InsertFile

All vaccines

MenQuadfi

MenQuadfi solution for injection

Manufacturer
SANOFI
Label last updated
26 Jan 2026
Source
Official SmPC ↗

Meningococcal ACWY vaccine for the teenage booster and for travel, from 12 months of age. Four sugars from the bacterium, each attached to a tetanus toxoid carrier protein.

55 findings, each with the section of the label it comes from.

Ingredients and materials

  • Neisseria meningitidis group A, C, W and Y polysaccharides at 10 micrograms each per 0.5 ml doses.2
  • All four are conjugated to tetanus toxoid carrier protein, 55 microgramss.2
  • No aluminium adjuvant is listeds.2
  • Excipients: sodium chloride, sodium acetate (E262), water for injectionss.6.1
  • Declared essentially sodium-free, less than 1 mmol (23 mg) per doses.4.4
  • The vaccine does not substitute for routine tetanus immunisation, even though it contains tetanus toxoid as a carriers.4.4

Manufacture, storage and handling

  • Shelf life 4 yearss.6.3
  • Store at 2C to 8C, do not freezes.6.4
  • Stable at temperatures up to 25C for 72 hours, but these data are intended to guide professionals in case of a temporary temperature excursion only; use or discard at the end of the periods.6.4
  • Intramuscular injection only, preferably the deltoid or the anterolateral thigh depending on age and muscle masss.4.2
  • Must not be administered subcutaneously, intravascularly or intradermallys.4.4
  • Discard if particulate matter, discolouration or any variation in appearance is seens.6.6
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2
  • A single 0.5 ml dose for primary vaccination from 12 months; a single dose may also be used to boost people who previously received a meningococcal vaccine containing the same serogroupss.4.2

Safety findings

  • The safety and immunogenicity of MenQuadfi in individuals under 12 months of age have not yet been establisheds.4.2
  • There are no data available to indicate the need for, or timing of, a booster doses.4.2
  • The only listed contraindication is hypersensitivity to the active substances, the excipients, or after a previous dose of the vaccine or a vaccine containing the same componentss.4.3
  • Vaccination should be postponed during acute severe febrile illness; a minor infection such as a cold is not a reason to defers.4.4
  • The vaccine will only protect against Neisseria meningitidis groups A, C, W and Y and will not protect against any other groupss.4.4
  • As with any vaccine, it may not protect all recipientss.4.4
  • Waning of serum bactericidal antibody titres against serogroup A has been reported for MenQuadfi and other quadrivalent meningococcal vaccines, and 'the clinical relevance of this observation is unknown'. If someone is expected to be at particular risk of exposure to serogroup A and received a dose more than about a year earlier, consideration may be given to a boosters.4.4
  • Lower antibody responses against serogroup A have been observed after a single dose in toddlers who previously received a group C meningococcal conjugate vaccine in infancy, though seroprotection rates were comparable; the clinical relevance is unknown and this might be considered for children at high risk of group A infection who had that infant vaccines.4.4
  • Persons with familial complement deficiencies such as C5 or C3 deficiency, and those receiving treatments that inhibit terminal complement activation such as eculizumab, remain at increased risk of invasive disease from groups A, C, W and Y even if they develop antibodies after vaccination. 'No data on immunocompromised patients are available's.4.4
  • It may be expected that patients receiving immunosuppressive treatment or with immunodeficiency may not mount an adequate immune responses.4.4, 4.5
  • Fainting and other anxiety-related reactions can occur after or even before any vaccination as a response to the needle, so procedures should be in place to prevent falling or injurys.4.4
  • When given with the 13-valent pneumococcal vaccine, lower antibody titres against serogroup A were observed at day 30; the clinical relevance is unknown, and as a precaution in children 12 to 23 months at high risk of group A disease, consideration might be given to giving the two vaccines separatelys.4.5
  • When given with Tdap-IPV and the 9-valent HPV vaccine in 10 to 17 year olds, there were lower antibody titres and seroresponse rates for serogroup A, lower titres for serogroup W, and lower responses to inactivated polio types 1 and 3, diphtheria and anti-HPV types 6 and 58. 'The clinical implication of the observed reduced titre responses is unclear', and sequential administration might be considered for those at higher risks.4.5
  • When Tdap and the 4-valent HPV vaccine were given with MenQuadfi, responses to pertussis antigens FHA, PRN and FIM were lower than with the HPV vaccine alone; the clinical implications are unknown and the same has been seen with other quadrivalent meningococcal conjugate vacciness.4.5
  • Injection sites on separate limbs and separate syringes must be used for concomitant administration, and concomitant vaccines should preferably be given contralaterallys.4.5
  • Concomitant administration with vaccines other than those listed has not been studieds.4.5
  • In toddlers 12 to 23 months, very common reactions were irritability (36.7 per cent), injection site tenderness (30.6 per cent), appetite lost, drowsiness, abnormal crying, and injection site redness and swelling; common reactions were fever, vomiting and diarrhoeas.4.8
  • Rates of adverse reactions in toddlers were higher when the 13-valent pneumococcal vaccine was given with MenQuadfi (36.5 per cent) than with the pneumococcal vaccine alone (17.2 per cent)s.4.8
  • In ages 2 and over, very common reactions were injection site pain (38.7 per cent), myalgia (30.5 per cent), headache and malaises.4.8
  • Injection site pain at the HPV injection site was higher when it was given with Tdap-IPV and MenQuadfi (83.6 per cent) than without MenQuadfi (67.3 per cent)s.4.8
  • Systemic reactions tended to be higher when MenQuadfi was given with a MenB vaccine: myalgia in 65.2 per cent and 63 per cent against 32.8 per cent for MenQuadfi alones.4.8
  • Post-marketing reports at frequency not known include hypersensitivity, febrile convulsions and seizuress.4.8
  • Anaphylaxis is listed as very rare; lymphadenopathy, urticaria, pruritus, rash, diarrhoea, stomach pain, pain in extremity, chills, axillary pain and injection site induration are listed as rares.4.8
  • In older adults aged 56 and over the same reactions were seen as in younger adults but at lower frequencies, except injection site pruritus which was more frequents.4.8
  • Pregnancy: there is a limited amount of data on use in pregnant women, and the vaccine should be used only if the expected benefits for the mother outweigh the potential risks, including those for the foetuss.4.6
  • Breastfeeding: it is unknown whether MenQuadfi is excreted in human milk, and it should only be used when the possible advantages outweigh the potential riskss.4.6
  • Fertility: a developmental and reproductive toxicity study in female rabbits showed no effects on mating performance or female fertility, but no study was conducted on male fertilitys.4.6
  • Overdose is unlikely because of the single dose vial presentation; monitoring of vital functions and symptomatic treatment is recommendeds.4.9

Evidence and claims

  • Immunogenicity was assessed in six pivotal trials plus two additional trials for primary vaccination, and one pivotal trial plus four additional trials for booster vaccination, in toddlers 12 to 23 months, children and adolescents 2 to 17 years, adults 18 to 55 and older adults 56 and overs.5.1
  • Antibody persistence data are available from at least 3 years and up to 7 years after primary vaccinations.5.1
  • The main measure is serum bactericidal activity using human complement, a laboratory test of whether antibodies kill the bacterium; rabbit complement results are also available and generally follow the same trendss.5.1
  • In vaccine-naive toddlers, seroprotection 30 days after MenQuadfi was 90.8 per cent for serogroup A, 99.3 per cent for C, 83.6 per cent for W and 93.2 per cent for Ys.5.1
  • The lowest response is against serogroup W, where seroprotection was 83.6 per cent and seroresponse 67.6 per cent in vaccine-naive toddlers, similar to the comparator vaccines.5.1
  • Antibody geometric mean titres differ widely by serogroup, from 22.0 against W to 436 against C in vaccine-naive toddlerss.5.1
  • The safety database is 6,308 subjects who received either a primary dose (5,906) or a booster dose (402), across all age groups from 12 monthss.4.8
  • Preclinical data revealed no special risks for humans based on a developmental and reproductive toxicity study in female rabbits; a full human dose showed no effects on mating performance, female fertility, no teratogenic potential, and no effect on pre- or post-natal developments.5.3

Document and licensing

  • Marketing authorisation holder: Aventis Pharma Limited, Reading, trading as Sanofis.7
  • First authorised 18 November 2020, CAP conversion 1 January 2021, latest renewal 26 June 2025s.9
  • Text last revised 15 January 2026s.10
  • The label states plainly that no data exist on immunocompromised patients, and sets out the co-administration findings with the exact antibody responses affecteds.4.4, 4.5
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

One dose (0.5 mL) contains: 
 Neisseria meningitidis group A polysaccharide^1
 Neisseria meningitidis group C polysaccharide^1
 Neisseria meningitidis group W polysaccharide^1
 Neisseria meningitidis group Y polysaccharide^1
 ^1Conjugated to tetanus toxoid carrier protein
 10 micrograms ^ 
 10 micrograms ^ 
 10 micrograms ^ 
 10 micrograms ^ 
 55 micrograms ^ 
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • neisseria meningitidis - The bacterium that causes meningococcal disease. The vaccine uses purified proteins from it, not the live bacterium.
  • tetanus toxoid - A tetanus toxin that has been treated so it can no longer cause disease but still trains the immune system.

Other ingredients (excipients)

Section 6.1 source ↗

  • Sodium chlorideSalt. Used to keep the liquid at the same saltiness as the body.
  • Sodium acetate (E 262)A buffer (E262), used to hold the liquid at a steady acidity.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
Audit trail: every flagged sentence in the document (35)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. • There are no data available to indicate the need for or timing of a booster dose of MenQuadfi (see section 5.1).

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

4.4 Special warnings and precautions for use

  1. The clinical relevance of this observation is unknown.

    Section 4.4 Special warnings and precautions for use source ↗

    No data / not studied matched: is unknown

  2. Lower hSBA geometric mean titres (GMTs) against serogroup A have been observed after a single dose of MenQuadfi was administered to toddlers who previously received serogroup C meningococcal conjugate vaccine (MenC-CRM) during infancy.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • geometric mean - An average used for antibody levels, because those vary over a huge range.
    • conjugate - A design where a sugar from a germ is attached to a carrier protein, so the immune system responds properly.

    Efficacy, effectiveness and endpoints matched: geometric mean

  3. The clinical relevance of this observation is unknown.

    Section 4.4 Special warnings and precautions for use source ↗

    No data / not studied matched: is unknown

  4. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited (see section 4.5).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunosuppressive - A medicine or treatment that dampens the immune system.

    Efficacy, effectiveness and endpoints matched: immune response

  5. No data on immunocompromised patients are available.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    Immune system, shedding and transmissionNo data / not studied matched: immunocompromised, no data

4.5 Interaction with other medicinal products and other forms of interaction

  1. There was no impact on the immune response to MenQuadfi when a meningococcal serogroup B vaccine was co-administered.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  2. The clinical relevance of this observation is unknown.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    No data / not studied matched: is unknown

  3. For ages 10-17 years, MenQuadfi can be co-administered with diphtheria, tetanus, pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) (Tdap), or Tdap and inactivated poliovirus vaccine (Tdap-IPV), and 4-valent human papillomavirus vaccine (recombinant, adsorbed) (4vHPV) or 9-valent HPV vaccine (9vHPV).

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • inactivated - Killed. The organism cannot replicate at all.
    • recombinant - Made by genetic engineering: the gene for one piece of a germ is put into a lab cell or bacterium, which then makes that piece.
    • antigen - The part of a germ that the immune system recognises and remembers.

    Genetic engineering, vectors and GMOs matched: recombinant

  4. Meningococcal vaccine naïve children and adolescents aged 10-17 years had non inferior response for PT and lower antibody responses to FHA, PRN and FIM when Tdap vaccine was administered concomitantly with MenQuadfi and 4vHPV compared to co-administration with 4vHPV vaccine alone (immune response assessed after the full series of HPV was completed).

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  5. The clinical implications of the observed pertussis antigen responses also observed with other quadrivalent meningococcal conjugate vaccines are unknown.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • conjugate - A design where a sugar from a germ is attached to a carrier protein, so the immune system responds properly.
    • antigen - The part of a germ that the immune system recognises and remembers.

    No data / not studied matched: are unknown

  6. The co-administration of MenQuadfi with Tdap-IPV and 9vHPV in children and adolescents aged 10-17 years resulted in lower GMTs and seroresponse rates for serogroup A, lower GMTs for serogroup W, lower responses to inactivated polio types 1 and 3, diphtheria, and anti-HPV types 6 and 58 (immune response assessed after the first dose of 9vHPV) compared to when MenQuadfi was given sequentially with [...]

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • inactivated - Killed. The organism cannot replicate at all.

    Efficacy, effectiveness and endpoints matched: immune response

  7. Concomitant administration of MenQuadfi and other vaccines than those listed above has not been studied.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.

    No data / not studied matched: has not been studied

  8. It may be expected that in patients receiving immunosuppressive treatment an adequate immune response may not be elicited (see also section 4.4).

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • immunosuppressive - A medicine or treatment that dampens the immune system.

    Efficacy, effectiveness and endpoints matched: immune response

4.6 Fertility, pregnancy and lactation

  1. It is unknown whether MenQuadfi is excreted in human milk.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    No data / not studied matched: is unknown

4.8 Undesirable effects

  1. Adolescents and adults 13-26 years of age primed with MenQuadfi 3-6 years previously received MenQuadfi co-administered with meningococcal serogroup B vaccine (MenB), MenB (recombinant, adsorbed) (N = 93) or MenB (rDNA, component, adsorbed) (N = 92).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • recombinant - Made by genetic engineering: the gene for one piece of a germ is put into a lab cell or bacterium, which then makes that piece.

    Genetic engineering, vectors and GMOs matched: recombinant

  2. The most common solicited systemic adverse reaction was myalgia, of mild intensity, which was experienced more frequently in adolescents and adults who received MenQuadfi and MenB vaccine concomitantly (MenB [recombinant, adsorbed], 65.2%; or MenB [rDNA, component, adsorbed], 63%) compared to those who received MenQuadfi alone (32.8%).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • recombinant - Made by genetic engineering: the gene for one piece of a germ is put into a lab cell or bacterium, which then makes that piece.
    • myalgia - Muscle aches.
    • common - In the label's frequency scale, this means it happened in up to 1 in 10 people studied.

    Genetic engineering, vectors and GMOs matched: recombinant

  3. Not known (cannot be estimated from the available data).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

5.1 Pharmacodynamic properties

  1. Primary immunogenicity analyses were conducted by measuring serum bactericidal activity (SBA) using human serum as the source of exogenous complement (hSBA).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • immunogenicity - How strongly the vaccine provokes an immune response. It is measured in the blood, not by how many people avoided the illness.

    Animal, human or cell-line derived material matched: human serum

  2. The clinical relevance of these results is unknown.

    Section 5.1 Pharmacodynamic properties source ↗

    No data / not studied matched: is unknown

  3. There were differences in the hSBA GMTs for serogroup A when MenQuadfi was co-administered with PCV-13 (N = 196) compared with MenQuadfi administered alone (N = 96) (24.6 [95%CI 20.2; 30.1] and 49.0 [95%CI 36.8; 65.3]).) The clinical relevance of these results is unknown but this observation might be taken into consideration for individuals at high risk for MenA infection and consequently [...]

    Section 5.1 Pharmacodynamic properties source ↗

    No data / not studied matched: is unknown

  4. In an exploratory analysis in a non-random subset of participants (N = 60), the immune response and protection rates were measured 6 and 30 days following co-administration of MenQuadfi with Tdap-IPV and 9vHPV.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  5. Persistence of immune response and MenQuadfi booster response

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  6. Persistence of immune response and MenQuadfi booster response in children 4 through 5 years of age

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  7. The antibody persistence prior to the MenQuadfi booster dose and the booster immune response were assessed according to the vaccine (MenQuadfi or MenACWY-TT) children had received 3 years ago (see Table 11).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  8. The 3Y post-primary (D0 pre-booster) GMTs were higher than the pre-primary GMTs, indicative of long-term persistence of immune response.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  9. Persistence of immune response and MenQuadfi booster response in children 6 through 7 years of age

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  10. For all serogroups, the 5Y post-primary (pre-booster) GMTs were higher than the pre-primary GMTs, indicative of persistence of immune response.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  11. Persistence of immune response and MenQuadfi booster response in adolescents and adults 13 through 26 years of age

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  12. The antibody persistence prior to the MenQuadfi booster dose and the booster immune response were assessed according to the vaccine (MenQuadfi or MenACWY-CRM) subjects had received 3-6 years previously (see Table 13).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  13. The 3-6Y post-primary dose (D0 pre-booster) GMTs were higher than the pre-primary GMTs, indicative of long-term persistence of immune response.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  14. Persistence of immune response and MenQuadfi booster response in adults 59 years of age and older

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  15. The antibody persistence prior to the MenQuadfi booster dose and the booster immune response were assessed according to the vaccine (MenQuadfi or MenACWY-PS) subjects had received 3 years previously in MET49 (Table 14).

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  16. In addition, for both primed groups, the 3 Year (3Y) post-primary dose (pre-booster) GMTs were higher than the pre-primary GMTs for serogroups C, W and Y (indicative of long-term persistence of immune response for these serogroups) and were comparable for serogroup A.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  17. The 6-7Y post-primary GMTs were higher than the pre-primary GMTs for serogroup C, W, and Y in MenQuadfi-primed adults, indicative of long-term persistence of immune response for these serogroups, and were comparable for serogroup A.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

Read the whole document at the source ↗