What is Synflorix?
Synflorix is a vaccine. It is a suspension for injection containing parts of the bacterium Streptococcus pneumoniae / em> (S. pneumoniae).
Synflorix is used to vaccinate infants and children between the ages of six weeks and two years against invasive diseases and acute otitis media (middle ear infection) caused by S. pneumoniae. Invasive disease develops when the bacterium spreads through the body causing serious infections such as septicemia (blood infection), meningitis (infection of the membranes surrounding the brain and spine) and pneumonia (infection of the lungs). What is Synflorix used for?
The medicine can only be obtained with a prescription.
How is Synflorix used?
The vaccination schedule of Synflorix depends on the age of the child and should be based on official recommendations.
- Infants aged six weeks to six months are given three doses with an interval of at least one month between doses. A fourth dose as a "booster" is recommended at least six months after the third dose, preferably , when the baby is between 12 and 15 months of age.
- Infants aged seven to 11 months receive two doses at least one month apart.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 12-23 months receive two doses at least two months apart. 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 receiving 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 defenses) to defend itself against a disease. When a person receives the vaccine, the immune system recognizes the parts of the bacterium contained in the vaccine as "foreign" and produces specific antibodies. The immune system
it will therefore be able to produce antibodies more rapidly if it is exposed to the bacterium again. This helps protect against the disease.
Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the "capsule" that surrounds the bacterium S. pneumoniae. These polysaccharides have been purified, then "conjugated" (attached) to a vector which helps to make them recognizable by the immune system. The vaccine is also "adsorbed" (fixed) on an aluminum compound to stimulate a better response.
Synflorix contains polysaccharides derived 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 around 56 to 90% of invasive disease cases in children under five years of age.
How has Synflorix been studied?
The effects of Synflorix were first tested in experimental models before being studied in humans.
The ability of Synflorix to activate antibody production (immunogenicity) was tested in only one main study involving 1,650 healthy infants aged six to 12 weeks. Synflorix was compared with another vaccine authorized in the European Union (EU) to protect children from infection with S. pneumoniae, 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 conducted to determine whether Synflorix guaranteed prevention of acute otitis media. The study included nearly 5,000 three-month-old infants and compared an experimental vaccine containing the same polysaccharides as Synflorix with another vaccine that it is not active against infection with S. pneumoniae (in this case, a vaccine against the hepatitis A virus.) The children were followed up until the end of their second year of life.
Further studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
What benefit has Synflorix shown during the studies?
In the immunogenicity study, Synflorix produced a response similar to that of the comparator vaccine for most of the polysaccharides of S. pneumoniae they have in common. Synflorix had "equivalent efficacy to that of the comparator vaccine in activating the production of antibodies against five of the polysaccharides that the two vaccines had in common (4, 9V, 14, 18C and 19F), but was less effective than the comparator vaccine. for two (6B and 23F). For the other three polysaccharides (1, 5, 7F), Synflorix was effective in activating antibody production.
In the study that looked at otitis media, the experimental vaccine containing the same polysaccharides as Synflorix was more effective than the comparator vaccine in preventing otitis media. The occurrence of the first episode of acute otitis media was approximately halved in the children receiving the vaccine compared with those receiving the comparator product. Based on a comparison of the immune response of Synflorix with that of the vaccine used in the study, it is expected that Synflorix may provide similar protection against acute otitis media caused by S. pneumoniae.
The other studies showed that although Synflorix produced a lower antibody response in infants and older children than the comparator vaccine, it met pre-established criteria and was considered acceptable in this group. Both Synflorix and the comparator vaccine showed increased antibody production after booster vaccinations.
What is the risk associated with Synflorix?
The most common side effects of Synflorix (seen in more than 1 in 10 patients) are pain, redness and swelling at the injection site, sleepiness, loss of appetite, fever and irritability. For the complete list of side effects reported with Synflorix , see the package leaflet.
Synflorix must not be used in children who may be hypersensitive (allergic) to the active substances or to any of the other substances. Children with a high fever should not receive the vaccine until they are cured, but they can receive the vaccine if they have a mild infection, eg. a cold.
As with all vaccines, if Synflorix is used in very premature infants, there is a risk of the babies going apnea (short interruptions in breathing). Their breathing should be monitored for up to three days after vaccination.
Why has Synflorix been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that the immune system response to Synflorix was comparable to that of the comparator vaccine, already authorized for the protection of children against the bacterium. S. pneumoniae in the EU. The Committee also took into account that Synflorix contains other polysaccharides derived from the types of S. pneumoniae which are responsible for diseases in Europe. The CHMP therefore decided that Synflorix's benefits are greater than its risks for active immunization against invasive diseases and acute otitis media caused by S. pneumoniae in infants and children from six weeks to two years of age. The committee recommended the granting of a marketing authorization for Synflorix.
Other information about Synflorix:
On March 30, 2009, the European Commission released GlaxoSmithKline Biologicals S.A. a "marketing authorization" for Synflorix, valid throughout the European Union.
For the full version of Synflorix EPAR, click here.
Last update of this summary: 03-2009.
The information on Synflorix - vaccine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
