What is Nimenrix?
Nimenrix is a vaccine. It consists of a powder and a solvent which are mixed to make a solution for injection. The powder is available in a vial, and the solvent is available in a pre-filled syringe or in a vial (a sealed container). Contains parts of the Neisseria meningitidis bacterium (N. meningitidis).
What is Nimenrix used for?
Nimenrix is used to protect adults, adolescents and children 12 months of age and older from invasive meningococcal disease caused by four groups of the N. meningitidis bacterium (A, C, W135 and Y). Invasive disease occurs when bacteria spread throughout the body causing serious infections such as meningitis (infection of the membranes surrounding the brain and spinal cord) and septicemia (blood infection).
The vaccine can only be obtained with a prescription.
How is Nimenrix used?
Nimenrix should be used in accordance with available official recommendations.
It is given as a single injection, preferably into the shoulder muscle. In children less than two years of age, it can be given into the thigh muscle.Nimenrix can also be used as a booster dose in subjects who have previously been treated with a common unconjugated polysaccharide vaccine, to enhance the level of protection.
How does Nimenrix work?
Vaccines work by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. When a person is vaccinated, the immune system recognizes the parts of the bacterium contained in the vaccine as "foreign" and produces antibodies to When the person is then exposed to the bacterium, these antibodies, along with other components of the immune system, will be able to destroy the bacteria and help protect against the disease.
Nimenrix contains small amounts of polysaccharides (sugars) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified and then "conjugated" (bound) to the tetanus toxoid carrier protein (a weakened tetanus toxin which does not cause disease, also used in the tetanus vaccine), as this improves the immune response to the vaccine.
How has Nimenrix been studied?
The effects of Nimenrix were first tested in experimental models before being studied in humans.
The ability of Nimenrix to trigger antibody production (immunogenicity) was evaluated in five main studies involving over 4,000 participants. Nimenrix was compared with several other similar vaccines against N. meningitidis in subjects of various age groups, starting at 12 months. As the main measure of effectiveness, it was assessed whether the ability of Nimenrix to stimulate an immune response against the four types of N. meningitidis polysaccharides, and therefore to kill bacteria, were equal to that of the comparator vaccines.
What benefit has Nimenrix shown during the studies?
The studies showed that Nimenrix was as effective as the comparator vaccines in stimulating an immune response against all four types of N. meningitidis polysaccharides in subjects of different age groups. The number of subjects who had an immune response. against polysaccharides with Nimenrix was similar to that seen with comparator vaccines. Studies have also shown that when given to subjects previously treated with a common unconjugated polysaccharide vaccine, Nimenrix increases antibody production, albeit to a lesser extent. than in previously unvaccinated subjects.
What is the risk associated with Nimenrix?
The most common side effects with Nimenrix (seen in more than 1 in 10 patients) are loss of appetite, irritability, sleepiness, headache, fever, swelling, pain and redness at the injection site and tiredness. For the complete list. for side effects reported with Nimenrix, see package leaflet.
Nimenrix must not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients.
Why has Nimenrix been approved?
According to the CHMP, Nimenrix had been shown to be at least as effective as the comparator vaccines in stimulating an immune response to the four groups of the N. meningitidis bacterium in individuals of different age groups. The Committee found that Nimenrix offered the benefits of conjugate vaccines. compared to conventional vaccines, producing among other things a strong immune response in young children. Nimenrix is well tolerated, and the CHMP considered that it can be safely administered with other vaccines commonly used in different age groups. The CHMP therefore decided that Nimenrix's benefits are greater than its risks and recommended that it be released. "marketing authorization" for the medicinal product.
What information is still awaited for Nimenrix?
The company that produces Nimenrix will carry out studies to evaluate the duration of the protective immune response allowed by Nimenrix in children under two years of age and in older people, considering, among other things, the effects produced by the administration of a booster dose.
More information about Nimenrix
On 20 April 2012, the European Commission issued a "Marketing Authorization" for Nimenrix, valid throughout the European Union.
For more information about Nimenrix therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 03-2012.
The information on Nimenrix - Meningococcal conjugate vaccine groups A, C, W135 and Y 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.
