Infanrix hexa vaccine – six-in-one vaccine for infants and toddlers (diphtheria, tetanus, pertussis, hepatitis B, polio, Hib)

Infanrix hexa is a combined vaccine that protects against six diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases caused by the bacterium Haemophilus influenzae type b (Hib). The vaccine helps the child’s body make its own antibodies against these diseases and cannot cause the diseases it protects against.

The vaccine is intended for primary and booster immunisation of infants and toddlers from 6 weeks to 36 months of age, in line with official recommendations. The marketing authorisation holder in Serbia is Evropa Lek Pharma d.o.o. Belgrade, and the vaccine is manufactured by GlaxoSmithKline Biologicals S.A., Belgium.

What does the Infanrix hexa vaccine protect against and how is vaccination carried out?

Key facts about the medicine

What does Infanrix hexa protect against?

Infanrix hexa is indicated for primary and booster immunisation of infants and toddlers from 6 weeks to 36 months of age against:

• diphtheria – a serious bacterial infection of the airways whose toxin can damage nerves and the heart;
• tetanus – the bacteria enter through wounds and cause painful muscle spasms;
• pertussis (whooping cough) – a highly contagious airway infection with prolonged, severe coughing;
• hepatitis B – a viral liver infection that can become lifelong;
• poliomyelitis (polio) – a viral infection that can cause muscle paralysis;
• diseases caused by Haemophilus influenzae type b – e.g. meningitis and throat swelling.

As with other vaccines, protection may not be achieved in all vaccinated children.

How is vaccination carried out?

• One dose is 0.5 mL. The vaccine is prepared and given by a healthcare professional – as a deep injection into a muscle, with each subsequent dose at a different site. It is never given into a blood vessel or under the skin.
• Primary vaccination: two doses at least 2 months apart or three doses at least 1 month apart, according to the official immunisation schedule.
• Booster dose: mandatory, at least 6 months after the last primary dose – with the 3-dose schedule preferably before 18 months, and with the 2-dose schedule preferably between 11 and 13 months of age.
• Premature babies (born after at least 24 weeks of gestation) receive a 3-dose schedule with a mandatory booster.
• If your child misses a dose, make a new appointment with the doctor – all scheduled doses are needed for full protection.

Special patient groups

• Age: safety and efficacy in children older than 36 months have not been established.
• Premature babies (born at or before 28 weeks of gestation): longer gaps between breaths may occur for 2–3 days after vaccination, so breathing may need to be monitored for 48–72 hours after the first two or three doses.
• Children with weakened immunity or on immunosuppressive treatment: the immune response may be weaker.

Contraindications – when the medicine must not be used

• allergy to Infanrix hexa or any of its excipients, or to formaldehyde, neomycin or polymyxin;
• an allergic reaction to any previous vaccine against diphtheria, tetanus, pertussis, hepatitis B, polio or Hib;
• encephalopathy of unknown cause within 7 days of a previous vaccine containing a pertussis component (vaccination then continues with vaccines without the pertussis component);
• acute illness with fever (above 38 °C) – vaccination is postponed; a minor infection is not a contraindication.

Warnings and precautions

Talk to the doctor before vaccination if, after a previous whooping cough vaccine, your child had:

• a temperature above 40 °C within 48 hours;
• collapse or a shock-like state within 48 hours;
• persistent crying lasting 3 hours or more within 48 hours;
• seizures (with or without fever) within 3 days.

Also tell the doctor if your child has an undiagnosed or progressive brain disease or uncontrolled epilepsy, a tendency to febrile seizures (or a family history of them), bleeding problems or bruises easily, or was born prematurely. Medical help must be available after vaccination in case of a rare anaphylactic reaction. The vaccine contains para-aminobenzoic acid (may cause allergic reactions, including delayed ones, and exceptionally bronchospasm) and a very small amount of phenylalanine (important in phenylketonuria).

Interactions with other medicines, food and drink

• Tell the doctor about all medicines your child is receiving and about recently received vaccines.
• Infanrix hexa can be given at the same time as pneumococcal conjugate vaccine, meningococcal vaccines (C, ACWY, B), oral rotavirus vaccine and MMRV vaccine, at different sites. With pneumococcal or MMRV vaccine, fever after vaccination occurs more often.
• The doctor may advise a fever-reducing medicine (e.g. paracetamol) before or immediately after vaccination – prophylactic use is recommended in children with seizures or previous febrile seizures.
• In children on immunosuppressive treatment, the immune response may be weaker.

Pregnancy and breast-feeding

Infanrix hexa is not intended for adults, so there are no data on use during pregnancy and breast-feeding.

Driving and using machines

Not applicable – the vaccine is intended for infants and toddlers.

Possible side effects

Like all medicines, the vaccine can cause side effects. According to the leaflet (frequencies refer to vaccine doses):

• Very common (more than 1 in 10): sleepiness, loss of appetite, fever of 38 °C or higher, swelling, pain and redness at the injection site, unusual crying, irritability, restlessness.
• Common (up to 1 in 10): diarrhoea, vomiting, fever above 39.5 °C, swelling larger than 5 cm or a hard lump at the injection site, nervousness.
• Uncommon (up to 1 in 100): upper respiratory tract infection, tiredness, cough, extensive swelling of the vaccinated limb.
• Rare (up to 1 in 1,000): bronchitis, rash, swollen lymph glands, bleeding or bruising more easily (thrombocytopenia), longer gaps between breaths in premature babies, temporary pauses in breathing (apnoea), angioedema, swelling of the entire limb, blisters.
• Very rare: itching (dermatitis).

Very rarely, within 2–3 days of a whooping cough vaccine, collapse, periods of unconsciousness or reduced consciousness and seizures may occur. After hepatitis B vaccines, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy and meningitis have been reported extremely rarely, but a causal relationship has not been established.

Overdose, missed dose and stopping treatment

• Overdose: according to the SmPC, no case of overdose has been reported; the vaccine is dosed by a healthcare professional.
• Missed dose: contact the doctor and make a new appointment.
• Incomplete schedule: if your child does not receive all scheduled doses, they may not be fully protected.

Related information

For additional care and support with monitoring your child’s temperature after vaccination, see also the category Digital thermometers – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substances (after reconstitution, 0.5 mL): adsorbed diphtheria toxoid at least 30 IU; adsorbed tetanus toxoid at least 40 IU; pertussis toxoid 25 mcg; filamentous haemagglutinin 25 mcg; pertactin 8 mcg; hepatitis B surface antigen (rDNA, produced in yeast cells) 10 mcg; inactivated poliovirus type 1 (40 D-antigen units), type 2 (8) and type 3 (32); Hib polysaccharide (PRP) 10 mcg conjugated to approximately 25 mcg tetanus toxoid. Adsorbed on aluminium hydroxide (0.5 mg Al3+) and aluminium phosphate (0.32 mg Al3+).
• Excipients: Hib powder – anhydrous lactose; DTPa-HBV-IPV suspension – sodium chloride, medium 199 (amino acids including phenylalanine, mineral salts including sodium and potassium, vitamins including para-aminobenzoic acid), water for injections. May contain traces of formaldehyde, neomycin and polymyxin.
• Pack: glass vial with powder and glass pre-filled syringe with 0.5 mL suspension, with two needles.
• Marketing authorisation holder: Evropa Lek Pharma d.o.o., Bore Stankovića 2, Belgrade. Manufacturer: GlaxoSmithKline Biologicals S.A., Belgium.
• Marketing authorisation: 002639376 2024; first authorisation 20.03.2009, last renewal 23.06.2025.

Storage

• Store in a refrigerator (2 °C to 8 °C). Do not freeze.
• Store in the original package to protect from light.
• The reconstituted vaccine should be used immediately (stability has been shown for up to 8 hours at 21 °C).
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

How many doses of Infanrix hexa does a child receive?

Primary vaccination consists of two or three doses, followed by a mandatory booster at least 6 months after the last primary dose. The schedule is set by the official immunisation calendar and the doctor.

Is it normal for my child to have a fever after the vaccine?

Yes, a temperature of 38 °C or higher, redness, swelling and pain at the injection site, sleepiness and irritability are very common. If the temperature exceeds 40 °C, your child cries inconsolably for 3 hours or more, has seizures or stops responding, contact a doctor immediately.

Can my child be vaccinated with a cold?

A mild infection such as a cold is not a reason to delay, but discuss it with the doctor. In a severe infection with fever above 38 °C, vaccination is postponed.

Can Infanrix hexa be given together with other vaccines?

Yes. According to the SmPC it can be given at the same time as pneumococcal conjugate, meningococcal, rotavirus and MMRV vaccines, at different sites. With pneumococcal and MMRV vaccines, fever occurs more often.

Sources

• ALIMS – Summary of Product Characteristics, Infanrix® hexa powder and suspension for suspension for injection (SmPC, Serbian)
• ALIMS – Patient leaflet, Infanrix® hexa powder and suspension for suspension for injection (PIL, Serbian)

Sources checked on: 25 October 2026.