What is Menveo?
Menveo is a vaccine. It consists of a powder and a solution that are mixed to make a solution for injection. Contains parts of the Neisseria meningitidis bacterium (N. meningitidis).
What is Menveo used for?
Menveo is used to protect adults and adolescents aged 11 years and older from invasive disease caused by four groups of the N. meningitidis bacterium (A, C, W135 and Y). It is indicated in subjects at risk of exposure to this bacterium. Invasive diseases occur 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 should be administered following 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.
How does Menveo work?
Vaccines work by "teaching" the immune system (the body's natural defenses) 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 makes antibodies against them. When a person is 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 disease.
Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from the four groups of the N. meningitidi bacterium: A, C, W135 and Y. These have been purified, then "conjugated" (bound) to a protein by the bacterium Corynebacterium diphtheria contributing therefore to improve the immune response.
How has Menveo been studied?
The effects of Menveo were first tested in experimental models before being studied in humans.
Menveo's ability to stimulate antibody production (immunogenicity) was evaluated in one main study involving nearly 4,000 participants aged 11 years and older. Menveo was compared with Menactra (a similar vaccine for protection against N. meningitidis). The main measure of effectiveness is a comparison of the ability of Menveo and that of the comparator vaccine to stimulate the immune response against the four types of N. meningitidis oligosaccharides.
What benefit has Menveo shown during the studies?
The results of the main study indicated that Menveo was as effective as the comparator vaccine in stimulating an immune response against the four types of N. meningitidis oligosaccharides in adults and adolescents. The number of subjects who had an immune response against oligosaccharides was similar for the two vaccines.
What are the risks associated with Menveo?
The most common side effects with Menveo (seen in more than 1 in 10 patients) are headache, nausea, malaise and pain, erythema (redness of the skin), induration and itching at the injection site. For the complete list of injection site side effects reported with Menveo, see the package leaflet.
Menveo must not be used in people who may be hypersensitive (allergic) to the active substances or to any of the other substances, including diphtheria toxoid. The vaccine should not be given to people who have had a life-threatening reaction to a vaccine that contains similar substances in the past. Vaccination should be delayed in people with 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) cause invasive disease and that Menveo offers wider protection than other existing vaccines. The Committee therefore decided that Menveo's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Menveo
On March 15, 2010, the European Commission issued Novartis Vaccines and Diagnostics S.r.l. a "Marketing Authorization" for Menveo, valid throughout the European Union. The "Marketing Authorization" is valid for five years and can be renewed after that period.
For the full version of Menveo's EPAR click here. For more information on Menveo therapy, read the package leaflet (included with the EPAR).
Last update of this summary: 03-2010.
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