ALDIPETE-T suspension for injection – DTP vaccine against diphtheria, tetanus and whooping cough for children aged 2 months to 5 years

ALDIPETE-T is a combined adsorbed vaccine against diphtheria, tetanus and whooping cough (pertussis), known as the DTP vaccine. It contains purified diphtheria and tetanus toxoids and killed whole cells of the bacterium Bordetella pertussis, adsorbed on aluminium phosphate. It is produced by the Institute of Virology, Vaccines and Sera “Torlak” in Belgrade.

The vaccine is intended for active immunisation of children aged 2 months to 5 years. It is given only in a healthcare institution, in line with the national immunisation schedule, and before each dose the doctor assesses the child’s health.

How is the DTP vaccine ALDIPETE-T given and what should parents know before and after vaccination?

Key facts about the medicine

What is ALDIPETE-T used for?

According to the patient leaflet and the Summary of Product Characteristics, ALDIPETE-T is indicated for active immunisation against diphtheria, tetanus and whooping cough in children aged 2 months to 5 years, as primary vaccination and booster.

How is the vaccine given?

• Primary vaccination: 3 doses of 0.5 mL each, starting at the age of 2 months, at intervals of no less than 4 weeks, according to the immunisation schedule and no later than the age of 5.
• Booster: one 0.5 mL dose one year after completion of the primary series, no later than the age of 5.
• Route: intramuscular injection into the deltoid muscle of the upper arm. If another injectable vaccine is given on the same day, it is given into the other arm with a separate syringe and needle.
• The vial should be shaken gently to obtain a uniform suspension and briefly brought to room temperature before injection.
• The vaccine is given only by a healthcare professional; dosing does not depend on meals.

Special patient groups

• Children older than 5 years: the vaccine is not used.
• Children with a personal or family history of seizures or other neurological disorders: special caution and careful monitoring for 2–3 days after vaccination are needed.
• Children with primary or acquired immunodeficiency can be vaccinated, but the immune response may be weaker.
• Thrombocytopenia or clotting disorders (e.g. haemophilia): the vaccine is not given because intramuscular injection is not allowed.

Contraindications – when the medicine must not be used

According to the leaflet, the vaccine must not be given (or its use is postponed or assessed case by case) in:

• serious allergic reaction (e.g. anaphylaxis) to any vaccine component or to a previous dose of DTP or DTaP vaccine
• encephalopathy (coma, reduced consciousness, prolonged seizures) without another cause within 7 days of a previous dose
• progressive neurological disease, including infantile spasms, untreated or inadequately treated epilepsy and progressive encephalopathy
• moderate to severe acute illness with or without fever – vaccination is postponed until the condition is stable
• fever ≥ 40.5 °C, collapse or shock-like state, persistent crying for 3 hours or more within 48 hours, a seizure within 3 days, or Guillain-Barré syndrome within 6 weeks after a previous dose – in these cases the doctor weighs benefits and risks

Precautions and warnings

• Before vaccination the doctor takes a detailed history of the child’s health and any previous hypersensitivity reactions.
• The institution must be equipped to treat anaphylactic shock.
• The vaccine must not be injected into a blood vessel.
• If the suspension has changed in appearance (colour, visible particles, sediment that does not resuspend) or has been frozen, it must not be used.
• The vaccine contains thiomersal as a preservative, which may cause an allergic reaction.

Interactions with other medicines, alcohol and food

ALDIPETE-T can be given at the same time as other vaccines if they are injected at different sites, but it must not be mixed with other vaccines or medicines in the same syringe. Immunosuppressive medicines (e.g. corticosteroids, corticotropin, alkylating cytostatics, antimetabolites) and radiotherapy may reduce the immune response to the vaccine. Interactions with food and drink are not applicable.

Pregnancy and breastfeeding

Not applicable – the vaccine is given only to children up to 5 years of age.

Driving and using machines

Not applicable – the vaccine is given only to children up to 5 years of age.

Possible side effects

According to the patient leaflet and the Summary of Product Characteristics, the following may occur:

• very common: fever (≥ 38 °C), irritability, restlessness, pain, swelling and redness at the injection site, loss of appetite
• common: drowsiness, headache, nausea and vomiting
• uncommon: malaise and general weakness, nodules at the injection site, dizziness, persistent crying lasting 3 hours or more
• rare: sterile abscess at the injection site, collapse or hypotonic-hyporesponsive episode (the child becomes floppy and poorly responsive), seizures with or without fever
• very rare: allergic reactions (rash, itching, hives) including anaphylaxis, encephalopathy, Guillain-Barré syndrome

Suspected side effects can be reported to the doctor or to the Medicines and Medical Devices Agency of Serbia (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: according to the leaflet, no data are available; the vaccine is dosed and given by a healthcare professional.
• Missed dose: the appointment is rescheduled with the child’s paediatrician in line with the immunisation schedule; the interval between doses must not be shorter than 4 weeks.
• Continuing vaccination after a reaction: the doctor decides on the next dose based on the reaction to the previous one.

Related information

• How long does a viral fever last in children and how can it be brought down?
• How to bring down a fever quickly

Composition, packaging and manufacturer

• One dose (0.5 mL) contains: suspension of inactivated Bordetella pertussis not less than 4 IU, concentrated and purified diphtheria toxoid not less than 30 IU, concentrated and purified tetanus toxoid not less than 40 IU.
• Excipients: aluminium phosphate (up to 1.25 mg Al), thiomersal 0.05 mg, sodium chloride 4.5 mg, sodium hydroxide, sodium hydrogen carbonate, water for injections.
• Appearance and pack: uniform whitish-yellowish suspension that forms a sediment on standing which resuspends on shaking; 5 mL glass vial (10 doses), 10 vials per carton.
• Marketing authorisation holder and manufacturer: Institute of Virology, Vaccines and Sera “Torlak”, Vojvode Stepe 458, Belgrade.
• ALIMS authorisation: 515-01-01430-20-001 of 19.04.2021.

Storage

• Store in a refrigerator (2–8 °C) in the original package; do not freeze – a frozen vaccine must not be used.
• Shelf life: 2 years; an opened multi-dose vial must be used within 5 days if kept at 2–8 °C.
• Storage and disposal are handled by the healthcare institution in line with medical waste regulations.

Frequently asked questions

How many doses of ALDIPETE-T does a child receive?

Primary vaccination consists of three 0.5 mL doses, starting at 2 months of age, at least 4 weeks apart. A booster is given one year after the primary series, no later than the age of 5.

Is it normal for a child to get a fever after the DTP vaccine?

Yes, fever (≥ 38 °C), irritability and pain, swelling or redness at the injection site are very common reactions. A temperature of 40.5 °C or higher, seizures, floppiness or persistent crying for more than 3 hours require urgent medical attention.

When is vaccination postponed?

In moderate to severe acute illness, with or without fever, vaccination is postponed until the condition is stable. In progressive neurological diseases and after certain reactions to a previous dose, the doctor decides.

Can ALDIPETE-T be given on the same day as other vaccines?

Yes, if the vaccines are given at different sites (e.g. opposite arms) with separate syringes and needles. Vaccines are never mixed in the same syringe.

Sources

• ALIMS – Patient leaflet ALDIPETE-T® (April 2021)
• ALIMS – Summary of Product Characteristics ALDIPETE-T® (authorisation 515-01-01430-20-001)
• ALIMS – New authorisations and renewals 16.02.–30.04.2021 (ALDIPETE-T®, 19.04.2021)

Sources checked on: 23 October 2026.