Tetanus toxoid adsorbed is prepared by detoxification of the sterile
filtrate of broth cultures of Clostridium tetani with formalin and
heat. The toxoid is purified by chemical methods and is adsorbed onto
aluminium phosphate as adjuvant. Thiomersal is added as preservative.
The vaccine has the appearance of a greyish-white suspension and does
not contain any horse serum protein. Therefore it does not induce
sensitization to sera of equine origin. The vaccine meets the requirements
of W.H.O., EP and IP when tested by the methods outlined in W.H.O., TRS.
980(2014), EP and IP.
Each single 0.5 ml human dose contains
Aluminium Phosphate Al+++
|Preservative : 0.01%Thiomersal
The vaccine is used for the prevention of tetanus in infants,
children and adults, especially those liable to be exposed to tetanus
infection and persons engaged in outdoor activities e.g. gardeners,
farm workers and athletes.
Tetanus toxoid vaccine is also used in the prevention of neonatal
tetanus by immunizing women of childbearing age, and also in the
prevention of tetanus following injury. The vaccine can be safely
and effectively given simultaneously with BCG, Measles, Polio vaccines
(IPV and OPV), Hepatitis B and Yellow fever vaccine, Haemophilus
influenzae type b, Varicella vaccine and Vitamin A
APPLICATION AND DOSAGE
The full basic course of immunization against tetanus toxoid
consists of two primary doses of 0.5 ml at least four weeks apart,
followed by the third dose 6-12 months later. To maintain a high
level of immunity further 0.5 ml. booster doses are recommended
at every feasible interval (for adults usually 5 to 10 years).
PROTECTION OF THE NEWBORN AGAINST TETANUS
For prevention of neonatal tetanus, tetanus toxoid is recommended
for immunization of women of childbearing age, and especially pregnant
women. Tetanus toxoid may be safely administered during pregnancy
and should be given to the mother at first contact or as early as
possible in pregnancy. A five dose schedule is recommended for
previously unimmunized women of childbearing age : after the basic
course of immunization with three doses, two additional booster
doses should be given, at least one year after the previous dose or
during the subsequent pregnancy.
VACCINATION OF INJURED PERSONS
For those subjects who have proof of either completing their
course of primary immunizations containing tetanus toxoid or receiving
a booster shot within the previous 5 years no additional dose of
tetanus toxoid is recommended.
If more than 5 years have elapsed, and infection with tetanus because
of injury or other cause is suspected, 0.5ml of the adsorbed tetanus
toxoid should be given immediately. Where the immunization history
is inadequate 1500 IU (3000 old AU) tetanus antiserum and 0.5ml
toxoid should be injected, with separate syringes, to different
body sites. (If available, 250 units of tetanus immune globulin
(human origin) can be substituted for the tetanus antiserum). A
second 0.5ml dose of toxoid is recommended after 2 weeks and a third
dose after a further 1 month. (A note of caution : if horse-origin
tetanus antiserum is used in prophylaxis, the patient should be
tested for sensitivity to horse serum protein prior to its administration.
It is desirable to have 1 ml of Adrenaline solution (1 : 1000) immediately
available and the normal precautions followed when injecting antitoxins).
METHOD OF INOCULATION
Tetanus toxoid should be injected intramuscularly into the deltoid
muscle in women and older children. If there are indications for
the use of tetanus toxoid in younger children, the preferred site
for intramuscular injection is the anterolateral aspect of the upper
thigh since it provides the largest muscular mass.
Only sterile needles and syringes should be used for each injection.
The vaccine should be well shaken before use.
Once opened, multi-dose vials should be kept between +2°C
Multi-dose vials of TT from which one or more doses of vaccine have
been removed during an immunisation session may be used in subsequent
immunisation sessions for upto a maximum of 4 weeks, provided that
all of the following conditions are met
The expiry date has not passed;
The vaccines are stored under appropriate cold chain conditions;
The vaccine vial septum has not been submerged in water;
Aseptic technique has been used to withdraw all doses;
The Vaccine vial monitor (VVM), if attached, has not reached the discard point
The vaccine should be visually inspected for any foreign particulate matter and
/ or variation of physical aspect prior to administration. In event of either
being observed, discard the vaccine.
Reactions are generally mild and confined to the site of injection.
Some inflammation may occur together with transient fever, malaise
and irritability. Occasionally a nodule may develop at the site
of injection but this is rare. An increased severity of reactions
to vaccination may be observed in subjects who have had many booster
CONTRAINDICATIONS AND WARNINGS
The vaccine should not be given to persons who showed a severe
reaction to a previous dose of tetanus toxoid. Immunisation should
be deferred during the course of any febrile illness or acute infection.
A minor febrile illness such as mild upper respiratory infection
should not preclude immunisation.
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE
SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCURS DUE TO ANY COMPONENT
OF THE VACCINE. For treatment of severe
anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml
of 1:1000 injection) given s/c or i/m. Single dose should not exceed
1 mg (1ml). For infants and children the recommended dose of adrenaline
is 0.01mg/kg (0.01ml/kg of 1:1000 injection). Single pediatric
dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment
of severe anaphylaxis is the prompt use of adrenaline, which can
be lifesaving. It should not be used at the first suspicion of anaphylaxis.
As with the use of all vaccines the vaccines should remain under
observation for not less than 30 minutes for the possibility of
occurrence of immediate or early allergic
reactions. Hydrocortisone and antihistaminics should be
available in addition to supportive measures such as oxygen inhalation.
There is an increased incidence of local and systemic reactions
to booster doses of tetanus toxoid when given to previously immunized
persons. Special care should be taken to ensure that the injection
does not enter a blood vessel.
IT IS EXTREMELY IMPORTANT WHEN THE PARENT, GUARDIAN, OR ADULT PATIENT
RETURNS FOR THE NEXT DOSE IN THE SERIES, THE PARENT, GUARDIAN, OR
ADULT PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY
SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS
If passive immunisation for tetanus is needed, TIG (Human) is the
product of choice. It provides longer protection than antitoxin
of animal origin and causes few adverse reactions.
As with other intramuscular injections, use with caution in patients
on anticoagulant therapy.
Immunosuppressive therapies may reduce the immune response to vaccines.
TT vaccine may be used in children with known or suspected HIV
infection. Although the data are limited and further studies are
being encouraged, there is no evidence to date of any increased
rate of adverse reactions using this vaccines in symptomatic or
asymptomatic HIV infected children.
STORAGE OF THE VACCINE.
The vaccine should be stored in a dry, dark place at a temperature
between 2-8°C. Transportation should also be at 2-8°C. DO
Thirty six months from the date of manufacture.
1 dose ampoule of 0.5ml.
10 dose vial of 5 ml.
20 dose vial of 10 ml.
THE VACCINE VIAL MONITOR (Optional)
Inner square lighter than outer
If the expiry date has not passed,
USE the vaccine.
At a later time, inner square still lighter than
If the expiry date has not passed, USE the vaccine.
Inner square matches colour of outer circle.
DO NOT use the vaccine.
Beyond the discard point:
Inner square darker than outer ring.
DO NOT use the vaccine.
Vaccine Vial Monitors (VVMs) are part of the label
on Tetanus Toxoid Vaccine Adsorbed supplied
through Serum Institute of India Ltd. The colour dot which appears
on the label of the vial is a VVM. This is a time-temperature
sensitive dot that provides an indication of the cumulative heat to
which the vial has been exposed. It warns the end user when exposure
to heat is likely to have degraded the vaccine beyond an acceptable
The interpretation of the VVM is simple. Focus on the central
square. Its colour will change progressively. As long as the colour
of this square is lighter than the colour of the ring, then the
vaccine can be used. As soon as the colour of the central square is
the same colour as the ring or of a darker colour than the ring,
then the vial should be discarded.