This is a summary of the European public assessment report (EPAR) for Synflorix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Synflorix.
- What is Synflorix?
Synflorix is a vaccine. It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
- What is Synflorix used for?
Synflorix is used to vaccinate infants and children aged between six weeks and five years against invasive disease and acute otitis media (infection of the middle ear) caused by S. pneumoniae. Invasive disease occurs when the bacterium spreads through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia (infection of the lungs).
The medicine can only be obtained with a prescription.
- How is Synflorix used?
The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.
- Infants aged between six weeks and six months are given three doses with an interval of at least one month between each dose, with the first dose usually given at two months of age. It is recommended that a fourth dose be given as a ‘booster’ at least six months after the third dose, preferably when the child is between 12 and 15 months of age.
- When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), two doses may be given two months apart, from the age of two months, followed by a booster at least six months later.
- Prematurely born babies (born between 27 and 36 weeks gestation) are given three doses with an interval of at least one month between each dose, with the first dose given at two months of age. It is recommended that a fourth dose be given as a ‘booster’ at least six months after the third dose.
- Infants aged between seven and 11 months are given two doses with an interval of at least one month between them. It is recommended that a third dose be given as a ‘booster’ at least two months after the second dose, during the child’s second year of life.
- Infants aged between 12 months and five years are given two doses with an interval of at least two months between them. The need for a booster dose in this age group has not been established.
The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children. It is recommended that all children who receive the first dose of Synflorix complete the full vaccination course.
- How does Synflorix work?
Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again. This helps to protect against the disease.
Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule’ that surrounds the S. pneumoniae bacterium. These polysaccharides have been purified, then ‘conjugated’ (attached) to a carrier to help them to be recognised by the immune system. The vaccine is also ‘adsorbed’ (fixed) onto an aluminium compound to stimulate a better response.
Synflorix contains the polysaccharides from 10 different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). In Europe, it is estimated that these are responsible for about 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of five years.
- How has Synflorix been studied?
The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between six and 12 weeks. Synflorix was compared with another vaccine that is authorised in the European Union (EU) to protect children against S. pneumoniae infection, and which contains seven of the 10 polysaccharides included in Synflorix. The study compared the immunogenicity of the two vaccines against the different polysaccharides.
Another main study was carried out to determine whether Synflorix would prevent acute otitis media. The study involved almost 5,000 infants aged three months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae infection (in this case, a vaccine against hepatitis-A virus). The children were followed up until the end of their second year of life.
Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children. In particular, two clinical studies in children aged two to five years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups. The children received one dose of Synflorix in the first study and two doses in the second study.
- What benefit has Synflorix shown during the studies?
In the immunogenicity study, Synflorix produced a similar response to the comparator vaccine for the majority of the S. pneumoniae polysaccharides they share in common. Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F). For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
In the study looking at otitis media, the investigational vaccine containing the same polysaccharides as Synflorix was more effective than the comparator in preventing otitis media. The occurrence of the first episode of acute otitis media was approximately halved among children who were given the vaccine compared with those given the comparator. Based on a comparison of the immune response of Synflorix with the vaccine used in the study, it is expected that Synflorix would provide similar protection against acute otitis media caused by S. pneumoniae.
The additional studies in infants and older children showed that although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled predefined criteria and was considered acceptable in this group. Both Synflorix and the comparator showed an increase in antibody production following booster vaccinations.
When Synflorix was tested in two to five years olds, the response to Synflorix was similar to the younger age group, with better results in children who received two doses.
- What is the risk associated with Synflorix?
The most common side effects with Synflorix were pain, redness and swelling at the injection site, drowsiness, loss of appetite, irritability and fever in under two-year olds. The majority of these reactions were of mild to moderate severity and were not long-lasting. For the full list of all side effects reported with Synflorix, see the package leaflet.
Synflorix must not be used in children who are hypersensitive (allergic) to the active substances or any of the other ingredients. Children who have a severe fever should not receive the vaccine until they have recovered, but they can still be given the vaccine if they have a mild infection such as a cold.
- Why has Synflorix been approved?
The CHMP noted that the immune system’s response to Synflorix was comparable to that of the comparator vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU. The Committee also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe. The CHMP therefore decided that Synflorix’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about Synflorix
The European Commission granted a marketing authorisation valid throughout the European Union for Synflorix on 30 March 2009.
For more information about treatment with Synflorix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 15/01/2013 .
25/10/2012 Synflorix -EMEA/H/C/000973 -II/0044
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|Synflorix : EPAR - Product Information||BG = bălgarski||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||ES = español||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||CS = čeština||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||DA = dansk||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||DE = Deutsch||08/07/2009||15/01/2013|
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|Synflorix : EPAR - Product Information||IT = italiano||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||LV = latviešu valoda||08/07/2009||15/01/2013|
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|Synflorix : EPAR - Product Information||MT = Malti||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||NL = Nederlands||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||PL = polski||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||PT = português||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||RO = română||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||SK = slovenčina||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||SL = slovenščina||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||FI = suomi||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||SV = svenska||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||IS = Islenska||08/07/2009||15/01/2013|
|Synflorix : EPAR - Product Information||NO = Norsk||08/07/2009||15/01/2013|
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.
The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Synflorix : EPAR - Procedural steps taken and scientific information after authorisation||(English only)||08/07/2009||15/01/2013|
|Synflorix-H-C-973-II-16 : EPAR - Assessment Report - Variation||(English only)||25/10/2011|
|Synflorix-H-C-973-II-20 : EPAR - Assessment Report - Variation||(English only)||25/10/2011|
|Synflorix-H-C-973-II-14 : EPAR - Assessment Report - Variation||(English only)||25/10/2011|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Synflorix : EPAR - Public assessment report||(English only)||12/05/2009|
This medicine is approved for use in the European Union