Synflorix®

Immunisation schedule to all children at 6 weeks, 3 months, 5 months and 15 months of age.

All children born on or after 1 January 2008.

Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine.

Administration of Synflorix® should be postponed in individuals suffering from a fever over 38°C.

The presence of a minor infection is not a reason to delay immunisation.

The body’s immune response to Synflorix® is comparable to the response to Prevenar® for the pneumococcal bacteria types they have in common. Therefore, Synflorix® is expected to be as least as effective as Prevenar® in preventing serious infections. However, until Synflorix® has been used for many years, like Prevenar® has, there will be no data to show how much more effective it may be.

Synflorix® also generates protective immune responses for the additional types of pneumococcal bacteria in it, which are not covered by Prevenar®.

For all vaccines, similar to most medications, an extremely rare allergic reaction called ‘anaphylaxis’ can occur. Anaphylaxis after immunisation occurs about 1-3 times in every one million vaccine doses. All vaccinators will have training and equipment to deal with this situation in the unlikely event of it occurring.

No other serious responses to the vaccine have been identified.

Children can catch up missed doses of this vaccine anytime before their 5th birthday.

Synflorix® is not administered to children after their 5th birthday or adults.

Synflorix®

The vaccination schedule of Synflorix® is determined by the age of the infant/child on the day they receive their first dose of Synflorix® and whether they have had previous PCV doses of a pneumococcal conjugate vaccine (PCV), i.e. Prevenar®.

Healthy  children – previous PCV doses
Synflorix® can replace Prevenar® for scheduled immunisation visits or catch up pneumococcal immunisations at any point in the vaccination course.

Healthy children – no previous PCV doses
Refer to the Catch Up section on this web page.
Synflorix® can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

The benefit of vaccination in very premature infants (born ≤ 28 weeks of gestation) and those with a previous history of respiratory immaturity is high. Vaccination should not be withheld or delayed, however, respiratory monitoring should be considered for 48-72 hours due to the potential risk of apnoea.

Vaccination is by intramuscular injection into the vastus lateralis muscle in infants and in the deltoid muscle in toddlers and children. No data are available on subcutaneous administration of Synflorix®.

When Synflorix® is administered intramuscularly to infants or children with thrombocytopenia or another bleeding disorder since bleeding may occur. Firm pressure should be applied to the injection site (without rubbing) for at least ten minutes following injection.

Synflorix® is presented as a turbid white suspension. A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe/vial. This does not constitute a sign of deterioration.

Store between +2°C to +8°C. Protect from light.

The expiry date of the vaccine is the last day of the month in the year indicated on the packaging.

The body’s immune response to Synflorix® is comparable to the response to Prevenar® for the pneumococcal bacteria types they have in common. Therefore, Synflorix® is expected to be as least as effective as Prevenar® in preventing serious infections. However, until Synflorix® has been used for many years, like Prevenar® has, there will be no data to show how much more effective it may be.

Synflorix® also generates protective immune responses for the additional types of pneumococcal bacteria in it, which are not covered by Prevenar®.

Synflorix® will not protect against pneumococcal serogroups other than those included in the vaccine. Although antibody response to diphtheria toxoid, tetanus toxoid and Protein D (Protein D is highly conserved in all Haemophilus influenzae strains including NTHi) occurs, immunisation with Synflorix does not substitute routine immunisation with diphtheria, tetanus or Haemophilus influenzae type b vaccines.

The required number of doses to complete a primary course as an infant less than 12 months of age are determined by the age the infant is/was when they had their first PCV dose i.e.:

• First PCV at ≥ 6 weeks – ≤ 6 months - they require 3 doses before 12 months of age
• First PCV at ≥ 7 - ≤ 11 months - they require 2 doses before 12 months of age

Healthy children aged ≥ 12 - ≤ 59 months of age - who have had some but not all the required number of pneumococcal conjugate vaccine (PCV) doses before 12 months of age

• Do not count the infant doses when calculating PCV catch up doses
• These children require 2 doses eight weeks apart

Healthy children – no previous pneumococcal conjugate vaccine (PCV) doses

• Infants starting at ≥ 6 weeks – ≤ 6 months - 3 doses plus 1 dose after 12 months of age
• Infants starting at ≥ 7 - ≤ 11 months - 2 doses plus 1 dose after 12 months of age (at least eight weeks after the second dose)
• Children starting at ≥ 12 - ≤ 59 months - 2 doses eight weeks apart

A severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine.

Administration of Synflorix® should be postponed in individuals suffering from acute severe febrile illness (fever over 38°C). The presence of a minor infection is not a contraindication.