Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (4)
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
Documents (16)
MenQuadfi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
April 19, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi : EPAR - Public assessment report
November 27, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for MenQuadfi
September 18, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi H/C/005084/P46/013 - Assessment report
October 16, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi-PAM-0000250392 : EPAR - Assessment report
June 11, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi : EPAR - Procedural steps taken and scientific information after authorisation
March 3, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi : EPAR - Medicine overview
November 27, 2020
OVERVIEW_DOCUMENT
MenQuadfi-H-C-005084-P46-009 : EPAR - Assessment report
February 8, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi-H-C-005084-P46-007 : EPAR - Assessment report
May 3, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi H/C/005084/P46/012 - Assessment report
July 30, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi : EPAR - Public assessment report
November 27, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
MenQuadfi : EPAR - Risk management plan
November 27, 2020
RISK_MANAGEMENT_PLAN_SUMMARY
MenQuadfi-H-C-005084-P46-008 : EPAR - Assessment report
February 8, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
MenQuadfi : EPAR - Product information
November 27, 2020
DRUG_PRODUCT_INFORMATION
CHMP summary of positive opinion for MenQuadfi
September 18, 2020
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
MenQuadfi : EPAR - All authorised presentations
November 27, 2020
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
How is MenQuadfi used?
Answer
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.
Question
How does MenQuadfi work?
Answer
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.
Question
What benefits of MenQuadfi have been shown in studies?
Answer
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.
Question
What are the risks associated with MenQuadfi?
Answer
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.
Question
Why is MenQuadfi authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of MenQuadfi?
Answer
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.
Question
Other information about MenQuadfi
Answer
MenQuadfi received a marketing authorisation valid throughout the EU on 18.11.2020.