Nimenrix

Active Substance: Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
Common Name: meningococcal group A, C, W 135 and Y conjugate vaccine
ATC Code: J07AH08
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
Active Substance: Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
Status: Authorised
Authorisation Date: 2012-04-20
Therapeutic Area: Meningitis, Meningococcal
Pharmacotherapeutic Group: Vaccines

Therapeutic Indication

Nimenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

What is Nimenrix?

Nimenrix is a vaccine. It is a powder and solvent that are mixed together 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 an ampoule (a sealed container). It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).

What is Nimenrix used for?

Nimenrix is used to protect adults, adolescents and children from the age of 12 months against invasive meningococcal disease caused by four groups of the bacterium N. meningitidis (A, C, W-135, and Y). Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).

The vaccine can only be obtained with a prescription.

How is Nimenrix used?

Nimenrix should be used according to available official recommendations.

Nimenrix is given as a single injection, preferably into the shoulder muscle. It can be given into the thigh muscle in children under two years old. Nimenrix may also be used as a booster vaccine in people who have already been vaccinated with a plain unconjugated polysaccharide vaccine, to reinforce the level of protection.

How does Nimenrix 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. When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill 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’ (attached) to a protein carrier called tetanus toxoid (a weakened toxin of tetanus which does not cause disease, also used in tetanus vaccine), because 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 the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants. Nimenrix was compared with several other similar vaccines against N. meningitidis in people of different age groups from 12 months and above. The main measure of effectiveness was whether Nimenrix was as good as the comparator vaccines at stimulating an immune response against the four types of N. meningitidis polysaccharides showing an ability to kill the bacteria.

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 people of different age groups. The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the comparator vaccines. The studies also showed that when Nimenrix is given to people who have already been vaccinated with a plain unconjugated polysaccharide vaccine it increased the production of antibodies, although less so than when given to previously unvaccinated people.

What is the risk associated with Nimenrix?

The most common side effects with Nimenrix (seen in more than 1 patient in 10) are loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the site of injection, and fatigue (tiredness). For the full list of all side effects reported with Nimenrix, see the package leaflet.

Nimenrix must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients.

Why has Nimenrix been approved?

The CHMP considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups. The Committee noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children. Nimenrix is well tolerated and the CHMP considered that it can be safely given together with other routinely used vaccines in the different age groups. Therefore, the CHMP decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.

What information is still awaited for Nimenrix?

The company that makes Nimenrix will carry out studies to assess how long the protective immune response provided by Nimenrix lasts in young children under two years old and in older people, including the effects of giving a booster dose.

Other information about Nimenrix

The European Commission granted a marketing authorisation valid throughout the European Union for Nimenrix on 20 April 2012.

For more information about treatment with Nimenrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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