Synflorix suspension for injection – pneumococcal conjugate vaccine for children up to 5 years

Synflorix is a pneumococcal conjugate vaccine (against Streptococcus pneumoniae bacteria). It contains purified polysaccharides from 10 pneumococcal serotypes bound to protein carriers and stimulates the child’s body to produce its own antibodies.

The vaccine is used to protect children from 6 weeks to 5 years of age against serious diseases caused by pneumococcus – meningitis, sepsis and bacteraemia – as well as middle ear infection and pneumonia. It is given by a doctor or nurse in a healthcare facility as an injection into a muscle.

What does Synflorix protect children from and what is the vaccination schedule?

Basic information about the medicine

What is Synflorix used for?

The vaccine protects children aged 6 weeks to 5 years against infections caused by Streptococcus pneumoniae, including:

• meningitis (inflammation of the membranes around the brain);
• sepsis and bacteraemia (bacteria in the bloodstream);
• middle ear infection;
• pneumonia.

How is Synflorix given?

• The vaccine is always given into a muscle – usually the thigh or upper arm.
• Infants aged 6 weeks to 6 months: usually 4 doses according to official recommendations – at least one month between doses, and the last (booster) dose at least 6 months after the third, from 9 months of age. Healthcare professionals may use a different schedule.
• Premature babies (born after 27 and before 37 weeks): 3 doses between 2 and 6 months, at least one month apart, and a booster at least 6 months after the last dose.
• Infants aged 7 to 11 months: 2 doses at least one month apart and a third (booster) dose in the second year of life, at least 2 months after the previous dose.
• Children aged 12 months to 5 years: 2 doses at least 2 months apart.
• Children at higher risk (HIV infection, sickle cell disease, damaged or absent spleen function) may receive the vaccine – the number and timing of doses are set by the doctor.
• Synflorix can be given at the same time as other childhood vaccines (diphtheria, tetanus, pertussis, Hib, polio, hepatitis B, MMR, varicella, rotavirus, meningococcal conjugate vaccines), at different injection sites.

Special patient groups

• Children over 5 years: safety and efficacy have not been established – vaccination is not recommended.
• Children with weakened immunity (e.g. HIV, immunosuppressive therapy) may not be fully protected.
• Babies born at or before 28 weeks of pregnancy: for 2–3 days after vaccination the intervals between breaths may be longer – the doctor may monitor breathing.

Contraindications – when the vaccine must not be given

• allergy of the child to the active substances or excipients of the vaccine (itchy rash, shortness of breath, swelling of the face or tongue);
• severe infection with a high temperature (over 38 °C) – vaccination is postponed until recovery.

Precautions and warnings

• Bleeding problems or easy bruising – consult the doctor before vaccination.
• In children aged 2 years and older, fainting may occur just before or after an injection – tell the doctor if this has happened before.
• The vaccine protects only against infections caused by the serotypes it contains.

Interactions with other medicines and vaccines

• Tell the doctor if the child takes other medicines or has recently received another vaccine; medicines affecting the immune system may reduce effectiveness.
• The doctor may recommend a fever-reducing medicine (e.g. paracetamol) before or immediately after vaccination – especially when given together with whole-cell pertussis vaccines and in children with previous febrile convulsions. If paracetamol is given at that time, antibody levels may be slightly reduced.

Pregnancy and breast-feeding

Not applicable – the vaccine is intended for children up to 5 years.

Driving and using machines

Not applicable.

Possible side effects

• Very common (more than 1 in 10 doses): pain, redness and swelling at the injection site, temperature of 38 °C or higher, drowsiness, irritability, loss of appetite.
• Common (up to 1 in 10 doses): hardness at the injection site.
• Uncommon (up to 1 in 100 doses): itching, blood clot, bleeding or small lump at the injection site, nausea, diarrhoea, vomiting, unusual crying, temporary pauses in breathing in babies born at or before 28 weeks, headache, rash, extensive swelling of the vaccinated limb, hives.
• Rare (up to 1 in 1,000 doses): fits with or without fever, allergic skin reactions, collapse or episodes of unresponsiveness with pallor or bluish skin.
• Very rare (up to 1 in 10,000 doses): Kawasaki disease, severe allergic reactions (hives, swelling of the face or lips with difficulty breathing, collapse).
• The booster dose may increase the risk of side effects; in children over 12 months, injection-site pain becomes more likely with age.

Missed dose

If the child misses a scheduled dose, it is important to make a new appointment and agree with the doctor how to continue the schedule so that the child is protected.

Related information

The child’s vaccination schedule follows the current national immunisation calendar – ask your paediatrician which vaccines are planned for your child and when.

For measuring 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

• One dose (0.5 mL) contains 1 microgram polysaccharide each of serotypes 1, 5, 6B, 7F, 9V, 14 and 23F and 3 micrograms each of serotypes 4, 18C and 19F; conjugated to protein D (from non-typeable Haemophilus influenzae), tetanus toxoid (18C) and diphtheria toxoid (19F); adsorbed on aluminium phosphate (0.5 mg Al3+).
• Excipients: sodium chloride, water for injections. The vaccine is essentially sodium-free.
• Appearance and pack: turbid white suspension in a pre-filled glass syringe (0.5 mL) with 1 needle.
• Marketing authorisation holder: Evropa Lek Pharma d.o.o. Belgrade, Bore Stankovića 2 (licence transferred by decision 515-01-00301-21-001 of 29 July 2021). Manufacturer: GlaxoSmithKline Biologicals S.A., Rue de l’Institut, Rixensart, Belgium.
• Licence: 515-01-00710-20-001 of 13 January 2021 (renewal).

Storage

• Store in a refrigerator (2–8 °C). Do not freeze.
• Keep in the original package to protect from light; use immediately after opening.
• Shelf life: 4 years. Keep out of the sight and reach of children.

Frequently asked questions

From what age is Synflorix given?

The first dose can be given from 6 weeks of age, and the vaccine is intended for children up to 5 years. In older children safety and efficacy have not been established.

How many doses does a child receive?

Usually 4 doses in infants aged 6 weeks to 6 months (3 + booster in premature babies), 3 doses in children aged 7 to 11 months and 2 doses in children aged 1 to 5 years – the exact schedule is set by the doctor.

Is fever after the vaccine normal?

A temperature of 38 °C or higher is a very common side effect. Monitor it and give a fever-reducing medicine only on medical advice; in case of fits or very high fever, contact the doctor immediately.

Can Synflorix be given on the same day as other vaccines?

Yes. According to the leaflet, it can be given at the same time as other childhood vaccines, but at different injection sites.

Sources

• ALIMS – Patient information leaflet Synflorix suspension for injection in pre-filled syringe (PIL)
• ALIMS – Summary of product characteristics Synflorix suspension for injection in pre-filled syringe (SmPC)

Sources checked on: 25 October 2026.