What is Menveo?
Menveo is a vaccine. It consists of a powder and a solution to be mixed to obtain a solution for injection. Contains parts of the bacterium Neisseria meningitidis (N. meningitidis).
What is Menveo used for?
Menveo is used to protect adults and adolescents from the age of 11 from invasive diseases caused by four groups of the bacterium N. meningitidis (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 that surround 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 act 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 produces antibodies against them. When a person is exposed to the bacterium, these antibodies together with other components of the immune system will be able to destroy the bacteria and help protect against diseases.
Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from the four groups of the bacterium N. meningitidi: A, C, W135 and Y. These have been purified, then "conjugated" (bound) to a protein from the bacterium Corynebacterium diphtheria contributing thus improving the immune response.
What studies have been carried out on Menveo?
The effects of Menveo were first tested in experimental models before being studied in humans.
Menveo's ability to stimulate the production of antibodies (immunogenicity) was evaluated in a main study involving almost 4, 000 participants aged 11 years or older. Menveo has been compared with Menactra (a similar vaccine for protection against N. meningitidis). The main measure of effectiveness is a comparison between the capacity of Menveo and that of the comparison vaccine in stimulating the immune response against the four types of oligosaccharides N. meningitidis.
What benefit has Menveo shown during the studies?
The results of the main study indicated that Menveo had an efficacy equal to that of the comparator vaccine in stimulating an immune response against the four types of oligosaccharides N. meningitidis 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 patient in 10) are headache, nausea, malaise and pain, erythema (redness of the skin), hardening and itching at the injection site. 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 substances, including diphtheria toxoid. The vaccine should not be given to people who have had a life-threatening reaction to a vaccine containing similar substances in the past. Vaccination should be delayed in people with 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 diseases 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 on Menveo
On March 15, 2010, the European Commission issued a marketing authorization for Menveo to Novartis Vaccines and Diagnostics Srl, valid throughout the European Union. The marketing authorization is valid for five years and can be renewed after this period.
The full EPAR for Menveo can be found here. For more information on treatment with Menveo, read the package leaflet (also part of the EPAR).
Last update of this summary: 03-2010.
