and Infanrix for 

dose 4. However, if DTaP-IPV (Kinrix) vaccine is administered to 

children who received another brand of DTaP vaccine for prior 

DTaP vaccine doses, or if administered as dose 1, 2, 3, or 4 of the 

DTaP vaccine series or dose 1, 2, or 3 of the IPV vaccine series, 

the dose of DTaP-IPV (Kinrix) does not need to be repeated.

DTaP-IPV (Quadracel)

DTaP-IPV (Quadracel) vaccine is approved only for dose 5 of 

DTaP vaccine and dose 4 or 5 of IPV vaccine in children age 4 

through 6 years who have received 4 doses of Pentacel and/or 

Daptacel vaccine. However, if DTaP-IPV (Quadracel) vaccine is 

administered to children who received another brand of DTaP 

vaccine for prior DTaP vaccines doses, or if administered as 

dose 1, 2, 3, or 4 of the DTaP vaccine series or dose 1, 2, or 3 of 

the IPV series, the dose of DTaP-IPV (Quadracel) does not need 

to be repeated.

Tdap (Boostrix and Adacel) and Td (Tenivac and Tdvax)

Both Tdap vaccines are approved by the FDA for a booster 

dose for persons who have completed the recommended 

childhood DTP/DTaP vaccination series. Boostrix is approved 

for persons age 10 years or older. Adacel is approved for a 

single dose in persons age 10 through 64 years. A second dose 

of Adacel is also licensed for administration 8 or more years 

Tetanus Toxoid-containing 

Vaccination Schedule

● Tdap

■ 1 dose at age 11 through 18 

for adolescents who have 

completed DTaP series

■ Booster dose of Td or Tdap 

every 10 years for all persons
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21

after the first Tdap dose and for use for tetanus prophylaxis 

when indicated for wound management if at least 5 years 

have elapsed since the previous receipt of any tetanus toxoidcontaining vaccine. Both Td vaccines are approved for use in 

persons age 7 years or older.

A single Tdap dose is recommended for adolescents age 11 

through 18 years who have completed the recommended 

childhood DTP/DTaP vaccination series, preferably at age 11 

through 12 years. Adults age 19 years or older who have not 

previously received Tdap should receive a single dose of Tdap. 

To reduce the burden of pertussis in infants, a dose of Tdap 

has been recommended during each pregnancy since 2012, 

although this practice is an off-label use.

All adolescents and adults should have received a primary 

series of at least 3 documented doses of tetanus and diphtheria 

toxoids-containing vaccine (i.e., DTaP, DTP, DT, or Td) during their 

lifetime. A person without such documentation should receive a 

series of 3 doses of tetanus- and diphtheria-containing vaccine. 

One of these doses, preferably the first, should be Tdap. The 

remaining 2 doses should be either Td or Tdap. 

For persons age 7 to 9 years who receive a dose of Tdap as 

part of the catch-up series, an adolescent Tdap dose should 

be administered at age 11 through 12 years. If a Tdap dose is 

administered at age 10 years or older, the Tdap dose may count 

as the adolescent Tdap dose. Either brand of Tdap may be used.

Adults age 19 years or older who previously have not received 

Tdap should receive a single dose of Tdap to protect against 

pertussis and reduce the likelihood of transmission. For adults 

age 19 through 64 years, either brand of Tdap may be used. 

Adults age 65 years or older should be vaccinated with Boostrix, 

if feasible. However, either vaccine administered to a person age 

65 years or older is immunogenic and would provide protection. 

A dose of either vaccine would be considered valid. 

Adolescents and adults who have not previously received 

Tdap, and have or anticipate having close contact with an 

infant younger than age 12 months (e.g., parents, siblings, 

grandparents, child care providers, and health care personnel) 

should receive a single dose of Tdap to protect against pertussis. 

Ideally, these persons should receive Tdap at least 2 weeks 

before beginning close contact with the infant.

Health care personnel should receive a single dose of Tdap 

as soon as feasible if they have not previously received Tdap, 

regardless of the time since their most recent Td vaccination. 

When Tdap is indicated (e.g., routine vaccination, catch-up 

vaccination, or pregnancy), it can be administered regardless 

of the interval since the last tetanus- or diphtheria-toxoidUse of Tdap 

● 1 dose Tdap during each 

pregnancy (off-label use)

● 1 dose Tdap for the 

following with no previous 

documentation of Tdap: adults, 

adolescents and adults who 

have or anticipate having close 

contact with an infant younger 

than age 12 months, and health 

care personnel

● 3 doses of tetanus- and 

diphtheria-containing vaccine 

(1 dose should be Tdap) for 

adolescents and adults 

without documentation of 

a primary series
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Tetanus

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containing vaccine. After receipt of Tdap, persons should 

continue to receive a dose of Td or Tdap for routine booster 

immunization against tetanus and diphtheria every 10 years 

unless needed sooner for tetanus prophylaxis as part of 

wound management.

Vaccination during Pregnancy

Pregnant women who have completed the childhood 

immunization schedule and were last vaccinated greater than 

10 years previously should receive a booster dose of tetanus 

toxoid–containing vaccine to prevent neonatal tetanus. 

The risk for neonatal tetanus is minimal if a previously 

unvaccinated woman has received at least 2 properly spaced 

doses of a tetanus toxoid–containing vaccine during pregnancy; 

at least 1 of the doses administered during pregnancy should 

be Tdap, administered according to published guidance. 

If more than 1 dose is needed, either Td or Tdap may be 

used. The 3-dose primary series should be completed at the 

recommended intervals. 

Immunogenicity and Vaccine Efficacy

After a primary series of 3 properly spaced doses of tetanus 

toxoid-containing vaccines in infants and a booster at 15 

through 18 months of age or 3 properly spaced doses in adults, 

essentially all recipients achieve antitoxin levels considerably 

greater than the protective level of 0.1 IU/mL. 

Efficacy of the tetanus toxoid has never been studied in a 

vaccine trial. It can be inferred from protective antitoxin levels 

that a complete tetanus toxoid series has an efficacy of almost 

100%. In the series of 233 cases from 2001–2008, only 7 cases 

(3%) had received a complete tetanus toxoid series with the last 

dose within the last 10 years. 

Antitoxin levels decrease with time. By 10 years after the last 

dose, most persons have antitoxin levels that only approach 

the minimal protective level. As a result, routine boosters are 

recommended every 10 years. 

In a small percentage of individuals, antitoxin levels fall below 

the minimal protective level before 10 years have elapsed. 

To ensure adequate protective antitoxin levels, persons who 

sustain a wound that is other than clean and minor should 

receive a tetanus booster if more than 5 years have elapsed 

since their last dose. 

Contraindications and Precautions 

to Vaccination

As with other vaccines, a history of a severe allergic reaction 

(anaphylaxis) to a vaccine component or following a prior 

dose is a contraindication to further doses. Moderate or severe 

Tetanus Toxoid-containing 

Vaccine Efficacy

● After valid 3-dose primary 

series and booster (children) 

or 3 valid doses (adults), 

essentially all recipients 

achieve antitoxin levels great 

than protective level

● Antitoxin levels decrease 

with time so boosters are 

recommended every 10 years

● Small percentage of individuals 

are unprotected before 10 

years, so booster for wound 

needed if more than 5 years 

have elapsed since last dose 
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acute illness (with or without fever) in a patient is considered 

a precaution to vaccination, although persons with minor 

illness may be vaccinated. If moderate to severe acute illness 

accompanies a wound that is neither clean nor minor, the risk 

of withholding tetanus-toxoid vaccine outweighs the risk of 

administering tetanus-toxoid vaccine, so the vaccine should be 

given as part of wound management.

Contraindications to combination vaccines that contain DTaP 

include the contraindications to the individual component 

vaccines (e.g., IPV, hepatitis B, Hib), but specific ingredients 

might differ. DTaP-HepB-IPV (Pediarix) and DTaP-IPV-HibHepB (Vaxelis) vaccines contain yeast. Presentations of some 

tetanus toxoid-containing vaccines contain latex rubber. 

DTaP-HepB-IPV (Pediarix), DTaP-IPV/Hib (Pentacel), DTaP-IPVHib-HepB (Vaxelis), DTaP-IPV (Kinrix), and DTaP-IPV (Quadracel) 

contain neomycin and polymyxin B. DTaP-IPV-Hib-HepB 

(Vaxelis) contains streptomycin.

Encephalopathy not attributable to another identifiable cause 

occurring within 7 days after vaccination with DTaP, DTP, or Tdap 

is a contraindication for DTaP and Tdap vaccination.

A progressive or unstable neurological disorder, uncontrolled 

seizures, or progressive encephalopathy is a precaution for DTaP 

and Tdap vaccination. For persons with a known or suspected 

neurologic condition, vaccination with DTaP or Tdap should 

be delayed until the condition has been evaluated, treatment 

initiated, and the condition stabilized. These conditions 

include the presence of an evolving neurologic disorder 

(e.g., uncontrolled epilepsy, infantile spasms, and progressive 

encephalopathy); a history of seizures that has not been 

evaluated; or a neurologic event that occurs between doses 

of vaccine. A family history of seizures or other neurologic 

diseases, or stable or resolved neurologic conditions (e.g., 

controlled idiopathic epilepsy, cerebral palsy, developmental 

delay), are neither contraindications nor precautions to DTaP or 

Tdap vaccination. 

Guillain-Barré syndrome within 6 weeks after a previous dose of 

tetanus toxoid-containing vaccine is a precaution for DTaP, Tdap, 

DT, and Td vaccination.

A history of Arthus-type hypersensitivity reactions after a 

previous dose of diphtheria toxoid-containing or tetanus toxoidcontaining vaccine is a precaution for DTaP, Tdap, DT, and Td 

vaccination; vaccination should be deferred until at 

least 10 years have elapsed since the last tetanus toxoidcontaining vaccine.

Diphtheria and Tetanus 

Toxoids-containing Vaccine 

Contraindications and Precautions

● Contraindication

■ Severe allergic reaction 

to vaccine component or 

following a prior dose

■ Encephalopathy not 

attributable to another 

identifiable cause within 7 

days after vaccination*

● Precaution

■ Moderate or severe acute 

illness

■ Progressive or unstable 

neurological disorder*

■ Uncontrolled seizures*

■ Progressive encephalopathy*

■ Guillain-Barré syndrome 

within 6 weeks after a 

previous dose of tetanus 

toxoid-containing vaccine**

■ History of Arthus-type 

hypersensitivity reactions 

after a previous dose of 

diphtheria toxoid- or tetanus 

toxoid-containing vaccine**

*DTaP and Tdap

**DTaP, DT, Tdap, Td
326

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 21

Vaccine Safety

DTaP vaccine may cause local reactions, such as pain, redness, 

or swelling. Local reactions have been reported in 20% to 

40% of children after each of the first 3 doses. Local reactions 

appear to be more frequent after the fourth and/or fifth doses. 

Mild systemic reactions such as drowsiness, fretfulness, and 

low-grade fever may also occur. Temperature of 101°F or higher 

is reported in 3% to 5% of DTaP recipients. These reactions are 

self-limited and can be managed with symptomatic treatment 

with acetaminophen or ibuprofen. 

Moderate or severe systemic reactions (such as fever of 105°F 

or higher, febrile seizures, persistent crying lasting 3 hours or 

longer, and hypotonic-hyporesponsive episodes) have been 

reported after administration of DTaP, but occur less frequently 

than among children who received whole-cell DTP. Rates of 

moderate or severe systemic reactions vary by symptom and 

vaccine but generally occur in fewer than 1 in 10,000 doses. 

Exaggerated local (Arthus-type) reactions are rarely reported 

but may occur following receipt of a vaccine containing 

diphtheria or tetanus toxoids. 

The most common adverse reaction following vaccination with 

both brands of Tdap is a local reaction, such as pain (66% to 

75%), redness (25%), or swelling (21%) at the site of injection. 

Temperature of 100.4°F or higher was reported by 1.4% to 5% of 

Tdap recipients and 1.1% to 5% of Td recipients. Tdap recipients 

also reported a variety of nonspecific systemic events, such as 

headache, fatigue and gastrointestinal symptoms.

The Institute of Medicine reported in 2011 that the evidence 

was inadequate to accept or reject a causal relation between 

receipt of diphtheria toxoid and tetanus toxoid-containing 

vaccine and encephalitis, encephalopathy, infantile spasms, 

seizures, ataxia, autism, acute disseminated encephalomyelitis, 

transverse myelitis, optic neuritis, onset of multiple sclerosis 

in adults, relapse of multiple sclerosis in adults, relapse of 

multiple sclerosis in children, Guillain-Barré syndrome, chronic 

inflammatory disseminated polyneuropathy, opsoclonus 

myoclonus syndrome, or Bell’s palsy. 

The most frequently reported adverse events after DTaP in the 

Vaccine Adverse Effect Reporting System (VAERS) and Vaccine 

Safety Datalink (VSD), two post-licensure surveillance systems, 

were consistent with observations from pre-licensure studies 

of these vaccines. When VAERS DTaP reports for each vaccine 

brand were compared individually with reports for all other 

inactivated vaccines in the VAERS database, no concerning 

patterns of adverse events were observed. 

Tetanus Toxoid-containing 

Vaccine Safety

DTaP

● Pain, redness, or swelling

■ 20%-40%

■ More frequent after dose 

4 or 5

● Temperature of 101°F

■ 3%-5%

● Moderate or severe systemic 

reactions

■ Fewer than 1 in 10,000 doses

● Arthus-type reactions are rare

Tdap, Td

● Pain, redness, or swelling

■ 21%-75%

● Temperature of 100.4°F or 

higher

■ 1.1%-5%
Tetanus

327

21

Routine VAERS surveillance for and VSD studies on adverse 

events following receipt of Tdap vaccines in persons aged 10 

through 64 years have provided reassuring data consistent 

with the prelicensure clinical trial safety data and have not 

demonstrated any associations between Tdap and the following 

rare adverse events: encephalopathy-encephalitis-meningitis, 

paralytic syndromes,seizures, cranial nerve disorders, and 

Guillain-Barré syndrome.

Vaccine Storage and Handling

DTaP, Td, and Tdap vaccines should be maintained at refrigerator 

temperature between 2°C and 8°C (36°F and 46°F). Manufacturer 

package inserts contain additional information. For complete 

information on best practices and recommendations, please 

refer to CDC’s Vaccine Storage and Handling Toolkit, www.cdc.

gov/vaccines/hcp/admin/storage/toolkit/storage-handlingtoolkit.pdf. 

Surveillance and Reporting of Tetanus

For information on guidance for state and local health 

department staff who are involved in surveillance activities for 

vaccine-preventable diseases, please consult the Manual for the 

Surveillance of Vaccine-Preventable Diseases, www.cdc.gov/

vaccines/pubs/surv-manual/chapters.html

Acknowledgements

The editors would like to acknowledge Susan Hariri, Fiona 

Havers, and Jennifer Liang for their contributions to this chapter.

Selected References 

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CDC. Pertussis vaccination: use of acellular pertussis vaccines 

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Advisory Committee on Immunization Practices (ACIP). MMWR

1997;46(No. RR-7):1–25. 

NOTES
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NOTES

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