MenQuadfi

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ANNEX I  
 

SUMMARY OF PRODUCT CHARACTERISTICS  



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This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See 
section 4.8 for how to report adverse reactions. 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MenQuadfi solution for injection 
Meningococcal Group A, C, W and Y conjugate vaccine  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One dose (0.5 mL) contains:  
Neisseria meningitidis group A polysaccharide1  10 micrograms 
Neisseria meningitidis group C polysaccharide1  10 micrograms 
Neisseria meningitidis group Y polysaccharide1  10 micrograms 
Neisseria meningitidis group W polysaccharide1  10 micrograms 
 
1Conjugated to tetanus toxoid carrier protein  55 micrograms 
 
For the full list of excipients, see section 6.1.  
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
Clear colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications  
 
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. 
 
4.2 Posology and method of administration  
 
Posology 
 
Primary vaccination: 
• Individuals 12 months of age and older: One single dose (0.5 mL). 
Booster vaccination: 
• A single 0.5 mL dose of MenQuadfi may be used to boost subjects who have previously received a 

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

section 5.1). 
 



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Other paediatric population 
The safety and immunogenicity of MenQuadfi in individuals under 12 months of age have not yet been 
established.  
 
Method of administration 
For intramuscular injection only, preferably in the deltoid region or anterolateral thigh depending on the 
recipient's age and muscle mass. 
 
For instructions on handling of the vaccine before administration, see section 6.6. 
 
4.3 Contraindications  
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or after previous 
administration of the vaccine or a vaccine containing the same components. 
 
4.4 Special warnings and precautions for use  
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number of 
the administered product should be clearly recorded. 
 
MenQuadfi should not be administered subcutaneously, intravascularly or intradermally. 
 
It is good clinical practice to precede vaccination by a review of the medical history (especially with 
regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination. 
 
Hypersensitivity 
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily 
available in case of an anaphylactic event following administration of the vaccine. 
 
Intercurrent illness 
Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, 
the presence of a minor infection, such as cold, should not result in the deferral of vaccination. 
 
Syncope 
Syncope (fainting) and other anxiety‐related reactions can occur following or even before any 
vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent 
falling or injury and to manage syncope.  
 
Thrombocytopenia and coagulation disorders 
MenQuadfi should be given with caution to individuals with thrombocytopenia or any coagulation 
disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs 
the risk of administration. 
 
Protection 
MenQuadfi will only protect against Neisseria meningitidis groups A, C, W, and Y. The vaccine will not 
protect against any other Neisseria meningitidis groups.  
 
As with any vaccine, vaccination with MenQuadfi may not protect all vaccine recipients. 
 



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Waning of serum bactericidal antibody titres against serogroup A when using human complement in the 
assay (hSBA) has been reported for other quadrivalent meningococcal vaccines. The clinical relevance of 
this observation is unknown. No data are available for MenQuadfi. 
 
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. Nevertheless, seroprotection rates were comparable 
between treatment groups (see section 5.1). The clinical relevance of this observation is unknown. This 
aspect might be considered for individuals at high risk for MenA infection who received MenC-CRM 
vaccine in their first year of life.  
 
Immunodeficiency 
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). Persons with 
familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments 
that inhibit terminal complement activation (for example, eculizumab) are at increased risk of invasive 
disease caused by Neisseria meningitidis groups A, C, W, and Y, even if they develop antibodies 
following vaccination with MenQuadfi. No data on immunocompromised patients are available. 

Tetanus immunisation 
Immunisation with MenQuadfi vaccine does not substitute for routine tetanus immunisation. 
Co-administration of MenQuadfi with a tetanus toxoid-containing vaccine does not impair the response to 
tetanus toxoid or impact the safety. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Use with other vaccines 
Injection sites on separate limbs and separate syringes must be used in the case of concomitant 
administration. 
 
For ages 12-23 months, MenQuadfi can be co-administered with the measles-mumps-rubella vaccine 
(MMR) and varicella vaccine (V), combined diphtheria - tetanus - acellular pertussis (DTaP) vaccines, 
including combination DTaP vaccines with hepatitis B (HBV), inactivated poliovirus (IPV) or 
Haemophilus influenzae type b (Hib) such as DTaP-IPV-HB-Hib (Hib conjugated to tetanus toxoid) 
vaccine and 13-valent pneumococcal polysaccharide conjugated vaccine (PCV-13). 
 
For ages 10-17 years, MenQuadfi can be co-administered with diphtheria, tetanus, pertussis (acellular, 
component) vaccine (adsorbed, reduced antigen(s) content) (Tdap) and human papillomavirus vaccine 
(recombinant, adsorbed) (HPV). 
 
MenQuadfi can be administered concomitantly with PCV-13. Lower hSBA GMTs on day 30 post-dose 
for serogroup A has been observed when given concommitantly. The clinical relevance of this 
observation is unknown. As a precaution in children 12-23 months of age at high risk for serogroup A 
disease, consideration might be given for administration of MenQuadfi and PCV-13 vaccines separately. 
 
Meningococcal vaccine naïve children 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 HPV compared to co-administration with HPV vaccine alone. The clinical implications 



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of the observed pertussis antigen responses also observed with the existing quadrivalent meningococcal 
conjugate vaccines are unknown. 
 
Concomitant vaccines should always be administered at separate injection sites and preferably 
contralateral.  
 
Concomitant administration of MenQuadfi and other vaccines than those listed above has not been 
studied. 
 
Use with systemic immunosuppressive medicinal products 
It may be expected that in patients receiving immunosuppressive treatment an adequate immune response 
may not be elicited (see also section 4.4). 
 
4.6 Fertility, pregnancy and lactation  
 
Pregnancy 
There is limited amount of data on the use of MenQuadfi in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
MenQuadfi should be used during pregnancy only if the expected benefits for the mother outweigh the 
potential risks, including those for the foetus. 
 
Breast-feeding 
It is unknown whether MenQuadfi is excreted in human milk. MenQuadfi should only be used during 
breast-feeding when the possible advantages outweigh the potential risks. 
 
Fertility 
A developmental and reproductive toxicity study was performed in female rabbits. There were no effects 
on mating performances or female fertility. No study was conducted on male fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines  
 
MenQuadfi has no or negligible influence on the ability to drive and use machines. 
However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect 
the ability to drive or use machines. 
 
4.8 Undesirable effects  
 
Summary of the safety profile 
The safety of a single dose of MenQuadfi in individuals 12 months of age and older was evaluated in 
seven randomized, active-controlled, multi-centre pivotal studies.  In these studies, 6,308 subjects 
received either a primary dose (N=5,906) or a booster dose (N=402) of MenQuadfi and were included in 
the safety analyses. This included 1,389 toddlers aged 12 through 23 months of age, 498 children aged 2 
through 9 years, 2,289 adolescents aged 10 through 17 years, 1,684 adults aged 18 through 55 years, 
199 older adults aged 56 through 64 years, and 249 elderly aged 65 years and older. Of these, 
392 adolescents received MenQuadfi co-administered with Tdap and HPV, and 589 toddlers received 
MenQuadfi co-administered with MMR+V (N=189), DTaP-IPV-HB-Hib (N=200) or PCV-13 (N=200). 
 
The most frequently reported adverse reactions within 7 days after vaccination with a single dose of 
MenQuadfi alone in toddlers 12 through 23 months of age were irritability (36.7%) and injection site 



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tenderness (30.6%) and in ages 2 years and above were injection site pain (38.7%) and myalgia (30.5%). 
These adverse reactions were mostly mild or moderate in intensity. 
Rates of adverse reactions after a booster dose of MenQuadfi in adolescents and adults at least 15 years of 
age were comparable to those seen in adolescents and adults who received a primary dose of MenQuadfi.  
 
Rates of adverse reactions within 7 days following vaccination among toddlers were comparable when 
MMR+V were given concomitantly with or without MenQuadfi, and when DTaP-IPV-HB-Hib was given 
with or without MenQuadfi. Overall, the rates of adverse reactions were higher in toddlers who received 
PCV-13 given concomitantly with MenQuadfi (36.5%) than in toddlers who received PCV-13 alone 
(17.2%). 
 
Tabulated list of adverse reactions 
The following adverse reactions, as listed below, have been identified from clinical studies conducted 
with MenQuadfi when given alone to subjects 2 years of age and older. The safety profile observed in 
toddlers aged 12 through 23 months is presented in the paediatric population section. 
The adverse reactions are listed according to the following frequency categories: 
Very common (≥1/10); 
Common (≥1/100 to <1/10);  
Uncommon (≥1/1,000 to <1/100);  
Rare (≥1/10,000 to <1/1,000).  
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Table 1: Tabulated summary of adverse reactions following administration of MenQuadfi from 
clinical trials in subjects 2 years of age and above 
 

MedDRA System Organ Class Frequency Adverse reactions 
Blood and lymphatic system 
disorders 

Rare Lymphadenopathy 

Nervous system disorders Very common Headache 
Uncommon Dizziness 

Gastrointestinal disorders Uncommon Vomiting, nausea 
Rare Diarrhoea, stomach pain 

Skin and subcutaneous tissue 
disorders 

Rare Urticaria, pruritus, rash 

Musculoskeletal and connective 
tissue disorders 

Very common Myalgia 
Rare Pain in extremity 

General disorders and 
administration site conditions 

Very common Malaise 
Injection site pain 

Common Fever 
At the injection site:  swelling, erythema 

Uncommon Fatigue 
At the injection site: pruritus, warmth, bruising, rash 

Rare Chills, axillary pain 
At the injection site: induration 

 
Paediatric population 
The safety profile of MenQuadfi in children and adolescents 2 through 17 years of age was generally 
comparable to that in adults. Injection site erythema and swelling at the MenQuadfi injection site were 



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reported more frequently in children 2 through 9 years of age (very common) than in the older age 
groups. 
 
In toddlers 12 through 23 months of age, injection site erythema and swelling (very common) at the 
MenQuadfi injection site, vomiting (common) and diarrhoea (common), were reported more frequently 
than in the older age groups. The following additional reactions, as listed below in Table 2, have been 
reported very commonly or commonly following administration of MenQuadfi in toddlers during clinical 
trials:  
 
Table 2: Tabulated summary of adverse reactions following administration of MenQuadfi from 
clinical trials in subjects 12 months through 23 months 
 

MedDRA System Organ Class Frequency Adverse reactions 
Metabolic and nutrition disorders Very common Appetite lost 
Psychiatric disorders Very common Irritability 

Uncommon Insomnia 
Nervous system disorders Very common Drowsiness 
Gastrointestinal disorders Common Vomiting, diarrhoea 
Skin and subcutaneous tissue 
disorders 

Uncommon Urticaria 

General disorders and 
administration site conditions 

Very Common Abnormal crying 
At the injection site: tenderness/pain, erythema, 
swelling 

Common Fever 
Uncommon At the injection site: pruritus, induration, bruising, 

rash 
 
Older population 
Overall, within 7 days after vaccination with a single dose of MenQuadfi, the same injection site and 
systemic adverse reactions were observed in older (≥56 years of age) and younger adults (18 through 
55 years old) but at lower frequencies; except for injection site pruritus, which was more frequent 
(common) in older adults. These adverse reactions mostly were mild or moderate in intensity. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are 
asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose  
 
Overdose with MenQuadfi is unlikely due to its presentation as a single dose vial. In the event of 
overdose, monitoring of vital functions and possible symptomatic treatment is recommended.. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties  
 
Pharmacotherapeutic group: meningococcal vaccines 
 
ATC code: J07AH08  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Mechanism of action 
Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement 
mediated bactericidal activity.  
MenQuadfi induces the production of bactericidal antibodies specific to the capsular polysaccharides of 
Neisseria meningitidis serogroups A, C, W, and Y. 
 
Immunogenicity 
The immunogenicity of a single dose of MenQuadfi for primary vaccination in toddlers (12-23 months of 
age), children and adolescents (2-17 years of age), adults (18-55 years of age) and older adults (56 years 
and above) was assessed in six pivotal studies. The immunogenicity of a single dose of MenQuadfi for 
booster vaccination (subjects 15 to 55 years of age) was assessed in one pivotal study.   
 
Primary immunogenicity analyses were conducted by measuring serum bactericidal activity (SBA) using 
human serum as the source of exogenous complement (hSBA). Rabbit complement (rSBA) data are 
available in subsets in all age groups and generally follows the trends observed with human complement 
(hSBA) data. 
 
Clinical data are not yet available on the persistence of antibody responses following primary vaccination 
with MenQuadfi nor for booster vaccination in individuals primed with MenQuadfi. 
 
Toddlers 12 to 23 month of age 
Immunogenicity in subjects 12 through 23 months of age was evaluated in two clinical studies (MET51 
[NCT02955797] and MET57 [NCT03205371]). 
 
MET51 was conducted in subjects who were either meningococcal vaccine naïve or had been primed with 
monovalent meningococcal C conjugate vaccines in their first year of life (see table 3). 
MET57 was conducted in meningococcal vaccine naïve toddlers to assess the immunogenicity and safety 
of the concomitant administration of MenQuadfi with paediatric vaccines (MMR+V, DTaP-IPV-HB-Hib 
or PCV-13). 
 
Table 3: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-TT vaccine 
30 days after vaccination of meningococcal vaccine naïve subjects only or combined (naïve + MenC 
primed) subjects 12 through 23 months of age (study MET51*) 
 

Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

Naïve  

MenACWY-TT  
(95% CI) 

Naïve  

MenQuadfi 
(95% CI) 

Combined (Naïve 
+ MenC Primed)  

MenACWY-TT  
(95% CI) 

Combined (Naïve 
+ MenC Primed) 

A N=293 N=295 N=490 N=393-394 
% ≥1:8 
(Seroprotection)** 

90.8 
(86.9; 93.8) 

89.5 
(85.4; 92.7) 

90.4 
(87.4; 92.9) 

91.6 
(88.4; 94.2) 

% Seroresponse 76.8 
(71.5; 81.5) 

72.5 
(67.1; 77.6) 

76.5 
(72.5; 80.2) 

77.1 
(72.6; 81.2) 

hSBA GMT 28.7  
(25.2; 32.6) 

28.0  
(24.4; 32.1)  

29.9 
(26.9; 33.2) 

34.5 
(30.5; 39.0) 

C N=293 N=295 N=489 N=393-394 
% ≥1:8 
(Seroprotection)** 

99.3 
 (97.6; 99.9) 

81.4 
(76.4; 85.6) 

99.2 
(97.9; 99.8) 

85.5 
(81.7; 88.9) 



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Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

Naïve  

MenACWY-TT  
(95% CI) 

Naïve  

MenQuadfi 
(95% CI) 

Combined (Naïve 
+ MenC Primed)  

MenACWY-TT  
(95% CI) 

Combined (Naïve 
+ MenC Primed) 

% Seroresponse 98.3 
(96.1; 99.4) 

71.5 
(66.0; 76.6) 

97.1 
(95.2; 98.4) 

77.4 
(72.9; 81.4) 

hSBA GMT 436 
(380; 500) 

26.4  
(22.5; 31.0) 

880 
(748; 1035) 

77.1 
(60.7; 98.0) 

W N=293 N=296 N=489 N=393-394 
% ≥1:8 
(Seroprotection)** 

83.6 
(78.9; 87.7) 

83.4 
 (78.7; 87.5) 

84.9 
(81.4; 87.9) 

84.0 
(80.0; 87.5) 

% Seroresponse 67.6  
(61.9; 72.9) 

66.6  
(60.9; 71.9) 

70.8 
(66.5; 74.8) 

68.4 
(63.6; 73.0) 

hSBA GMT 22.0 
(18.9; 25.5) 

16.4 
(14.4; 18.6) 

24.4 
(21.8; 27.5) 

17.7 
(15.8; 19.8) 

Y N=293 N=296 N=488-490 N=394-395 
% ≥1:8 
(Seroprotection)** 

93.2 
(89.7; 95.8) 

91.6 
(87.8; 94.5) 

94.3 
(91.8; 96.2) 

91.6 
(88.5; 94.2) 

% Seroresponse 81.9 
(77.0; 86.1) 

79.1  
(74.0; 83.5) 

84.8 
(81.3; 87.9) 

78.9 
(74.6; 82.9) 

hSBA GMT 38.0 
(33.0; 43.9) 

32.2 
(28.0; 37.0) 

41.7 
(37.5; 46.5) 

31.9 
(28.4; 36.0) 

* Clinical trial identifier NCT02955797  
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met 

 
Response in subjects previously vaccinated with MenC conjugate vaccines in their first year of life: 
The majority of monovalent meningococcal C conjugate vaccine primed toddlers (12-23 months of age) 
in study MET51 (NCT02955797) had hSBA titres ≥1:8 in the MenQuadfi group (N=198) (≥ 86.7%) and 
in MenACWY-TT group (N=99) (≥ 85.7%) at D30 post-vaccination. These toddlers received during their 
infancy MenC-TT or MenC-CRM vaccines. Post-vaccination seroprotection rates were comparable 
between MenQuadfi and MenACWY-TT for all serogroups regardless of the priming background.  
 
In MenC-CRM primed subjects the GMTs for serogroup A were lower in the MenQuadfi group (n=49) 
than in the MenACWY-TT group (n=25) [12.0 (8.23; 17.5) vs 42.2 (25.9; 68.8)]. After administration of 
Menquadfi seroprotection rates (hSBA titres ≥1:8) for subjects primed with MenC-CRM were lower but 
still comparable for serogroups A, Y and W compared with those in the MenACWY-TT group [A: 68% 
(53.7; 81.3) vs 96.0% (79.6; 99.9)]; Y: 68.1% (52.9; 80.9) vs 80.0% (59.3; 93.2); W: 68.1% (52.9; 80.9) 
vs 79.2% (57.8; 92.9)]. The rates for serogroup C were comparable in both groups [95.8% (85.7; 99.5) vs 
92.0% (74.0; 99.0)]. The clinical relevance of these results is unknown. This aspect might/ be considered 
for individuals at high risk for MenA infection who received MenC-CRM vaccine in their first year of 
life. 
 
MET57 (NCT03205371) was conducted in meningococcal vaccine naïve toddlers 12 through 23 months 
of age to assess the immunogenicity and safety of the concomitant administration of MenQuadfi with 
paediatric vaccines (MMR+V, DTaP-IPV-HB-Hib or PCV-13). Overall, the post-vaccination hSBA 
seroprotection rates in subjects who received MenQuadfi was high for all serogroups (between 88.9% and 



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100%). Seroresponse and seroprotection rates for serogroup A were comparable when MenQuadfi was 
co-administered with PCV-13 and alone (56.1%, [95% CI 48.9; 63.2] and 83.7% [95% CI 77.7; 88.6] vs 
71.9% [95%CI 61.8; 80.6] and 90.6% [95%CI 82.9; 95.6]). 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 are unknown but this observation might be taken into consideration for 
individuals at high risk for MenA infection and consequently vaccinations with MenQuadfi and PCV13 
might be performed separately. 
 
Children 2 through 9 years of age 
Immunogenicity in subjects 2 through 9 years of age was evaluated in study MET35 (NCT03077438) 
(stratified by ages 2 through 5 and 6 through 9 years) comparing seroresponses following administration 
of either MenQuadfi or MenACWY-CRM. 
 
Overall, for subjects 2 through 9 years of age, immune non-inferiority, based on hSBA seroresponse, was 
demonstrated for MenQuadfi as compared to MenACWY-CRM for all four serogroups. 
 
Table 4: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-CRM 
30 days after vaccination in meningococcal vaccine naïve subjects 2 through 5 years and 6 through 
9 years of age (study MET35*) 
 

2-5 years 6-9 years 
Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

MenACWY-CRM 
(95% CI) 

MenQuadfi 
(95% CI) 

MenACWY-CRM 
(95% CI) 

A N=227-228 N=221 N=228 N=237 
% ≥1:8 
(Seroprotection) 

84.6 
(79.3; 89.1) 

76.5 
(70.3; 81.9) 

88.2 
(83.2; 92.0) 

81.9 
(76.3; 86.5) 

% Seroresponse 52.4  
(45.7; 59.1) 

44.8  
(38.1; 51.6) 

58.3 
(51.6; 64.8) 

50.6  
(44.1; 57.2) 

hSBA GMT 21.6  
(18.2; 25.5) 

18.9  
(15.5; 23.0) 

28.4  
(23.9; 33.8) 

26.8  
(22.0; 32.6) 

C N=229 N=222-223 N=229 N=236 
% ≥1:8 
(Seroprotection) 

97.4  
(94.4; 99.0) 

64.6 
(57.9; 70.8) 

98.3 
(95.6; 99.5) 

69.5 
(63.2; 75.3) 

% Seroresponse 94.3 
(90.5; 96.9) 

43.2 
(36.6; 50.0) 

96.1 
(92.7; 98.2) 

52.1 
(45.5; 58.6) 

hSBA GMT 208 
(175; 246) 

11.9 
(9.79; 14.6) 

272 
(224; 330) 

23.7 
(18.2; 31.0) 

W N=229 N=222 N=229 N=237 
% ≥1:8 
(Seroprotection) 

90.8 
(86.3; 94.2) 

80.6 
(74.8; 85.6) 

98.7 
(96.2; 99.7) 

91.6 
(87.3; 94.8) 

% Seroresponse 73.8 
(67.6; 79.4) 

61.3 
(54.5; 67.7) 

83.8 
(78.4; 88.4) 

66.7 
(60.3; 72.6) 

hSBA GMT 28.8 
(24.6; 33.7) 

20.1 
(16.7; 24.2) 

48.9 
(42.5; 56.3) 

33.6 
(28.2; 40.1) 

Y N=229 N=222 N=229 N=237 



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2-5 years 6-9 years 
Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

MenACWY-CRM 
(95% CI) 

MenQuadfi 
(95% CI) 

MenACWY-CRM 
(95% CI) 

% ≥1:8 
(Seroprotection) 

97.8 
(95.0; 99.3) 

86.9 
(81.8; 91.1) 

99.1 
(96.9; 99.9) 

94.5 
(90.8; 97.0) 

% Seroresponse 88.2 
(83.3; 92.1) 

77.0 
(70.9; 82.4) 

94.8 
(91.0; 97.3) 

81.4 
(75.9; 86.2) 

hSBA GMT 49.8 
(43.0; 57.6) 

36.1 
(29.2; 44.7) 

95.1 
(80.2; 113) 

51.8 
(42.5; 63.2) 

* Clinical trial identifier NCT03077438 
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 
 
Children and adolescents 10 through 17 years of age 
Immunogenicity in subjects aged 10 through 17 years of age was evaluated in two studies comparing 
seroresponses following administration of MenQuadfi compared to either MenACWY-CRM (MET50 
[NCT02199691]) or MenACWY-DT (MET43[NCT02842853]). 
 
MET50 was conducted in meningococcal vaccine naïve subjects and seroresponse was evaluated 
following administration with either MenQuadfi alone, MenACWY-CRM alone, MenQuadfi co-
administered with Tdap and HPV or Tdap and HPV alone. 
 
Table 5: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-CRM 
30 days after vaccination in meningococcal vaccine naïve subjects 10 through 17 years of age (study 
MET50*)  

Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

 

MenACWY-CRM  
(95% CI) 

 
A N=463 N=464 

% ≥1:8 (Seroprotection) 93.5 (90.9; 95.6) 82.8 (79.0; 86.1) 
% Seroresponse**# 75.6 (71.4; 79.4) 66.4 (61.9; 70.7) 
hSBA GMT 44.1 (39.2; 49.6) 35.2 (30.3; 41.0) 

C N=462 N=463 
% ≥1:8 (Seroprotection) 98.5 (96.9; 99.4) 76.0  (71.9; 79.8) 
% Seroresponse**# 97.2 (95.2; 98.5) 72.6 (68.3; 76.6) 
hSBA GMT 387  (329; 456) 51.4  (41.2; 64.2) 

W N=463 N=464 
% ≥1:8 (Seroprotection) 99.1  (97.8; 99.8) 90.7  (87.7; 93.2) 
% Seroresponse**# 86.2 (82.7; 89.2) 66.6 (62.1; 70.9) 
hSBA GMT 86.9  (77.8; 97.0) 36.0 (31.5; 41.0) 

Y N=463 N=464 
% ≥1:8 (Seroprotection) 97.2  (95.2; 98.5) 83.2  (79.5; 86.5) 
% Seroresponse**# 97.0  (95.0; 98.3) 80.8  (76.9; 84.3) 
hSBA GMT 75.7 (66.2; 86.5) 27.6 (23.8; 32.1) 

* Clinical trial identifier NCT02199691 
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 



12 
 

** Post-vaccination hSBA titres ≥1:8 for subjects with pre-vaccination hSBA titres < 1:8 or at least a 4-fold increase in hSBA titres from pre to 
post-vaccination for subjects with pre-vaccination hSBA titres ≥1:8  
# Non-inferiority criterion met. 
 
Study MET43 was performed to evaluate the immunogenicity of MenQuadfi compared to 
MenACWY-DT in children, adolescents and adults (10-55 years of age). 
 
Table 6: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-DT 30 days 
after vaccination in meningococcal vaccine naïve subjects 10 through 17 years of age (study 
MET43*) 
 

Endpoint by Serogroup MenQuadfi 
(95% CI)  

MenACWY-DT  
(95% CI) 

 
A N=1,097 N=300 

% ≥1:8 (Seroprotection) 96.2  (94.9; 97.2) 89.0  (84.9; 92.3) 
% Seroresponse** 74.0  (71.3; 76.6) 55.3  (49.5; 61.0) 
hSBA GMT 78  (71.4; 85.2) 44.2  (36.4; 53.7) 

C N=1,097-1,098 N=300 
% ≥1:8 (Seroprotection) 98.5 (97.5; 99.1) 74.7 (69.3; 79.5) 
% Seroresponse** 95.6 (94.2; 96.8) 53.3  (47.5; 59.1) 
hSBA GMT 504  (456; 558) 44.1  (33.7; 57.8) 

W N=1,097 N=300 
% ≥1:8 (Seroprotection) 98.3  (97.3; 99.0) 93.7  (90.3; 96.1) 
% Seroresponse** 84.5  (82.2; 86.6) 72.0  (66.6; 77.0) 
hSBA GMT 97.2  (88.3; 107) 59.2  (49.1; 71.3) 

Y N=1,097 N=300 
% ≥1:8 (Seroprotection) 99.1  (98.3; 99.6) 94.3  (91.1; 96.7) 
% Seroresponse** 95.6  (94.2; 96.8) 85.7  (81.2; 89.4) 
hSBA GMT 208  (189; 228) 80.3  (65.6; 98.2) 

* Clinical trial identifier NCT02842853 
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met. 
 
Adults 18 through 55 years of age 
Immunogenicity in subjects from 18 through 55 years of age was evaluated in study MET43 
(NCT02842853) comparing MenQuadfi to MenACWY-DT.  
 
Table 7: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-DT 30 days 
after vaccination in meningococcal vaccine naïve subjects 18 through 55 years of age (study 
MET43*) 
 

Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

 

MenACWY-DT (95% CI) 

A N=1,406-1,408 N=293 
% ≥1:8 (Seroprotection) 93.5 (92.1; 94.8) 88.1 (83.8; 91.5) 
% Seroresponse** 73.5 (71.2; 75.8) 53.9 (48.0; 59.7) 
hSBA GMT 106 (97.2; 117) 52.3 (42.8; 63.9) 



13 
 

Endpoint by 
Serogroup 

MenQuadfi 
(95% CI) 

 

MenACWY-DT (95% CI) 

C N=1,406-1,408 N=293 
% ≥1:8 (Seroprotection) 93.5 (92.0; 94.7) 77.8 (72.6; 82.4) 
% Seroresponse** 83.4 (81.4; 85.3) 42.3 (36.6; 48.2) 
hSBA GMT 234 (210; 261) 37.5 (29.0; 48.5) 

W N=1,408-1,410 N=293 
% ≥1:8 (Seroprotection) 94.5 (93.2; 95.7) 80.2 (75.2; 84.6) 
% Seroresponse** 77.0 (74.7; 79.2) 50.2 (44.3; 56.0) 
hSBA GMT 75.6 (68.7; 83.2) 33.2 (26.3; 42.0) 

Y N=1,408-1,410 N=293 
% ≥1:8 (Seroprotection) 98.6  (97.8; 99.1) 81.2  (76.3; 85.5) 
% Seroresponse** 88.1 (86.3; 89.8) 60.8 (54.9; 66.4) 
hSBA GMT 219  (200; 239) 54.6  (42.3; 70.5) 

* Clinical trial identifier NCT02842853 
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met. 
 
Adults 56 years of age and older 
Immunogenicity in adults ≥ 56 years of age (mean 67.1 years, range 56.0 – 97.2 years) was assessed in 
study MET49 (NCT02842866) comparing the immunogenicity of MenQuadfi to MenACWY 
polysaccharide vaccine. 
 
Table 8: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY 
polysaccharide in meningococcal vaccine naïve in subjects 56 years of age and older 30 days after 
vaccination (study MET49*) 
 

Serogroup Endpoint MenQuadfi 
(95% CI) 

 

MenACWY polysaccharide 
(95% CI) 

 
A N=433 N=431 

% ≥1:8 (Seroprotection) 89.4 (86.1; 92.1) 84.2 (80.4; 87.5) 
% Seroresponse** 58.2 (53.4; 62.9) 42.5 (37.7; 47.3) 
hSBA GMT 55.1 (46.8; 65.0) 31.4 (26.9; 36.7) 

C N=433 N=431 
% ≥1:8 (Seroprotection) 90.1 (86.9; 92.7) 71.0 (66.5; 75.2) 
% Seroresponse** 77.1 (72.9; 81.0) 49.7 (44.8; 54.5) 
hSBA GMT 101 (83.8; 123) 24.7 (20.7; 29.5) 

W N=433 N=431 
% ≥1:8 (Seroprotection) 77.4 (73.1; 81.2) 63.1 (58.4; 67.7) 
% Seroresponse** 62.6 (57.8; 67.2) 44.8 (40.0; 49.6) 
hSBA GMT 28.1 (23.7; 33.3) 15.5 (13.0; 18.4) 

Y N=433 N=431 
% ≥1:8 (Seroprotection) 91.7 (88.7; 94.1) 67.7 (63.1; 72.1) 
% Seroresponse** 74.4 (70.0; 78.4) 43.4  (38.7; 48.2) 
hSBA GMT 69.1 (58.7; 81.4) 21.0 (17.4; 25.3) 

* Clinical trial identifier NCT02842866 
N: number of subjects in the per-protocol analysis set with valid serology results. 



14 
 

95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met. 
 
Booster response 
Study MET56 (NCT02752906) compared the immunogenicity of a booster dose of MenQuadfi with a 
booster dose of MenACWY-DT in subjects at least 15 years of age. These subjects were primed with a 
quadrivalent meningococcal conjugate vaccine (MenACWY-CRM (11.3%) or with MenACWY-DT 
(86.3%)) 4 to 10 years earlier.   
At baseline, hSBA seroprotection and GMT were similar for serogroups A, C, W, and Y. 
 
Table 9: Comparison of bactericidal antibody responses to MenQuadfi and MenACWY-DT 30 days 
after booster vaccination (study MET56*) 
 

Serogroup Endpoint MenQuadfi 
(95% CI) 

 

MenACWY-DT (95% CI) 
 

A N=384 N=389 
% ≥1:8 (Seroprotection) 100.0 (99.0; 100.0) 99.0 (97.4; 99.7) 
% Seroresponse** 92.2 (89.0; 94.7) 87.1 (83.4; 90.3) 
hSBA GMT 497 (436; 568) 296 (256; 343) 

C N=384 N=389 
% ≥1:8 (Seroprotection) 99.5  (98.1; 99.9) 99.0  (97.4; 99.7) 
% Seroresponse** 97.1 (94.9; 98.6) 91.8 (88.6; 94.3) 
hSBA GMT 2,618 (2,227; 3,078) 599 (504; 711) 

W N=384 N=389 
% ≥1:8 (Seroprotection) 100.0 (99.0; 100.0) 99.7 (98.6; 100.0) 
% Seroresponse** 98.2 (96.3; 99.3) 90.7 (87.4; 93.4) 
hSBA GMT 1,747 (1,508; 2,025) 723 (614; 853) 

Y N=384 N=389 
% ≥1:8 (Seroprotection) 99.7  (98.6; 100.0) 99.5  (98.2; 99.9) 
% Seroresponse** 97.4 (95.3; 98.7) 95.6 (93.1; 97.4) 
hSBA GMT 2,070 (1,807; 2,371) 811 (699; 941) 

* Clinical trial identifier NCT02752906 
N: number of subjects in the per-protocol analysis set with valid serology results. 
95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met. 
 
Clinical data are not yet available after booster vaccination in subjects primed with MenQuadfi. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies within one or 
more subsets of the paediatric population under 12 months of age (see 4.2 for information on paediatric 
use). 
 
5.2 Pharmacokinetic properties  
 
No pharmacokinetic studies have been performed. 
 



15 
 

5.3 Preclinical safety data  
 
Non-clinical safety data revealed no special risks for humans based on a developmental and reproductive 
toxicity study in female rabbits. 
 
The administration of MenQuadfi to female rabbits at a full human dose showed no effects on mating 
performance, female fertility, no teratogenic potential, and no effect on pre- or post-natal development. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients  
 
Sodium chloride 
Sodium acetate 
Water for injections 
 
6.2 Incompatibilities  
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life  
 
42 months 
 
6.4 Special precautions for storage  
 
Store in a refrigerator (2°C – 8°C).  
Do not freeze.  
 
6.5 Nature and contents of container  
 
Solution in a Type I borosilicate clear glass vial with a 13 mm chlorobutyl stopper and a flip off seal. 
Pack of 1 or 5 single dose (0.5 mL) vials. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling  
 
The vaccine should be inspected visually for any particulate matter and/or variation of physical aspect (or 
discolouration) prior to administration. In the event of either being observed, discard the vaccine. 
 
Preparation 
Remove the flip off seal and using a suitable syringe and needle, withdraw 0.5 mL of solution, ensuring 
no air bubbles are present before injection. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 



16 
 

7. MARKETING AUTHORISATION HOLDER 
 
Sanofi Pasteur 
14 Espace Henry Vallée 
69007 Lyon 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1483/001 - 1 single dose vial  
EU/1/20/1483/002 - 5 single dose vials  
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


17 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



18 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance(s)  
 
Sanofi Pasteur 
One Discovery Drive 
Swiftwater PA 18370 
United States 
 
Name and address of the manufacturer(s) responsible for batch release  
 
Sanofi Pasteur 
One Discovery Drive 
Swiftwater PA 18370 
United States 
 
Sanofi Pasteur 
Parc Industriel d’Incarville  
27100 Val de Reuil 
France 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
• Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a 
state laboratory or a laboratory designated for that purpose. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 
any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months 
following authorisation. 
 
 



19 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 
USE OF THE MEDICINAL PRODUCT   

 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of an 
important (pharmacovigilance or risk minimisation) milestone being reached. 

 
• Obligation to conduct post-authorisation measures  
 
The MAH shall complete, within the stated timeframe, the below measures: 
 

Description Due date 

Study MET62: Immunogenicity and Safety of an Investigational Quadrivalent 
Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children 
Vaccinated 3 Years Earlier as Toddlers 

 

Q2 2021 

Study MET59: Immunogenicity and safety of a booster dose of an investigational 
quadrivalent MenACYW conjugate vaccine in adolescents and adults  

 

Q2 2022 

Study MEQ00066: Safety and immunogenicity of a single dose of MenACYW 
conjugate vaccine at least 3 years following initial vaccination with either 
Menomune® vaccine or MenACYW conjugate vaccine in Older Adults  

 

Q1 2024 

  



20 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III  
 

LABELLING AND PACKAGE LEAFLET  
  



21 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING  
  



22 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
 OUTER BOX  
 
 
1. NAME OF THE MEDICINAL PRODUCT  
 
MenQuadfi, solution for injection 
Meningococcal group A, C, W and Y conjugate vaccine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S)  
 
Each dose (0.5 mL) contains 10 micrograms of polysaccharide of each Neisseria meningitidis group: A, 
C, W and Y (conjugated to 55 micrograms tetanus toxoid carrier protein).  
 
 
3. LIST OF EXCIPIENTS  
 
Excipients: sodium chloride, sodium acetate, water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS  
 
Solution for injection 
1 single dose vial (0.5 mL) 
5 single dose vials (0.5 mL) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION  
 
Read the package leaflet before use. 
Intramuscular use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN  
 
Keep out of the sight and reach of children.  
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY  
 
 
8. EXPIRY DATE  
 
EXP  
 



23 
 

 
9. SPECIAL STORAGE CONDITIONS  
 
Store in a refrigerator.  
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE  

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER  
 
Sanofi Pasteur 
14 Espace Henry Vallée 
69007 Lyon 
France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1483/001 - 1 single dose vial  
EU/1/20/1483/002 - 5 single dose vials  
 
 
13. BATCH NUMBER  
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY  
 
 
15. INSTRUCTIONS ON USE  
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



24 
 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



25 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION  
 
MenQuadfi, solution for injection 
Meningococcal group A, C, W and Y conjugate vaccine 
IM 
 
 
2. METHOD OF ADMINISTRATION  
 
 
3. EXPIRY DATE  
 
EXP  
 
 
4. BATCH NUMBER  
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT  
 
1 dose (0.5 mL) 
 
 
6. OTHER  
 
Sanofi Pasteur 
 
 
  



26 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET  



27 
 

Package leaflet: Information for the user  
 

MenQuadfi, solution for injection  
Meningococcal group A, C, W and Y conjugate vaccine 

 
This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 
 
Read all of this leaflet carefully before you or your child are given this vaccine because it contains 
important information for you or your child. 
• Keep this leaflet. You may need to read it again.  
• If you have any further questions, ask your doctor, pharmacist or nurse. 
• This vaccine has been prescribed for you or your child only. Do not pass it on to others  
• If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. This includes any 

possible side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What MenQuadfi is and what it is used for  
2. What you need to know before you or your child are given MenQuadfi  
3. How MenQuadfi is given 
4. Possible side effects  
5. How to store MenQuadfi 
6. Contents of the pack and other information 
 
 
1. What MenQuadfi  is and what it is used for 
 
What MenQuadfi is used for 
MenQuadfi  is a vaccine that can be given to children from 1 year of age, adolescents and adults.  
 
MenQuadfi helps to protect against infections caused by a type of bacteria (germs) called “Neisseria 
meningitidis”, specifically against types A, C, W and Y.  
 
Neisseria meningitidis bacteria (also called meningococci) can be passed from person to person and can 
cause serious and sometimes life-threatening infections, such as:  
• Meningitis – an inflammation of the tissues that surround the brain and spinal cord; 
• Septicaemia – an infection of the blood.  
Both infections can result in serious disease with long lasting effects or possibly death.  
 
MenQuadfi should be used in accordance with official national guidelines. 
 
How the vaccine works 
MenQuadfi works by stimulating the vaccinated person natural defense (immune system), to produce 
protective antibodies against the bacteria. 
 
MenQuadfi only helps to protect against illnesses caused by Neisseria meningitidis types A, C, W and Y.  
• It does not protect against infections caused by other types of Neisseria meningitidis. 
• It does not protect against meningitis or septicaemia caused by other bacteria or viruses.  



28 
 

 
As with any vaccine, MenQuadfi may not fully protect all the people who are vaccinated. 
 
 
2. What you need to know before you are given MenQuadfi 
 
Do not have MenQuadfi if you or your child  
• are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in 

section 6) or have experienced a previous allergic reaction to this vaccine.  
 
If you are not sure, talk to your doctor, pharmacist or nurse before you or your child are given 
MenQuadfi. 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before vaccination with MenQuadfi if you or your child have: 
• an infection with high temperature (over 38°C). If this applies, the vaccination will be given after 

the infection is under control. There is no need to delay vaccination for a minor infection such as a 
cold. However, talk to your doctor, pharmacist or nurse first. 

• a bleeding problem or bruise easily. 
• ever fainted from an injection. Fainting, sometimes accompanied by falling, can occur (mostly in 

adolescents) after, or even before, any injection. 
• a weak immune system (such as due to HIV infection, other disease, or use of a medicine that 

affect the immune system), as you or your child may not fully benefit from having MenQuadfi. 
If any of the above apply to you or your child (or you are not sure whether they apply), talk to your 
doctor, pharmacist or nurse before you or your child are given MenQuadfi. 

 
As with any vaccine, MenQuadfi may not fully protect all of those who get the vaccine.  
 
Other medicines and MenQuadfi 
Tell your doctor, pharmacist, or nurse if you or your child are taking, have recently taken or might take 
any other vaccines or medicines, including medicines obtained without a prescription. 
 
In particular, tell your doctor, pharmacist, or nurse if you or your child are taking any medicines that 
affect your immune system, such as:  
• high-dose corticosteroids  
• chemotherapy.  
 
MenQuadfi may be given at the same time as other vaccines at separate injection site during the same 
visit. These include the vaccines that protect against measles, mumps, rubella, varicella, diphtheria, 
tetanus, pertussis, polio, Haemophilus influenzae type b, hepatitis B, pneumococcal and human 
papillomavirus infections.  
 
Pregnancy and breast-feeding  
If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your 
doctor, pharmacist, or nurse for advice before receiving MenQuadfi. 
 
Driving and using machines  
MenQuadfi is not likely to affect your ability to drive, cycle or use machines. However, do not drive, 
cycle or use any machines if you are not feeling well. 
 



29 
 

 
MenQuadfi contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per dose, this means that it is essentially 
‘sodium-free’. 
 
 
3. How MenQuadfi is given 
 
MenQuadfi is given by a doctor or nurse as a 0.5 ml injection in the muscle. It is given in the upper arm 
or in the thigh depending on the age and how much muscle you or your child have.  
 
 
4. Possible side effects 
 
Like all vaccines, MenQuadfi can cause side effects, although not everybody gets them. 
 
If you or your child get any of these symptoms after the vaccination; 

•  itchy skin rash 
•  shortness of breath 
•  swelling of the face or tongue.  

Contact your doctor immediately. This could be signs of an allergic reaction. 
 
Possible side effects in children aged 12 to 23 months:  
 
Very common (may affect more than 1 in 10 children) 
• tenderness, redness, or swelling where the injection was given  
• feeling irritable 
• crying 
• loss of appetite  
• feeling drowsy  
 
Common (may affect up to 1 in 10 children) 
• fever 
• vomiting  
• diarrhoea  
 
Uncommon (may affect up to 1 in 100 people): 
• difficulty sleeping 
• hives 
• itching, bruising, firmness, or rash where the injection was given 
 
Possible side effects in children (2 years of age and older), adolescents and adults: 
 
Very common (may affect more than 1 in 10 people) 
• pain where the injection was given  
• muscle pain 
• headache 
• generally feeling unwell  

 



30 
 

Common (may affect up to 1 in 10 people) 
• redness or swelling where the injection was given 
• fever 

 
Uncommon (may affect up to 1 in 100 people) 
• itching, warmth, bruising or rash where the injection was given  
• vomiting  
• feeling dizzy 
• nausea  
• fatigue (feeling tired) 

 
Rare (may affect up to 1 in 1,000 people) 
• enlarged lymph nodes 
• diarrhoea, stomach pain 
• hives, itching, rash 
• pain in the arms or legs  
• chills, pain in the armpit  
• injection site firmness 
 
Reporting of side effects  
If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. This includes any 
possible side effects not listed in this leaflet. You can also report side effects directly via the national 
reporting system listed in Appendix V. By reporting side effects, you can help provide more information 
on the safety of this medicine. 
 
 
5. How to store MenQuadfi 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the carton after EXP. 
 
Store in a refrigerator (2°C to 8°C). 
Do not freeze. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What MenQuadfi contains  
 
One dose (0.5 ml) contains: 
 
- The active substances are 

- Neisseria meningitidis group A polysaccharide1  10 micrograms 
- Neisseria meningitidis group C polysaccharide1  10 micrograms 
- Neisseria meningitidis group Y polysaccharide1  10 micrograms 
- Neisseria meningitidis group W polysaccharide1  10 micrograms 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


31 
 

- 1Conjugated to tetanus toxoid carrier protein  55 micrograms  
 

- The other ingredients are 
- sodium chloride 
- sodium acetate 
- water for injections 

 
What MenQuadfi looks like and contents of the pack 
MenQuadfi is a clear colourless solution for injection. 
MenQuadfi is available in packs of 1 or 5 single dose (0.5 ml) vials. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder  
Sanofi Pasteur 
14 Espace Henry Vallée 
69007 Lyon 
France 
 
Manufacturer 
Sanofi Pasteur 
One Discovery Drive 
Swiftwater PA 18370 
United States 
 
Sanofi Pasteur 
Parc Industriel d’Incarville  
27100 Val de Reuil 
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/ Belgique /Belgien 
Sanofi Belgium 
tel.: +32 2 710.54.00 
 

Lietuva 
Sanofi – Aventis Lietuva, UAB 
Tel.: +370 5 2755224   

България 
Sanofi Bulgaria EOOD  
Teл.: +359 2 970 53 00 

Luxembourg/Luxemburg 
Sanofi Belgium 
tel.: +32 2 710.54.00 
 

Česká republika 
Sanofi Pasteur 
divize. vakcín sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 

Magyarország 
sanofi-aventis zrt 
Tel.: +36 1 505 0055 

Danmark 
Sanofi A/S 
Tel: +45 4516 7000  
 

Malta 
Sanofi S.r.l. 
Tel: +39 02 39394983 



32 
 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel.: 0800 54 54 010 
Tel. aus dem Ausland: +49 69 305 21 130 
 

Nederland 
Genzyme Europe B.V. 
Tel: +31 20 245 4000 

Eesti 
Sanofi-Aventis Estonia OÜ 
Tel.: +372 627 3488 
 

Norge 
Sanofi-aventis Norge AS 
Tel: + 47 67 10 71 00 

Ελλάδα 
ΒΙΑΝΕΞ Α.Ε.  
Τηλ: +30.210.8009111 

Österreich 
Sanofi-Aventis GmbH 
Tel: +43 (1) 80185-0. 
 

España 
sanofi-aventis, S.A.  
Tel: +34 93 485 94 00 

Polska 
Sanofi Pasteur Sp. z o.o. 
Tel.: +48 22 280 05 00 
 

France 
Sanofi Pasteur Europe 
Tél: 0800 42 43 46 
Appel depuis l’étranger : +33 1 57 63 67 97 

Portugal 
Sanofi – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 35 89 400 
 
 

Hrvatska 
sanofi-aventis Croatia d.o.o 
Tel.: +385 1 6003 400 
 
Ireland 
sanofi-aventis Ireland T/A SANOFI 
Tel: + 353 (0) 1 4035 600 

România 
Sanofi Romania SRL 
Tel.: +40(21) 317 31 36 
 
Slovenija 
sanofi-aventis d.o.o. 
Tel.: +386 1 560 48 00  
 

Ísland 
Vistor 
Tel : +354 535 7000 

Slovenská republika 
Sanofi-aventis Slovakia s.r.o. 
divízia vakcín Sanofi Pasteur 
Tel.: +421 2 33 100 100 
 

Italia 
Sanofi S.r.l. 
Tel: 800536389  
Tel dall'estero: +39 02 39394983 
 

Suomi/Finland 
Sanofi Oy 
Tel: +358 (0) 201 200 300 
 

Κύπρος 
Γ. Α. Σταμάτης & Σια Λτδ. 
Τηλ.: +357 – 22766276 
 

Sverige 
Sanofi AB 
Tel: +46 8-634 50 00 

Latvija 
Sanofi Aventis Latvia SIA Vakcīnu nodaļa 
Tel.: +371 67114978 

United Kingdom 
Sanofi 
Tel: +44 845 372 7101 

  
This leaflet was last revised in {MM/YYYY}.  
 



33 
 

 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET