o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/531259/2016

EMEA/H/C/002226

EPAR summary for the public

Nimenrix

Meningococcal group A, C, W-135 and Y conjugate vaccine

This is a summary of the European public assessment report (EPAR) for Nimenrix. 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 Nimenrix.

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 (group 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 usually given as a single injection, preferably into the shoulder muscle. It can be given into the thigh muscle in children under 2 years old.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Nimenrix may also be used as a booster vaccine in people who have already been vaccinated with Nimenrix or another meningococcal 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 ready 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 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 aged 12 months or more. 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.

Studies also showed that when Nimenrix was given as a booster to people several years after they had been vaccinated with Nimenrix or another meningococcal vaccine, it increased the level of antibodies.

What is the risk associated with Nimenrix?

The most common side effects with Nimenrix given a s a single injection (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 tiredness. Side effects after booster vaccination with Nimenrix are generally similar to those after primary vaccination, but diarrhoea, vomiting and nausea are also very common. For the full list of all side effects and restrictions with Nimenrix, see the package leaflet.

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.

Nimenrix

EMA/531259/2016    Page 2/3

What measures are being taken to ensure the safe and effective use of Nimenrix?

The company that marktes Nimenrix will carry out a study to assess how long the protective immune response provided by one or two doses of Nimenrix lasts in young children under 2 years old.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nimenrix have also been included in the summary of product characteristics and the package leaflet.

Other information about Nimenrix

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

The full EPAR for Nimenrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Nimenrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2016.

Nimenrix

EMA/531259/2016