Menveo

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

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

What is Menveo?

Menveo is a vaccine. It is a powder and solution that are mixed together to make a solution for injection. It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).

What is Menveo used for?

Menveo is used to protect adults and adolescents aged 11 years and above against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y). It is used in people who are at risk of exposure to this bacterium. Invasive disease happens 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 should be given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Menveo used?

Menveo is given as a single injection into the shoulder muscle.The vaccine should be given according to official recommendations.

The vaccine can only be obtained with a prescription.

How does Menveo 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 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 disease.

Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated’ (attached) to a protein from the bacterium Corynebacterium diphtheriae. This helps to enhance the immune response.

How has Menveo been studied?

The effects of Menveo were first tested in experimental models before being studied in humans.

The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in one main study involving almost 4,000 participants aged 11 years and above. Menveo was compared with Menactra (a similar vaccine against N. meningitidis). The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides.

What benefit has Menveo shown during the studies?

The results of the main study showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and adolescents. The number of people who had an immune response against the oligosaccharides was similar for the two vaccines.

What is the risk associated with Menveo?

The most common side effects with Menveo (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), and pain, erythema (reddening of the skin), induration (hardening) and pruritus (itching) at the site of injection. For the full list of all side effects reported with Menveo, see the Package Leaflet.

Menveo should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid. The vaccine must not be given to anyone who has had a life-threatening reaction to a vaccine that contains similar components in the past.

Vaccination should be postponed in people who have a high fever.

Why has Menveo been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease and that Menveo provides broader protection than other available vaccines. The Committee therefore decided that Menveo’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Menveo

The European Commission granted a marketing authorisation valid throughout the European Union for Menveo to Novartis Vaccines and Diagnostics S.r.l on 15 March 2010. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 13/09/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

26/07/2011  Menveo -EMEA/H/C/001095 -II/0015

Contents

• 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.

Pharmacotherapeutic group

Bacterial vaccines

Therapeutic indication

Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.

The use of this vaccine should be in accordance with official recommendations.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents