MenQuadfi
Authorised
This medicine is authorised for use in the European Union
meningococcal group A, C, W-135 and Y conjugate vaccine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
MenQuadfi is a vaccine used to protect adults and children from the age of 12 months against invasive meningococcal disease caused by four groups of the Neisseria meningitidis bacteria (group A, C, W, 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 poisoning).
The vaccine contains substances from the outer coat of N. meningitidis bacteria.
MenQuadfi is given as a single injection into the shoulder muscle or on the side of the thigh. Some people can be given a booster dose.
MenQuadfi can only be obtained with a prescription and should be used according to available official recommendations. For more information about using MenQuadfi, see the package leaflet or contact your doctor or pharmacist.
MenQuadfi is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease.
MenQuadfi contains small amounts of sugars from the outer coat of four groups of the N. meningitidis bacteria: A, C, W and Y. When a person is given the vaccine, the immune system recognises the sugars as ‘foreign’ and makes antibodies against them. If the person later comes into contact with the bacteria, these antibodies, together with other components of the immune system, will be able to fight off the bacteria more effectively and so help protect the person against the disease.
The ability of MenQuadfi to trigger the production of antibodies (immunogenicity) was assessed in seven main studies involving over 9,000 participants aged 1 year or older. MenQuadfi was compared with several other similar vaccines against N. meningitidis. Results showed that a single injection of MenQuadfi was as effective as the other vaccines in stimulating the body to produce antibodies that would protect against the four types of N. meningitidis.
The most common side effects with MenQuadfi (which may affect more than 1 in 10 people) are headache, muscle pain, malaise (feeling unwell) and pain at the site of injection. For the full list of side effects and restrictions of MenQuadfi, see the package leaflet.
MenQuadfi had been shown to be at least as effective as similar vaccines at stimulating an immune response to the four groups of the N. meningitidis bacteria in people of different age groups. Furthermore, MenQuadfi is well tolerated and there were no reports of serious or unexpected side effects. The European Medicines Agency therefore decided that MenQuadfi’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets MenQuadfi will complete studies to assess the effects of a second dose of the vaccine (a booster) after previous vaccination with MenQuadfi or a similar vaccine.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MenQuadfi have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of MenQuadfi are continuously monitored. Side effects reported with MenQuadfi are carefully evaluated and any necessary action taken to protect patients.
MenQuadfi received a marketing authorisation valid throughout the EU on 18.11.2020.
Product information
Latest procedure affecting product information:
VR/0000255856
27/02/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- MenQuadfi
- Active substance
- Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid
- Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid
- International non-proprietary name (INN) or common name
- meningococcal group A, C, W-135 and Y conjugate vaccine
- Therapeutic area (MeSH)
- Meningitis, Meningococcal
- Anatomical therapeutic chemical (ATC) code
- J07AH08
Pharmacotherapeutic group
VaccinesTherapeutic indication
MenQuadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.
The use of this vaccine should be in accordance with available official recommendations.
News on MenQuadfi
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