Diphtheria, Tetanus and Pertussis Vaccine Adsorbed
is prepared by combining purified Diphtheria toxoid, purified Tetanus toxoid and
killed Bordetella pertussis bacilli. The antigens are 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 WHO, TRS. 980 (2014), EP and IP.
Each single 0.5 ml human dose contains
25Lf ( 30 IU)
Tetanus Toxoid 5Lf ( 40 IU)
16 OU (
Adsorbed on Aluminium Phosphate (Al+++)
Preservative : 0.01% Thiomersal
For the primary immunization of infants, above the age of six weeks, and of
pre-school children against diphtheria, tetanus and whooping cough. The vaccine
can be safely and effectively given simultaneously with BCG, Measles, Polio vaccines
(IPV and OPV), Hepatitis B, Yellow Fever Vaccine, Haemophilus
influenzae type b, Varicella vaccine and vitamin A supplementation.
For the purpose of primary immunization it is recommended that
3 doses of 0.5 ml should be inoculated on 3 separate occasions at 4 to 6 week
intervals. The first dose should be given at approximately 6 weeks of age. Reinforcing
injections of 0.5 ml. should be given 12 months after the primary immunization
and also between the ages of 4 to 6 years.
METHOD OF INOCULATION
DTP vaccine should be injected intramuscularly. The anterolateral aspect of
the upper thigh is the preferred site for injection. (An injection into a
buttocks may cause injury to the sciatic nerve and is not recommended). It must
only be injected into the skin as this may give rise to local reaction. 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 and +8°C.
Multi-dose vials of DTP 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
The expiry date has not passed.
are stored under appropriate cold chain conditions.
The vaccine vial septum
has not been submerged in water.
Aseptic technique has been used to withdraw
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.
How to use SII DTP vaccine and SII Hib vaccine as
SII DTP to be used to reconstitute Sii Hib vaccine for simultaneous
administration via single injection.
SII Hib vaccine must be reconstituted by adding the entire contents of SII DTP
ampoules or 0.5 ml of SII DTP from a multi dose vial of SII DTP. After the
addition of SII DTP to Hib pellet, the mixture should be well shaken until the
Hib pellet is completely dissolved in the SII DTP suspension. After
reconstitution the combined vaccine should be injected promptly. Inject 0.5 ml
suspension by intramuscular injection.
Mild local or systemic reactions are common. Some temporary swelling,
tenderness and redness at the site of injection together with fever occur in a
large proportion of cases. Occasionally severe reactions of high fever,
irritability and screaming develop within 24 hours of administration.
Hypotonic-hyporesponsive episodes have been reported. Febrile convulsions have
been reported at a rate of one per 12500 doses administered. Administration of
paracetamol at the time of and 4-8 hours after immunization decreases the
subsequent incidence of febrile reactions. The national childhood
encephalopathy study in the United Kingdom showed a small increased risk of
acute encephalopathy (primarily seizures) following DTP immunization. However
subsequent detailed reviews of all available studies by a number of groups,
including the United States Institute of Medicine, the Advisory Committee on
Immunization Practices, and the paediatric associations of Australia, Canada,
the United Kingdom and the United States, concluded that the data did not
demonstrate a causal relationship between DTP and chronic nervous system
dysfunction in children. Thus there is no scientific evidence that
hypotonic-hypo responsive episode and febrile convulsions have any permanent
consequences for the children.
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 vaccinee 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.
Special care should
be taken to ensure that the injection does not enter a blood vessel.
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 DOSE.
If DTP and TIG or Diphtheria Antitoxin are administered concurrently,
syringes and separate sites should be used.
As with other intramuscular injections,
use with caution in patients on anticoagulant therapy.
therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic
drugs and corticosteroids used in greater than physiologic dose may reduce the
immune response to vaccines.
CONTRAINDICATIONS AND WARNINGS
Known hypersensitivity to any component of the vaccine, or a severe
reaction to a previous dose of the vaccine or any of its constituents is an
absolute contraindication to subsequent doses of the vaccine or the specific
vaccine known to have provoked an adverse reaction. There are few
contraindications to the first dose of DTP - fits or abnormal cerebral signs in
the newborn period or other serious neurological abnormality are
contraindications to the pertussis component. In this case, DT should be given
instead of DTP vaccine.
Immunization should be postponed if the infant has an acute disease. However,
low grade fever, mild respiratory infections, malnutrition or diarrhoea should
not be considered as contraindications. Infants who have active or progressive
neurological disease including recent convulsions should not be given pertussis-
containing vaccines. Adsorbed DT vaccine should be given instead. A second or
subsequent dose of DTP vaccine should not be given to a child who had a severe
reaction like persistent screaming, shock, convulsions or encephalopathy to the
previous dose. Adsorbed DT vaccine should be given for the remainder of the
Individuals infected with human
immunodeficiency virus (HIV), both asymptomatic and symptomatic, should be
immunized with DTP vaccine according to standard schedules.
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 NOT FREEZE.
24 months from date of manufacture.
1 dose ampoule of 0.5 ml
2 dose ampoule/vial of 1 ml
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 Diphtheria, Tetanus and Pertussis 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.