Nimenrix

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1.  NAME OF THE MEDICINAL PRODUCT 
 
Nimenrix powder and solvent for solution for injection in pre-filled syringe 
Meningococcal groups A, C, W-135 and Y conjugate vaccine 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, 1 dose (0.5 ml) contains: 
 
Neisseria meningitidis group A polysaccharide1 5 micrograms 
Neisseria meningitidis group C polysaccharide1 5 micrograms 
Neisseria meningitidis group W-135 polysaccharide1 5 micrograms 
Neisseria meningitidis group Y polysaccharide1 5 micrograms 
 
1conjugated to tetanus toxoid carrier protein 44 micrograms 
 
For the full list of excipients, see section 6.1. 
 
 
3.  PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
The powder or cake is white. 
The solvent is clear and colourless. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1  Therapeutic indications 
 
Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive 
meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. 
 
4.2  Posology and method of administration 
 
Posology 
 
Nimenrix should be used in accordance with available official recommendations. 
 
Primary immunisation 
Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered 
with an interval of 2 months between doses. 
 
Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be 
administered.  
An additional primary dose of Nimenrix may be considered appropriate for some individuals (see 
section 4.4). 
 
Booster doses 
After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, 
a booster dose should be given at 12 months of age with an interval of at least 2 months after the last 
Nimenrix vaccination (see section 5.1). 
 



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In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster 
dose if they have received primary vaccination with a conjugated or plain polysaccharide 
meningococcal vaccine (see sections 4.4 and 5.1). 
 
Method of administration 
 
Immunisation should be carried out by intramuscular injection only. 
 
In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 
1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid 
muscle (see sections 4.4 and 4.5). 
 
For instructions on reconstitution of the medicinal product 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. 
 
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. 
 
Nimenrix should under no circumstances be administered intravascularly, intradermally or 
subcutaneously. 
 
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. 
 
Appropriate medical treatment and supervision should always be readily available in case of a rare 
anaphylactic event following the administration of the vaccine. 
 
Intercurrent illness 
 
Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile 
illness. The presence of a minor infection, such as a cold, should not result in the deferral of 
vaccination. 
 
Syncope 
 
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as 
a psychogenic response to the needle injection. This can be accompanied by several neurological 
signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during 
recovery. It is important that procedures are in place to avoid injury from faints. 
 
Thrombocytopenia and coagulation disorders 
 
Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation 
disorder since bleeding may occur following an intramuscular administration to these subjects. 
 
Immunodeficiency 
 
It may be expected that in patients receiving immunosuppressive treatment or patients with 
immunodeficiency, an adequate immune response may not be elicited. 



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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 for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even 
if they develop antibodies following vaccination with Nimenrix. 
 
Protection against meningococcal disease 
 
Nimenrix will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The 
vaccine will not protect against any other Neisseria meningitidis groups. 
 
A protective immune response may not be elicited in all vaccinees. 
 
Effect of prior vaccination with plain polysaccharide meningococcal vaccine 
Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated 
with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with a 
serum bactericidal assay using rabbit complement (rSBA) than subjects who had not been vaccinated 
with any meningococcal vaccine in the preceding 10 years (see section 5.1). The clinical relevance of 
this observation is unknown. 
 
Effect of pre-vaccination antibody to tetanus toxoid 
The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or 
co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, 
inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b 
polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib) in the second year of 
life. The administration of Nimenrix one month after the DTaP-HBV-IPV/Hib vaccine resulted in 
lower rSBA GMTs against groups A, C and W-135 compared with co-administration (see section 4.5). 
The clinical relevance of this observation is unknown. 
 
Immune response in infants aged 6 months to less than 12 months 
A single dose administered at 6 months was associated with lower human complement serum 
bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 
4, and 6 months (see section 5.1). The clinical relevance of this observation is unknown. If an infant 
aged 6 months to less than 12 months is expected to be at particular risk of invasive meningococcal 
disease due to exposure to groups W-135 and/or Y, consideration may be given to administering a 
second primary dose of Nimenrix after an interval of 2 months. 
 
Immune responses in toddlers aged 12-14 months 
Toddlers aged 12-14 months had similar rSBA titres to groups A, C, W-135 and Y at one month after 
one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart. 
 
A single dose was associated with lower hSBA titres to groups W-135 and Y compared with two 
doses given two months apart. Similar responses to groups A and C were observed after one or two 
doses (see section 5.1). The clinical relevance of the findings is unknown. If a toddler is expected to be 
at particular risk of invasive meningococcal disease due to exposure to groups W-135 and/or Y, 
consideration may be given to administering a second dose of Nimenrix after an interval of 2 months. 
Regarding waning of antibody against group A or group C after a first dose of Nimenrix in children 
aged 12-23 months, see under Persistence of serum bactericidal antibody titres. 
 
Persistence of serum bactericidal antibody titres 
 
Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against 
group A when using hSBA (see section 5.1). The clinical relevance of this observation is unknown. 
However, if an individual is expected to be at particular risk of exposure to group A and received a 
dose of Nimenrix more than approximately one year previously, consideration may be given to 
administering a booster dose. 
 



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A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical 
relevance of this observation is unknown. A booster dose might be considered in individuals 
vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by 
groups A, C, W-135 or Y (see section 5.1). 
 
Effect of Nimenrix on anti-tetanus antibody concentrations 
 
Although an increase of the anti-tetanus toxoid (TT) antibody concentrations was observed following 
vaccination with Nimenrix, Nimenrix does not substitute for tetanus immunisation. 
 
Giving Nimenrix with or one month before a TT-containing vaccine in the second year of life does not 
impair the response to TT or significantly affect safety. No data are available beyond the age of 
2 years. 
 
Sodium content 
 
This vaccine 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 
 
In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and 
with 10-valent pneumococcal conjugate vaccine. 
 
From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: 
hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, 
measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or 
unadjuvanted seasonal influenza vaccine. 
 
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - 
tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, 
inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-
IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 
 
In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus 
bivalent [Type 16 and 18] vaccine, recombinant (HPV2). 
 
Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, 
should be co-administered or Nimenrix should be administered at least one month before the TT 
containing vaccine. 
 
One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower 
Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody 
GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier 
protein). The clinical relevance of this observation is unknown. There was no impact of 
co-administration on immune responses to the other nine pneumococcal serotypes. 
 
One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and 
acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were 
observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and 
pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the 
assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no 
impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens 
included in Tdap. 
 
If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always 
be administered at different injection sites. 



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It may be expected that in patients receiving immunosuppressive treatment, an adequate response may 
not be elicited. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There is limited experience with use of Nimenrix in pregnant women. 
 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, 
embryo/foetal development, parturition or post-natal development (see section 5.3). 
 
Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages 
outweigh the potential risks for the foetus. 
 
Breast-feeding 
 
It is unknown whether Nimenrix is excreted in human milk. 
 
Nimenrix should only be used during breast-feeding when the possible advantages outweigh the 
potential risks. 
 
Fertility 
 
Animal studies do not indicate direct or indirect harmful effects with respect to fertility. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects of Nimenrix on the ability to drive and use machines have been performed. 
However, some of the effects mentioned under section 4.8 “Undesirable effects” may affect the ability 
to drive or use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:  

 A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This total 
included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 
990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults 
(18 to 55 years). 

 Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study 
MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 
doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age. 

 
Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was 
administered to 274 individuals aged 56 years and older. 
 
Local and general adverse reactions 
In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 
2 months apart, the first and second doses were associated with similar local and systemic 
reactogenicity. 
 
The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 
12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or 
plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction 



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profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms 
(including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age 
and older. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported 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) 
Very rare: (<1/10,000) 
Not known (cannot be estimated from available data) 
 
Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 
55 years of age and post-marketing experience. Adverse reactions reported in subjects aged >55 years 
were similar to those observed in younger adults. 
 
Table 1: Tabulated summary of adverse reactions by system organ class 
System Organ Class Frequency Adverse reactions 
Metabolism and nutrition 
disorders 

Very common Appetite lost 

Psychiatric disorders 
 

Very common Irritability
Uncommon Insomnia 

Crying
Nervous system disorders 
 

Very common Drowsiness 
Headache

Uncommon Hypoaesthesia 
Dizziness

Gastrointestinal disorders 
 

Common Diarrhoea 
Vomiting 
Nausea*

Skin and subcutaneous tissue 
disorders 

Uncommon Pruritus 
Rash**

Musculoskeletal and connective 
tissue disorders 

Uncommon Myalgia 
Pain in extremity

General disorders and 
administration site conditions 
 

Very common Fever 
Swelling at injection site 
Pain at injection site 
Redness at injection site 
Fatigue

Common Injection site haematoma* 
Uncommon Malaise 

Injection site induration 
Injection site pruritus 
Injection site warmth 
Injection site anaesthesia

 Not known*** Extensive limb swelling at the injection site, 
frequently associated with erythema, 
sometimes involving the adjacent joint or 
swelling of the entire injected limb 

*Nausea and Injection site haematoma occurred at a frequency of Uncommon in infants 
**Rash occurred at a frequency of Common in infants 
***ADR identified post-marketing 
 



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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 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08 
 
Mechanism of action 
 
Anti-capsular meningococcal antibodies protect against meningococcal disease via complement 
mediated bactericidal activity. Nimenrix induces the production of bactericidal antibodies against 
capsular polysaccharides of Neisseria meningitidis groups A, C, W-135 and Y when measured by 
assays using either rSBA or hSBA. 
 
Immunogenicity in infants 
 
In Study MenACWY-TT-083, the first dose was administered at 6 to 12 weeks of age, the second after 
an interval of 2 months, and a third (booster) dose administered at approximately 12 months of age. 
DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine were co-administered. Nimenrix elicited 
rSBA and hSBA titres against the four meningococcal groups as shown in Table 2. The response 
against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines 
in terms of percentages with rSBA titres ≥8 at 1 month after the second dose.  
 
Data from this study support the extrapolation of the immunogenicity data and posology to infants 
from 12 weeks to less than 6 months of age. 
 



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Table 2: rSBA and hSBA titres following two doses of Nimenrix (or MenC-CRM or MenC-TT) 

given 2 months apart with the first dose administered to infants 6-12 weeks of age and 
following a booster at 12 months of age (Study MenACWY-TT-083) 

Meningo-
coccal 
group 

Vaccine 
group 

Time 
point 

rSBA* hSBA** 

N 
8 GMT 

N 
8 GMT 

(95% CI) (95% CI) (95% CI) (95% CI) 

A Nimenrix 

Post-
dose 2(1) 456 

97.4% 
(95.4; 98.6)

203 
(182; 227) 202 

96.5%  
(93.0; 98.6) 

157  
(131; 188)

Post-
booster(1)  462 

99.6%  
(98.4; 99.9)

1561  
(1412; 1725) 214 

99.5% 
(97.4;100) 

1007 
(836;1214)

C 

Nimenrix 

Post-
dose 2(1) 456 

98.7%  
(97.2; 99.5)

612  
(540; 693) 218 

98.6%  
(96.0; 99.7) 

1308  
(1052; 1627)

Post-
booster(1) 463 

99.8%  
(98.8; 100)

1177  
(1059; 1308) 221 

99.5%  
(97.5; 100) 

4992  
(4086; 6100)

MenC-
CRM 

vaccine 

Post-
dose 2(1) 455 

99.6%  
(98.4; 99.9)

958  
(850; 1079) 202 

100%  
(98.2; 100) 

3188  
(2646; 3841)

Post-
booster(1) 446 

98.4%  
(96.8; 99.4)

1051  
(920; 1202) 216 

100%  
(98.3; 100) 

5438  
(4412; 6702)

MenC-
TT 

vaccine 

Post-
dose 2(1) 457 

100%  
(99.2; 100)

1188  
(1080; 1307) 226 

100%  
(98.4; 100) 

2626  
(2219; 3109)

Post-
booster(1) 459 

100%  
(99.2; 100)

1960  
(1776; 2163) 219 

100%  
(98.3; 100) 

5542  
(4765; 6446)

W Nimenrix 

Post-
dose 2(1) 455 

99.1%  
(97.8; 99.8)

1605  
(1383; 1862) 217 

100%  
(98.3; 100) 

753 
(644; 882)

Post-
booster(1) 462 

99.8%  
(98.8; 100)

2777  
(2485; 3104) 218 

100%  
(98.3; 100) 

5123  
(4504; 5826)

Y Nimenrix 

Post-
dose 2(1) 456 

98.2%  
(96.6; 99.2)

483  
(419; 558) 214 

97.7%  
(94.6; 99.2) 

328  
(276; 390)

Post-
booster(1) 462 

99.4%  
(99.1; 99.9)

881  
(787; 986) 217 

100% 
(98.3; 100) 

2954  
(2498; 3493)

The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort. 
*rSBA analysis performed at Public Health England (PHE) laboratories in UK 
**hSBA analysis performed at GSK laboratories 
(1) blood sampling performed 21 to 48 days post vaccination
 
In Study MenACWY-TT-087, infants received either a single primary dose at 6 months followed by a 
booster dose at 15-18 months (DTaP-IPV/Hib and 10-valent pneumococcal conjugate vaccine was 
co-administered at both vaccination time points) or three primary doses at 2, 4, and 6 months followed 
by a booster dose at 15-18 months. A single primary dose administered at 6 months of age elicited 
robust rSBA titres to the four meningococcal groups, as measured by the percentage of subjects with 
rSBA titres ≥8, that were comparable to responses after the last dose of a three-dose primary series. A 
booster dose produced robust responses, comparable between the two dosing groups, against all four 
meningococcal groups. Results are shown in Table 3.  
 



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Table 3: rSBA and hSBA titres following a single dose of Nimenrix in infants at 6 months of age 
and pre-and post-booster at 15-18 months of age (Study MenACWY-TT-087) 

Meningo-
coccal 
group  

Time 
point 

rSBA* hSBA** 

N 8 (95% CI) 
GMT 

(95% CI) N 
8 

(95% CI) 
GMT 

(95% CI) 

A 

Post-dose 
1(1) 163 

98.8% 
(95.6; 99.9) 

1333 
(1035; 1716) 59 

98.3% 
(90.9; 100) 

271 
(206; 355) 

Pre-
booster 131 

81.7% 
(74; 87.9) 

125 
(84.4; 186) 71 

66.2% 
(54; 77) 

20.8 
(13.5; 32.2) 

Post-
booster(1)  139 

99.3% 
(96.1; 100) 

2762 
(2310; 3303) 83 

100% 
(95.7; 100) 

1416 
(1140; 1758) 

C 

Post-dose 
1(1) 163 

99.4% 
(96.6; 100) 

592 
(482; 726) 66 

100% 
(94.6;100) 

523 
(382; 717) 

Pre-
booster 131 

65.6% 
(56.9; 73.7) 

27.4 
(20.6; 36.6) 78 

96.2% 
(89.2; 99.2) 

151 
(109; 210) 

Post-
booster(1) 139 

99.3% 
(96.1; 100) 

2525 
(2102; 3033) 92 

100% 
(96.1; 100) 

13360 
(10953; 16296) 

W 

Post-dose 
1(1) 163 

93.9% 
(89; 97) 

1256 
(917; 1720) 47 

87.2% 
(74.3; 95.2) 

137 
(78.4; 238) 

Pre-
booster 131 

77.9% 
(69.8; 84.6) 

63.3 
(45.6; 87.9) 53 

100% 
(93.3; 100) 

429 
(328; 559) 

Post-
booster(1) 139 

100% 
(97.4; 100) 

3145 
(2637; 3750) 59 

100% 
(93.9; 100) 

9016 
(7045; 11537) 

Y 

Post-dose 
1(1) 163 

98.8% 
(95.6; 99.9) 

1470 
(1187; 1821) 52 

92.3% 
(81.5; 97.9) 

195 
(118; 323) 

Pre-
booster 131 

88.5% 
(81.8; 93.4) 

106 
(76.4; 148) 61 

98.4% 
(91.2; 100) 

389 
(292; 518) 

Post-
booster(1) 139 

100% 
(97.4; 100) 

2749 
(2301; 3283) 69 

100% 
(94.8; 100) 

5978 
(4747; 7528) 

The analysis of immunogenicity was conducted on the primary ATP cohort. 
*rSBA analysis performed at PHE laboratories in UK 
**hSBA analysis performed at Neomed in Canada 
(1) blood sampling performed 1 month post vaccination  

 
Measurement of hSBA titres was a secondary endpoint in Study MenACWY-TT-087. Although 
similar responses to groups A and C were observed with both dosing schedules, a single primary dose 
in infants at 6 months was associated with lower hSBA titres to groups W-135 and Y as measured by 
the percentage of subjects with hSBA titres ≥8 [87.2% (95% CI: 74.3, 95.2) and 92.3% (95% CI: 81.5, 
97.9), respectively] compared with three primary doses at 2, 4, and 6 months of age [100% (95% CI: 
96.6, 100) and 100% (95% CI: 97.1, 100), respectively] (see section 4.4). After a booster dose, hSBA 
titres to all four meningococcal groups were comparable between the two dosing schedules. Results 
are shown in Table 3. 
 



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Immunogenicity in toddlers aged 12-23 months 
 
In clinical studies MenACWY-TT-039 and MenACWY-TT-040, a single dose of Nimenrix elicited 
SBA titres against the four meningococcal groups, with group C rSBA titres that were comparable to 
those elicited by a licensed MenC-CRM vaccine in terms of the percentage of subjects with rSBA 
titres ≥8. In Study MenACWY-TT-039, hSBA was also measured as a secondary endpoint. Results are 
shown in Table 4. 
 
Table 4: SBA* titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 

12-23 months (Studies MenACWY-TT-039/040) 
Meningo
-coccal 
group 

Vaccine 
group 

Study MenACWY-TT-039(1) Study MenACWY-TT-040(2)
rSBA*  hSBA* rSBA* 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI)
GMT 

(95% CI)

A Nimenrix 354 99.7% (98.4; 100) 
2205 

(2008; 2422) 338
77.2% 

(72.4; 81.6)
19.0 

(16.4; 22.1) 183 
98.4% 

(95.3; 99.7)
3170 

(2577; 3899)

C 
Nimenrix 354 99.7% (98.4; 100) 

478 
(437; 522) 341

98.5% 
(96.6; 99.5)

196 
(175; 219) 183 

97.3% 
(93.7; 99.1)

829 
(672; 1021)

MenC-CRM 
vaccine 121 

97.5% 
(92.9; 99.5) 

212 
(170; 265) 116

81.9% 
(73.7; 88.4)

40.3 
(29.5; 55.1) 114 

98.2% 
(93.8; 99.8)

691 
(521; 918)

W-135 Nimenrix 354 100% (99.0; 100) 
2682 

(2453; 2932) 336
87.5% 

(83.5 ; 90.8)
48.9 

(41.2; 58.0) 186 
98.4% 

(95.4; 99.7)
4022 

(3269; 4949)

Y Nimenrix 354 100% (99.0; 100) 
2729 

(2473; 3013) 329
79.3% 

(74.5; 83.6)
30.9 

(25.8; 37.1) 185 
97.3% 

(93.8; 99.1)
3168 

(2522; 3979)
The analysis of immunogenicity was conducted on the ATP cohorts. 
(1) blood sampling performed 42 to 56 days post vaccination 
(2) blood sampling performed 30 to 42 days post vaccination 
* SBA analyses performed at GSK laboratories 
 
In Study MenACWY-TT-104, Nimenrix elicited rSBA titres against all four meningococcal groups 
following one or two doses administered 2 months apart that were similar in terms of the percentage of 
subjects with rSBA titre ≥8 and GMT as shown in Table 5. 
 
Table 5: rSBA and hSBA titres following one or two doses of Nimenrix with the first dose 

administered to toddlers aged 12-14 months (Study MenACWY-TT-104) 
Meningo- 

coccal 
group 

Nimenrix 
dose 

group 

Time 
point(1) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

A 

1 dose Post dose 1 180 97.8% (94.4; 99.4) 
1437 

(1118; 1847) 74 
95.9% 

(88.6, 99.2) 
118 

(86.8; 161) 

2 doses 
Post dose 1 158 96.8% (92.8; 99.0) 

1275 
(970; 1675) 66 

97.0% 
(89.5; 99.6) 

133 
(98.1; 180) 

Post dose 2 150 98.0% (94.3; 99.6)
1176 

(922; 1501) 66 
97.0% 

(89.5; 99.6) 
170 

(126; 230)

C 

1 dose Post dose 1 179 95.0% (90.7; 97.7) 
452 

(346; 592) 78 
98.7% 

(93.1; 100) 
152 

(105; 220) 

2 doses 
Post dose 1 157 95.5% (91.0; 98.2) 

369 
(281; 485) 70 

95.7% 
(88.0; 99.1) 

161 
(110; 236) 

Post dose 2 150 98.7% (95.3; 99.8)
639 

(522; 783) 69 
100% 

(94.8; 100) 
1753 

(1278; 2404)



12 

Meningo- 
coccal 
group 

Nimenrix 
dose 

group 

Time 
point(1) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

W-135 

1 dose Post dose 1 180 95.0% (90.8; 97.7) 
2120 

(1601; 2808) 72 
62.5% 

(50.3; 73.6) 
27.5 

(16.1; 46.8) 

2 doses 
Post dose 1 158 94.9% (90.3; 97.8) 

2030 
(1511; 2728) 61 

68.9% 
(55.7; 80.1) 

26.2 
(16.0; 43.0) 

Post dose 2 150 100% (97.6; 100)
3533 

(2914; 4283) 70 
97.1% 

(90.1; 99.7) 
757 

(550; 1041)

Y 

1 dose Post dose 1 180 92.8% (88.0; 96.1) 
952 

(705; 1285) 71 
67.6% 

(55.5; 78.2) 
41.2 

(23.7; 71.5) 

2 doses 
Post dose 1 157 93.6% (88.6; 96.9) 

933 
(692; 1258) 56 

64.3% 
(50.4; 76.6) 

31.9 
(17.6; 57.9) 

Post dose 2 150 99.3% (96.3; 100)
1134 

(944; 1360) 64 
95.3% 

(86.9; 99.0) 
513 

(339; 775)
The analysis of immunogenicity was conducted on the ATP cohort.  
(1) blood sampling performed 21-48 days post vaccination 
*rSBA analysis performed at PHE laboratories 
**hSBA analysis performed at GSK laboratories 
 
In Study MenACWY-TT-104, hSBA titres were measured as a secondary endpoint. Nimenrix elicited 
hSBA titres against groups W-135 and Y that were higher in terms of the percentage of subjects with 
hSBA titre ≥8 when two doses were given compared with one (see section 4.4). Nimenrix elicited 
hSBA titres against groups A and C that were similar in terms of the percentage of subjects with hSBA 
titre ≥8 when two doses were given compared with one. Results are shown in Table 5. 
 
rSBA and hSBA titres were determined over a period of 10 years in children initially vaccinated with 
one dose of Nimenrix or MenC-CRM at 12 to 23 months of age in Study MenACWY-TT-027. 
Persistence of SBA titres was evaluated in two extension studies: MenACWY-TT-032 (up to 5 years) 
and MenACWY-TT-100 (up to 10 years). Study MenACWY-TT-100 also evaluated the response to a 
single booster dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix 
or MenC-CRM. Results are shown in Table 6 (see section 4.4). 
 
Table 6: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 

12-23 months, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo
coccal 
group 

Vaccine 
group 

Time point 
 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A Nimenrix 

Month 1(1)  222 100% (98.4; 100)
3707 

(3327; 4129) 217
91.2% 

(86.7; 94.6) 
59.0 

(49.3; 70.6)

Year 4(2)  45 64.4% (48.8; 78.1)
35.1 

(19.4; 63.4) 44 
52.3% 

(36.7; 67.5) 
8.8 

(5.4; 14.2)

Year 5(2) 49 73.5% (58.9; 85.1)
37.4 

(22.1; 63.2) 45 
35.6% 

(21.9: 51.2) 
5.2 

(3.4; 7.8)
Year 10(3)  
 (Pre-booster) 62

66.1% 
(53.0; 77.7)

28.9 
(16.4; 51.0) 59 

25.4% 
(15.0; 38.4) 

4.2 
(3.0; 5.9)

 (Post-booster)(3,4) 62 98.4%  (91.3; 100)
5122 

(3726; 7043) 62 
100% 

(94.2; 100) 
1534 

(1112; 2117)



13 

Table 6: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo
coccal 
group 

Vaccine 
group 

Time point 
 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

C 

Nimenrix 

Month 1(1)  220 100% (98.3; 100)
879 

(779; 991) 221
99.1% 

(96.8; 99.9) 
190 

(165; 219)

Year 4(2) 45 97.8% (88.2; 99.9)
110 

(62.7; 192) 45 
97.8% 

(88.2; 99.9) 
370 

(214; 640)

Year 5(2) 49 77.6% (63.4; 88.2)
48.9 

(28.5; 84.0) 48 
91.7% 

(80.0; 97.7) 
216 

(124; 379)
Year 10(3) 
 (Pre-booster) 62

82.3% 
(70.5; 90.8)

128 
(71.1; 231) 60 

91.7% 
(81.6; 97.2) 

349 
(197; 619)

 (Post-booster)(3,4) 62 100% (94.2; 100)
7164 

(5478; 9368) 59 
100% 

(93.9; 100) 
33960 

(23890; 48274)

MenC-
CRM 

vaccine 

Month 1(1)  68 98.5% (92.1; 100)
415 

(297; 580) 68 
72.1% 

(59.9; 82.3) 
21.2 

(13.9; 32.3)

Year 4(2)  10 80.0% (44.4; 97.5)
137 

(22.6; 832) 10 
70.0% 

(34.8; 93.3) 
91.9 

(9.8; 859)

Year 5(2)  11 63.6% (30.8; 89.1)
26.5 

(6.5; 107) 11 
90.9% 

(58.7; 99.8) 
109 

(21.2; 557)
Year 10(3) 
 (Pre-booster) 16

87.5% 
(61.7; 98.4)

86.7  
(29.0; 259) 15 

93.3% 
(68.1; 99.8) 

117 
(40.0; 344)

 (Post-booster)(3,4) 16 100% (79.4; 100)
5793 

(3631; 9242) 15 
100%  

(78.2; 100) 
42559 

(20106; 90086)

W-135 Nimenrix 

Month 1(1)  222 100% (98.4; 100)
5395 

(4870; 5976) 177
79.7% 

(73.0; 85.3) 
38.8 

(29.7; 50.6)

Year 4(2) 45 60.0% (44.3; 74.3)
50.8 

(24.0; 108) 45 
84.4% 

(70.5; 93.5) 
76.9 

(44.0; 134)

Year 5(2) 49 34.7% (21.7; 49.6)
18.2 

(9.3; 35.3) 46 
82.6% 

(68.6; 92.2) 
59.7 

(35.1; 101)
Year 10(3) 
 (Pre-booster) 62

30.6% 
(19.6; 43.7)

15.8 
(9.1; 27.6) 52 

44.2% 
(30.5; 58.7) 

7.7 
(4.9; 12.2)

 (Post-booster)(3,4) 62 100% (94.2; 100)
25911 

(19120; 35115) 62 
100% 

(94.2; 100) 
11925 

(8716; 16316)

Y Nimenrix 

Month 1(1)  222 100% (98.4; 100)
2824 

(2529; 3153) 201
66.7% 

(59.7; 73.1) 
24.4 

(18.6; 32.1)

Year 4(2)  45 62.2% (46.5; 76.2)
44.9 

(22.6; 89.3) 41 
87.8% 

(73.8; 95.9) 
74.6 

(44.5; 125)

Year 5(2)  49 42.9% (28.8; 57.8)
20.6 

(10.9; 39.2) 45 
80.0% 

(65.4; 90.4) 
70.6 

(38.7; 129)
Year 10(3) 
 (Pre-booster) 62

45.2% 
(32.5; 58.3)

27.4 
(14.7; 51.0) 56 

42.9% 
(29.7; 56.8) 

9.1 
(5.5; 15.1)

 (Post-booster)(3,4) 62 98.4% (91.3; 100)
7661  

(5263; 11150) 61 
100% 

(94.1; 100) 
12154 

(9661; 15291)
The analysis of immunogenicity was conducted on the ATP cohorts for 1 month and 5 years post vaccination 
and the booster ATP cohort. Subjects with a suboptimal response to meningococcal group C (defined as SBA 
titre below the pre-defined assay cut-off) were to receive an additional dose of MenC vaccine before Year 6. 
These subjects were excluded from the analysis at Years 4 and 5 but included in the analysis at Year 10. 

(1) Study MenACWY-TT-027 
(2) Study MenACWY-TT-032 
(3) Study MenACWY-TT-100 
(4) Blood sampling was performed 1 month after a booster dose at Year 10.  

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for subsequent sampling time points. 
** hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-
TT-100. 
 



14 

Persistence of booster response 
Study MenACWY-TT-102 evaluated the persistence of SBA titres up to 6 years after a booster dose of 
Nimenrix or MenC-CRM197 administered in Study MenACWY-TT-048 to children who initially 
received the same vaccine at 12 to 23 months of age in Study MenACWY-TT-039. A single booster 
dose was administered 4 years after the initial vaccination. Results are shown in Table 7 
(see section 4.4). 
 

Table 7: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence at 4 years and response following a booster 4 years after initial 
vaccination, and persistence up to 6 years following booster vaccination (Studies MenACWY-
TT-039/048/102) 

Meningo
-coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A Nimenrix 

Month 1(1) 354 99.7% (98.4; 100)
2205 

(2008; 2422) 338
77.2% 

(72.4; 81.6) 
19.0 

(16.4; 22.1)
Year 4(2) 
(Pre-Nimenrix 
booster) 

212 74.5% (68.1; 80.2) 
112 

(80.3; 156) 187
28.9% 

(22.5; 35.9) 4.8 (3.9; 5.9) 

(Post-booster)(2,3) 214 100% (98.3; 100)
7173 

(6389; 8054) 202
99.5% 

(97.3; 100) 
1343 

(1119; 1612)
5 years after 
booster dose(4) 137 

89.8% 
(83.4; 94.3)

229 
(163; 322) 135

53.3% 
(44.6; 62.0) 

13.2 
(9.6; 18.3)

6 years after 
booster dose(4) 134 

92.5% 
(86.7; 96.4)

297 
(214; 413) 130

58.5% 
(49.5; 67.0) 

14.4 
(10.5; 19.7)

C 

Nimenrix 

Month 1(1) 354 99.7% (98.4; 100)
478 

(437; 522) 341
98.5% 

(96.6; 99.5) 
196 

(175; 219)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 39.9% (33.3; 46.8) 
12.1 

(9.6; 15.2) 200
73.0% 

(66.3; 79.0) 
31.2 

(23.0; 42.2) 

(Post-booster)(2,3) 215 100% (98.3; 100)
4512 

(3936; 5172) 209
100%  

(98.3; 100) 
15831 

(13626; 18394)
5 years after 
booster dose(4) 137 

80.3% 
(72.6; 86.6)

66.0 
(48.1; 90.5) 136

99.3% 
(96.0; 100) 

337 
(261; 435)

6 years after 
booster dose(4) 134 

71.6% 
(63.2; 79.1)

39.6 
(28.6; 54.6) 130

97.7% 
(93.4; 99.5) 

259 
(195; 345)

MenC-
CRM 

vaccine 

Month 1(1) 121 97.5% (92.9; 99.5)
212 

(170; 265) 116
81.9% 

(73.7; 88.4) 
40.3 

(29.5; 55.1)
Year 4(2) 
(Pre-MenC-
CRM197 booster) 

43 37.2% (23.0; 53.3) 
14.3 

(7.7; 26.5) 31 
48.4% 

(30.2; 66.9) 
11.9 

(5.1; 27.6) 

(Post-booster)(2,3) 43 100% (91.8; 100)
3718 

(2596; 5326) 33 
100% 

(89.4; 100) 
8646 

(5887; 12699)
5 years after 
booster dose(4) 23 

78.3% 
(56.3; 92.5)

47.3 
(19.0; 118) 23 

100% 
(85.2; 100) 

241 
(139; 420)

6 years after 
booster dose(4) 23 

65.2% 
(42.7; 83.6)

33.0 
(14.7; 74.2) 23 

95.7% 
(78.1; 99.9) 

169 
(94.1; 305)

W-135 Nimenrix 

Month 1(1) 354 100% (99.0; 100)
2682 

(2453; 2932) 336
87.5% 

(83.5; 90.8) 
48.9 

(41.2; 58.0)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 48.8% (41.9; 55.7) 
30.2 

(21.9; 41.5) 158
81.6% 

(74.7; 87.3) 
48.3 

(36.5; 63.9) 

(Post-booster)(2,3) 215 100% (98.3; 100)
10950 

(9531; 12579) 192
100% 

(98.1; 100) 
14411 

(12972; 16010)
5 years after 
booster dose(4) 137 

88.3% 
(81.7; 93.2)

184  
(130; 261) 136

100% 
(97.3; 100) 

327 
(276; 388)

6 years after 
booster dose(4) 134 

85.8% 
(78.7; 91.2)

172 
(118; 251) 133

98.5% 
(94.7; 99.8) 

314 
(255; 388)



15 

Table 7: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence at 4 years and response following a booster 4 years after initial 
vaccination, and persistence up to 6 years following booster vaccination (Studies MenACWY-
TT-039/048/102) 

Meningo
-coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

Y Nimenrix 

Month 1(1) 354 100% (99.0; 100)
2729 

(2473; 3013) 329
79.3% 

(74.5; 83.6) 
30.9 

(25.8; 37.1)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 58.2% (51.3; 64.9) 
37.3 

(27.6; 50.4) 123
65.9% 

(56.8; 74.2) 
30.2 

(20.2; 45.0) 

(Post-booster)(2,3) 215 100% (98.3; 100)
4585 

(4129; 5093) 173
100% 

(97.9; 100) 
6776 

(5961; 7701)
5 years after 
booster dose(4) 137 

92.7% 
(87.0; 96.4)

265 
(191; 368) 137

97.8% 
(93.7; 99.5) 

399 
(321; 495)

6 years after 
booster dose(4) 134 

94.0% 
(88.6; 97.4)

260 
(189; 359) 131

97.7% 
(93.5; 99.5) 

316 
(253; 394)

The analysis of immunogenicity was conducted on the ATP cohort for each time point. 
(1) Study MenACWY-TT-039 
(2) Study MenACWY-TT-048 
(3) Blood sampling was performed 1 month after a booster dose at Year 4. 
(4) Study MenACWY-TT-102 

* rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-TT-
102. 
 
Immunogenicity in children aged 2-10 years 
 
In Study MenACWY-TT-081, a single dose of Nimenrix was demonstrated to be non-inferior to 
another licensed MenC-CRM vaccine in terms of vaccine response to group C [94.8% (95% CI: 91.4; 
97.1) and 95.7% (95% CI: 89.2; 98.8), respectively]. The GMT was lower for the Nimenrix group 
[2795 (95% CI: 2393; 3263)] versus the MenC-CRM vaccine [5292 (95% CI: 3815; 7340)]. 
 
In Study MenACWY-TT-038, a single dose of Nimenrix was demonstrated to be non-inferior to the 
licensed ACWY-PS vaccine in terms of vaccine response to the four meningococcal groups as shown 
in Table 8. 
 



16 

Table 8: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in children aged 2-
10 years (Study MenACWY-TT-038) 

Meningo
-coccal 
group 

Nimenrix(1) ACWY-PS vaccine(1) 

N VR (95% CI) 
GMT 

(95% CI) N 
VR 

(95% CI) 
GMT 

(95% CI) 

A 594 89.1% (86.3; 91.5) 
6343 

(5998; 6708) 192 
64.6% 

(57.4; 71.3) 
2283 

(2023; 2577) 

C 691 96.1% (94.4; 97.4) 
4813 

(4342; 5335) 234 
89.7% 

(85.1; 93.3) 
1317 

(1043; 1663) 

W-135 691 97.4% (95.9; 98.4) 
11543 

(10873; 12255) 236 
82.6% 

(77.2; 87.2) 
2158 

(1815; 2565) 

Y 723 92.7% (90.5; 94.5) 
10825 

(10233; 11452) 240 
68.8% 

(62.5; 74.6) 
2613 

(2237; 3052) 
The analysis of immunogenicity was conducted on the ATP cohort . 
(1) Blood sampling performed 1 month post vaccination 
VR: vaccine response defined as the proportion of subjects with: 
 rSBA titres ≥32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8) 
 at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive 

subjects (i.e., pre-vaccination rSBA titre ≥8) 
* rSBA analysis performed at GSK laboratories 
 
Persistence of SBA titres was evaluated in children initially vaccinated in Study MenACWY-TT-081 
as shown in Table 9 (see section 4.4). 
 
Table 9: rSBA and hSBA titres up to 44 months following Nimenrix (or MenC-CRM) in 

children aged 2-10 years at time of vaccination (Study MenACWY-TT-088) 
Meningo

coccal 
group 

Vaccine 
group 

Time 
point 

(months) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

A Nimenrix 
32 193 86.5% (80.9; 91.0)

196 
(144; 267) 90 

25.6% 
(16.9; 35.8) 

4.6 
(3.3; 6.3)

44 189 85.7% (79.9; 90.4)
307 

(224; 423) 89 
25.8% 

(17.1; 36.2) 
4.8 

(3.4; 6.7)

C 

Nimenrix 
32 192 64.6% (57.4; 71.3)

34.8 
(26.0; 46.4) 90 

95.6% 
(89.0; 98.8) 

75.9 
(53.4; 108)

44 189 37.0% (30.1; 44.3)
14.5 

(10.9; 19.2) 82 
76.8% 

(66.2; 85.4) 
36.4 

(23.1; 57.2)

MenC-
CRM 

vaccine 

32 69 76.8% (65.1; 86.1)
86.5 

(47.3; 158) 33 
90.9% 

(75.7; 98.1) 
82.2 

(34.6; 196)

44 66 45.5% (33.1; 58.2)
31.0 

(16.6; 58.0) 31 
64.5% 

(45.4; 80.8) 
38.8 

(13.3; 113)

W-135 Nimenrix 
32 193 77.2% (70.6; 82.9)

214 
(149; 307) 86 

84.9% 
(75.5; 91.7) 

69.9 
(48.2; 101)

44 189 68.3% (61.1; 74.8)
103 

(72.5; 148) 87 
80.5% 

(70.6; 88.2) 
64.3 

(42.7; 96.8)

Y Nimenrix 
32 193 81.3% (75.1; 86.6)

227 
(165; 314) 91 

81.3% 
(71.8; 88.7) 

79.2 
(52.5; 119)

44 189 62.4% (55.1; 69.4)
78.9 

(54.6; 114) 76 
82.9% 

(72.5; 90.6) 
127 

(78.0; 206)
The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time point. 
*rSBA analysis performed at PHE laboratories in UK 
** hSBA analysis performed at GSK laboratories 
 
Persistence of hSBA titres was evaluated 1 year after vaccination in children aged 6-10 years who 
were initially vaccinated in Study MenACWY-TT-027 (Table 10) (see section 4.4). 
 



17 

Table 10: hSBA* titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
6-10 years and persistence 1 year following vaccination (Studies MenACWY-TT-
027/028) 

Mening
ococcal 
group 

Vaccine 
group 

1 month post-vaccination 
(Study MenACWY-TT-027) 

1 year persistence 
(Study MenACWY-TT-028) 

N 8 (95% CI) 
GMT 

(95% CI) N 
8 

(95% CI) 
GMT 

(95% CI) 

A 
Nimenrix 105 80.0 % (71.1; 87.2)

53.4 
(37.3; 76.2) 104 

16.3% 
(9.8; 24.9) 

3.5 
(2.7; 4.4)

ACWY-PS 
vaccine 35 

25.7% 
(12.5; 43.3)

4.1 
(2.6; 6.5) 35 

5.7% 
(0.7; 19.2) 

2.5 
(1.9; 3.3)

C 
Nimenrix 101 89.1% (81.3; 94.4)

156 
(99.3; 244) 105 

95.2% 
(89.2; 98.4) 

129 
(95.4; 176)

ACWY-PS 
vaccine 38 

39.5% 
(24.0; 56.6)

13.1 
(5.4; 32.0) 31 

32.3% 
(16.7; 51.4) 

7.7 
(3.5; 17.3)

W-135 
Nimenrix 103 95.1% (89.0; 98.4)

133 
(99.9; 178) 103 

100% 
(96.5; 100) 

257 
(218; 302)

ACWY-PS 
vaccine 35 

34.3% 
(19.1; 52.2)

5.8 
(3.3; 9.9) 31 

12.9% 
(3.6; 29.8) 

3.4 
(2.0; 5.8)

Y 
Nimenrix 89 83.1% (73.7;90.2)

95.1 
(62.4; 145) 106 

99.1% 
(94.9; 100) 

265 
(213; 330)

ACWY-PS 
vaccine 32 

43.8% 
(26.4; 62.3)

12.5 
(5.6; 27.7) 36 

33.3% 
(18.6; 51.0) 

9.3 
(4.3; 19.9)

The analysis of immunogenicity was conducted on the ATP cohort for persistence at Year 1. 
hSBA analysis was not performed for children aged 2 to <6 years (at time of vaccination).  
* hSBA analysis performed at GSK laboratories 
 
SBA titres were determined over a period of 10 years in children initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 2 to 10 years of age in Study MenACWY-TT-027. Persistence of SBA 
titres was evaluated in two extension studies: MenACWY-TT-032 (up to 5 years) and MenACWY-
TT-100 (up to 10 years). Study MenACWY-TT-100 also evaluated the response to a single booster 
dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-
PS. Results are shown in Table 11 (see section 4.4). 
 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
7301 

(6586; 8093) 111
(5) 81.1% 

(72.5; 87.9) 
57.0 

(40.3; 80.6)

Year 5(2) 98 90.8% (83.3; 95.7)
141 

(98.2; 203) n/a
(6) -- -- 

Year 6(3) 98 79.6% (70.3; 87.1)
107 

(66.0; 174) 90 
41.1% 

(30.8; 52.0) 
6.5 

(4.8; 8.8)
Year 10(3)  
(Pre-booster) 73 

89.0% 
(79.5; 95.1)

96.3 
(57.1; 163) 62 

33.9% 
(22.3; 47.0) 

4.5 
(3.3; 6.2)

(Post-booster)(3,4) 74 95.9% (88.6; 99.2)
4626 

(3041; 7039) 73 
100% 

(95.1; 100) 
1213 

(994; 1481)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
2033 

(1667; 2480) 35
(5) 25.7% (12.5; 43.3) 

4.1 
(2.6; 6.5)

Year 5(2) 13 15.4% (1.9; 45.4)
4.7 

(3.7; 6.0) n/a
(6) -- -- 

Year 6(3)  24 12.5% (2.7; 32.4)
5.8 

(3.5; 9.6) 21 
33.3% 

(14.6; 57.0) 
5.9 

(3.0; 11.7)
Year 10(3)  
(Pre-booster) 17 

23.5% 
(6.8; 49.9)

8.0 
(3.3; 19.3) 17 

29.4% 
(10.3; 56.0) 

6.2  
(2.4; 15.7)



18 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

(Post-booster)(3,4) 17 100% (80.5; 100)
6414 

(3879; 10608) 17 
100% 

(80.5; 100) 
211 

(131; 340)

C 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
2435 

(2106; 2816) 107
(5) 89.7% 

(82.3; 94.8) 
155 

(101; 237)

Year 5(2) 98 90.8% (83.3; 95.7)
79.7 

(56.0; 113) n/a
(6) -- -- 

Year 6(3)  98 82.7% (73.7; 89.6)
193 

(121; 308) 97 
93.8% 

(87.0; 97.7) 
427 

(261; 700)
Year 10(3)  
(Pre-booster) 74 

85.1% 
(75.0; 92.3)

181 
(106; 310) 73 

91.8% 
(83.0; 96.9) 

222 
(129; 380)

(Post-booster)(3,4) 74 100% (95.1; 100)
4020 

(3319; 4869) 71 
100% 

(94.9; 100) 
15544 

(11735; 20588)

ACWY-
PS 

vaccine 

Month 1(1) 74 100% (95.1; 100)
750 

(555; 1014) 38
(5) 39.5% (24.0; 56.6) 

13.1 
(5.4; 32.0)

Year 5(2) 13 100% (75.3; 100)
128 

(56.4; 291) n/a
(6) -- -- 

Year 6(3)  24 79.2% (57.8; 92.9)
98.7 

(42.2; 231) 24 
100% 

(85.8; 100) 
235 

(122; 451)
Year 10(3)  
(Pre-booster) 17 

76.5% 
(50.1; 93.2)

96.2 
(28.9; 320) 17 

100% 
(80.5; 100) 

99.1 
(35.8; 274)

(Post-booster)(3,4) 17 100% (80.5; 100)
15101 

(7099; 32122) 17 
94.1 

(71.3; 99.9) 
44794 

(10112; 198440)

W-135 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
11777 

(10666; 13004) 107
(5) 95.3% 

(89.4; 98.5) 
134 

(101; 178)

Year 5(2) 98 78.6% (69.1; 86.2)
209 

(128; 340) n/a
(6) -- -- 

Year 6(3)  98 73.5% (63.6; 81.9)
265 

(155; 454) 92 
81.5% 

(72.1; 88.9) 
62.5 

(42.0; 93.1)
Year 10(3)  
(Pre-booster) 74 

68.9% 
(57.1; 79.2)

206 
(109; 392) 59 

61.0% 
(47.4; 73.5) 

17.5 
(10.5; 29.2)

(Post-booster)(3,4) 74 100% (95.1; 100)
27944 

(22214; 35153) 74 
100% 

(95.1; 100) 
6965 

(5274; 9198)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
2186 

(1723; 2774) 35
(5) 34.3% (19.1; 52.2) 

5.8 
(3.3, 9.9)

Year 5(2) 13 0% (0.0; 24.7)
4.0 

(4.0; 4.0) n/a
(6) -- -- 

Year 6(3)  24 12.5% (2.7; 32.4)
7.6 

(3.7; 15.6) 23 
30.4% 

(13.2; 52.9) 
7.0 

(2.9; 16.9)
Year 10(3)  
(Pre-booster) 17 

23.5% 
(6.8; 49.9)

15.4 
(4.2; 56.4) 15 

26.7% 
(7.8; 55.1) 

4.1 
(2.0; 8.5)

(Post-booster)(3,4) 17 94.1% (71.3; 99.9)
10463 

(3254; 33646) 15 
100% 

(78.2; 100) 
200 

(101; 395)



19 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

Y 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
6641 

(6044; 7297) 94
(5) 83.0% (73.8; 89.9) 

93.7 
(62.1; 141)

Year 5(2) 98 78.6% (69.1; 86.2)
143 

(88.0; 233) n/a
(6) -- -- 

Year 6(3)  98 71.4% (61.4; 80.1)
136 

(82.6; 225) 89 
65.2% 

(54.3; 75.0) 
40.3 

(23.9; 68.1)
Year 10(3)  
 (Pre-booster) 74 

67.6% 
(55.7; 78.0)

98.5 
(54.3; 179) 65 

72.3% 
(59.8; 82.7) 

35.7 
(21.0; 60.6)

 (Post-booster)(3,4) 74 100% (95.1; 100)
7530 

(5828; 9729) 74 
100% 

(95.1; 100) 
11127 

(8909; 13898)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
1410 

(1086; 1831) 32
(5) 43.8% (26.4; 62.3) 

12.5 
(5.6; 27.7)

Year 5(2) 13 7.7% (0.2; 36.0)
5.5 

(2.7; 11.1) n/a
(6) -- -- 

Year 6(3)  24 20.8% (7.1; 42.2)
11.6 

(4.7; 28.7) 24 
25.0% 

(9.8; 46.7) 
7.3 

(2.7; 19.8)
Year 10(3)  
 (Pre-booster) 17 

17.6% 
(3.8; 43.4)

10.2 
(3.5; 30.2) 14 

35.7% 
(12.8; 64.9) 

7.8 
(2.5; 24.4)

 (Post-booster)(3,4) 17 100% (80.5; 100)
6959 

(3637; 13317) 17 
100% 

(80.5; 100) 
454 

(215; 960)
The analysis of immunogenicity was conducted on the ATP cohort for each time point. Subjects with a 
suboptimal response to meningococcal group C (defined as SBA titre below the pre-defined assay cut-off) were 
to receive an additional dose of MenC vaccine before Year 6. These subjects were excluded from the analysis at 
Year 5 but included in the analyses at Years 6 and 10. 

(1) Study MenACWY-TT-027 
(2) Study MenACWY-TT-032 
(3) Study MenACWY-TT-100 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 
(5) Includes children aged 6 to <11 years. hSBA analysis was not performed for children aged 2 to <6 years 

(at time of vaccination). 
(6) Per the protocol for Study MenACWY-TT-032, hSBA was not measured for this age group at Year 5. 

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for subsequent sampling time points. 
**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-TT-
100. 
 
Immunogenicity in adolescents aged 11-17 years and adults aged ≥18 years 
 
In two clinical studies, conducted in adolescents aged 11-17 years (Study MenACWY-TT-036) and in 
adults aged 18-55 years (Study MenACWY-TT-035), either one dose of Nimenrix or one dose of the 
ACWY-PS vaccine was administered. 
 
Nimenrix was demonstrated to be immunologically non-inferior to the ACWY-PS vaccine in terms of 
vaccine response as shown in Table 12. 
 



20 

Table 12: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents 
aged 11-17 years and adults aged 18-55 years (Studies MenACWY-TT-035/036) 

Meningo-
coccal 
group 

Vaccine 
group 

Study MenACWY-TT-036 
(11-17 years)(1) 

Study MenACWY-TT-035 
(18-55 years)(1) 

N VR (95% CI) 
GMT 

(95% CI) N 
VR 

(95% CI) 
GMT 

(95% CI) 

A 

Nimenrix 553 85.4% (82.1; 88.2)
5928 

(5557; 6324) 743 
80.1% 

(77.0; 82.9) 
3625 

(3372; 3897)
ACWY-PS 

vaccine 191 
77.5% 

(70.9; 83.2)
2947 

(2612; 3326) 252 
69.8% 

(63.8; 75.4) 
2127 

(1909; 2370)

C 

Nimenrix 642 97.4% (95.8; 98.5)
13110 

(11939; 14395) 849 
91.5% 

(89.4; 93.3) 
8866 

(8011; 9812)
ACWY-PS 

vaccine 211 
96.7% 

(93.3; 98.7)
8222 

(6807; 9930) 288 
92.0% 

(88.3; 94.9) 
7371 

(6297; 8628)

W-135 

Nimenrix 639 96.4% (94.6; 97.7)
8247 

(7639; 8903) 860 
90.2% 

(88.1; 92.1) 
5136 

(4699; 5614)
ACWY-PS 

vaccine 216 
87.5% 

(82.3; 91.6)
2633 

(2299; 3014) 283 
85.5% 

(80.9; 89.4) 
2461 

(2081; 2911)

Y 

Nimenrix 657 93.8% (91.6; 95.5)
14086 

(13168; 15069) 862 
87.0% 

(84.6; 89.2) 
7711 

(7100; 8374)
ACWY-PS 

vaccine 219 
78.5% 

(72.5; 83.8)
5066 

(4463; 5751) 288 
78.8% 

(73.6; 83.4) 
4314 

(3782; 4921)
The analysis of immunogenicity was conducted on the ATP cohorts. 

(1) Blood sampling performed 1 month post vaccination 
VR: vaccine response defined as the proportion of subjects with: 
 rSBA titres 32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8) 
 at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., 

pre-vaccination rSBA titre ≥8) 
*rSBA analysis performed at GSK laboratories 
 
rSBA titres were determined over a period of 10 years in subjects initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 11 to 17 years of age in Study MenACWY-TT-036. Persistence of rSBA 
titres was evaluated in two extension studies: MenACWY-TT-043 (up to 5 years) and MenACWY-
TT-101 (at 10 years). Study MenACWY-TT-101 also evaluated the response to a single booster dose 
of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-PS. 
Results are shown in Table 13. 
 
Table 13: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents aged 

11-17 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-036/043/101) 

Meningo-
coccal 
group 

Time point 
 

Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Month 1(1) 674 100% (99.5; 100)
5929 

(5557; 6324) 224 
99.6% 

(97.5; 100) 
2947 

(2612; 3326)

Year 3(2) 449 92.9% (90.1; 95.1)
448 

(381; 527) 150 
82.7% 

(75.6; 88.4) 
206 

(147; 288)

Year 5(2) 236 97.5% (94.5; 99.1)
644 

(531; 781) 86 
93.0% 

(85.4; 97.4) 
296 

(202; 433)
Year 10(3)  
 (Pre-booster) 162 

85.2% 
(78.8; 90.3)

248 
(181; 340) 51 

80.4% 
(66.9; 90.2) 

143 
(80.5; 253)

 (Post-booster)(3,4) 162 100% (97.7; 100)
3760 

(3268; 4326) 51 
100% 

(93.0; 100) 
2956 

(2041; 4282)



21 

Table 13: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents aged 
11-17 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-036/043/101) 

Meningo-
coccal 
group 

Time point 
 

Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

C 

Month 1(1) 673 100% (99.5; 100)
13110 

(11939; 14395) 224 
100% 

(98.4; 100) 
8222 

(6808; 9930)

Year 3(2) 449 91.1% (88.1; 93.6)
371 

(309; 446) 150 
86.0% 

(79.4; 91.1) 
390 

(262; 580)

Year 5(2) 236 88.6% (83.8; 92.3)
249 

(194; 318) 85 
87.1% 

(78.0; 93.4) 
366 

(224; 599)
Year 10(3)  
 (Pre-booster) 162 

90.1% 
(84.5; 94.2)

244 
(182; 329) 51 

82.4% 
(69.1; 91.6) 

177 
(86.1; 365)

 (Post-booster)(3,4) 162 100% (97.7; 100)
8698 

(7391 10235) 51 
100% 

(93.0; 100) 
3879 

(2715; 5544)

W-135 

Month 1(1) 678 99.9% (99.2; 100)
8247 

(7639; 8903) 224 
100% 

(98.4; 100) 
2633 

(2299; 3014)

Year 3(2) 449 82.0% (78.1; 85.4)
338 

(268; 426) 150 
30.0% 

(22.8; 38.0) 
16.0 

(10.9; 23.6)

Year 5(2) 236 86.0% (80.9; 90.2)
437 

(324; 588) 86 
34.9% 

(24.9; 45.9) 
19.7 

(11.8; 32.9)
Year 10(3)  
 (Pre-booster) 162 

71.6% 
(64.0; 78.4)

146 
(97.6; 217) 51 

43.1% 
(29.3; 57.8) 

16.4 
(9.2; 29.4)

 (Post-booster)(3,4) 162 100% (97.7; 100)
11243 

(9367; 13496) 51 
100% 

(93.0; 100) 
3674 

(2354; 5734)

Y 

Month 1(1) 677 100% (99.5; 100)
14087 

(13168; 15069) 224 
100% 

(98.4; 100) 
5066 

(4463; 5751)

Year 3(2) 449 93.1% (90.3; 95.3)
740 

(620; 884) 150 
58.0% 

(49.7; 66.0) 
69.6 

(44.6; 109)

Year 5(2) 236 96.6% (93.4; 98.5)
1000 

(824; 1214) 86 
66.3% 

(55.3; 76.1) 
125 

(71.2; 219)
Year 10(3)  
 (Pre-booster) 162 

90.7% 
(85.2; 94.7)

447 
(333; 599) 51 

49.0% 
(34.8; 63.4) 

32.9 
(17.1; 63.3)

 (Post-booster)(3,4) 162 100% (97.7; 100)
7585 

(6748; 8525) 51 
98.0% 

(89.6; 100) 
3296 

(1999; 5434)
The analysis of immunogenicity was conducted on the ATP cohort for each time point. 

(1) Study MenACWY-TT-036 
(2) Study MenACWY-TT-043 
(3) Study MenACWY-TT-101 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
 
hSBA persistence was evaluated up to 5 years after vaccination in adolescents and adults initially 
vaccinated in Study MenACWY-TT-052 as shown in Table 14 (see section 4.4). 
 



22 

Table 14: hSBA* titres following a single dose of Nimenrix in adolescents and adults aged 
11-25 years and persistence up to 5 years following vaccination (Studies MenACWY-
TT-052/059) 

Meningococcal 
group Time point N 8 (95% CI) GMT (95% CI) 

A 
Month 1(1)  356 82.0% (77.6; 85.9) 58.7 (48.6; 70.9) 
Year 1(2)  350 29.1% (24.4; 34.2) 5.4 (4.5; 6.4) 
Year 5(2) 141 48.9% (40.4; 57.5) 8.9 (6.8; 11.8) 

C 
Month 1(1)  359 96.1% (93.5; 97.9) 532 (424; 668) 
Year 1(2)  336 94.9% (92.0; 97.0) 172 (142; 207) 
Year 5(2) 140 92.9% (87.3; 96.5) 94.6 (65.9; 136) 

W-135 
Month 1(1)  334 91.0% (87.4; 93.9) 117 (96.8; 141) 
Year 1(2)  327 98.5% (96.5; 99.5) 197 (173; 225) 
Year 5(2) 138 87.0% (80.2; 92.1) 103 (76.3; 140) 

Y 
Month 1(1)  364 95.1% (92.3; 97.0) 246 (208; 291) 
Year 1(2)  356 97.8% (95.6; 99.0) 272 (237; 311) 
Year 5(2) 142 94.4% (89.2; 97.5) 225 (174; 290) 

The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time point. 
(1) Study MenACWY-TT-052 
(2) Study MenACWY-TT-059  

*hSBA analysis performed at GSK laboratories 
 
rSBA titres were determined over a period of 10 years in subjects initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 11 to 55 years of age in Study MenACWY-TT-015. Persistence of rSBA 
titres was evaluated in two extension studies: MenACWY-TT-020 (up to 5 years) and MenACWY-
TT-099 (up to 10 years). Study MenACWY-TT-099 also evaluated the response to a single booster 
dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-
PS. Results are shown in Table 15. 
 
Table 15: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents and 

adults aged 11-55 years, persistence up to 10 years, and post-booster administered 
10 years following initial vaccination (Studies MenACWY-TT-015/020/099) 

Meningo-
coccal 
group 

Time point 
Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Month 1(1) 323 100% (98.9; 100)
4945 

(4452, 5493) 112
100% 

(96.8, 100) 
2190 

(1858, 2582)

Year 4(2) 43 95.3% (84.2; 99.4)
365 

(226; 590) 17 
76.5% 

(50.1; 93.2) 
104 

(31.0; 351)

Year 5(2) 51 84.3% (71.4; 93.0)
190 

(108; 335) 19 
57.9% 

(33.5; 79.7) 
37.0 

(12.6; 109)
Year 10(3) 
 (Pre-booster) 155 

78.1% 
(70.7; 84.3)

154 
(108; 219) 52 

71.2% 
(56.9; 82.9) 

75.1 
(41.4; 136)

 (Post-booster)(3,4) 155 100% (97.6; 100)
4060 

(3384; 4870) 52 
100% 

(93.2; 100) 
3585 

(2751; 4672)

C 

Month 1(1) 341 99.7% (98.4; 100)
10074 

(8700, 11665) 114
100% 

(96.8; 100) 
6546 

(5048; 8488)

Year 4(2) 43 76.7% (61.4; 88.2)
126 

(61.6; 258) 17 
41.2% 

(18.4; 67.1) 
16.7 

(5.7; 48.7)

Year 5(2) 51 72.5% (58.3; 84.1)
78.5 

(41.8; 147) 18 
38.9% 

(17.3; 64.3) 
17.3 

(6.0; 49.7)
Year 10(3) 
 (Pre-booster) 154 

90.9% 
(85.2; 94.9)

193 
(141; 264) 52 

88.5% 
(76.6; 95.6) 

212 
(110; 412)

 (Post-booster)(3,4) 155 100% (97.6; 100)
13824 

(10840; 17629) 52 
98.1% 

(89.7; 100) 
3444 

(1999; 5936)



23 

Table 15: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents and 
adults aged 11-55 years, persistence up to 10 years, and post-booster administered 
10 years following initial vaccination (Studies MenACWY-TT-015/020/099) 

Meningo-
coccal 
group 

Time point 
Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

W-135 

Month 1(1) 340 99.7% (98.4; 100)
8577 

(7615; 9660) 114
100% 

(96.8; 100) 
2970 

(2439; 3615)

Year 4(2) 43 90.7% (77.9; 97.4)
240 

(128; 450) 17 
17.6% 

(3.8; 43.4) 
8.3 

(3.6; 19.5)

Year 5(2) 51 86.3% (73.7; 94.3)
282 

(146; 543) 19 
31.6% 

(12.6; 56.6) 
15.4 

(5.7; 41.9)
Year 10(3) 
 (Pre-booster) 154 

71.4% 
(63.6; 78.4)

166 
(107; 258) 52 

21.2% 
(11.1; 34.7) 

10.9 
(6.1; 19.3)

 (Post-booster)(3,4) 155 100% (97.6; 100)
23431 

(17351; 31641) 52 
98.1% 

(89.7; 100) 
5793 

(3586; 9357)

Y 

Month 1(1) 340 100% (98.9; 100)
10315 

(9317; 11420) 114
100% 

(96.8; 100) 
4574 

(3864; 5414)

Year 4(2) 43 86.0% (72.1; 94.7)
443 

(230; 853) 17 
47.1% 

(23.0; 72.2) 
30.7 

(9.0; 105)

Year 5(2) 51 92.2% (81.1; 97.8)
770 

(439; 1351) 19 
63.2% 

(38.4; 83.7) 
74.1 

(21.9; 250)
Year 10(3)  
 (Pre-booster) 154 

86.4% 
(79.9; 91.4)

364 
(255; 519) 52 

61.5% 
(47.0; 74.7) 

56.0 
(28.8; 109)

 (Post-booster)(3,4) 155 100% (97.6; 100)
8958 

(7602; 10558) 52 
100% 

(93.2; 100) 
5138 

(3528; 7482)
The analysis of immunogenicity was conducted on the ATP cohorts for 1 month and 5 years post vaccination 
and the booster ATP cohort. 

(1) Study MenACWY-TT-015 
(2) Study MenACWY-TT-020 
(3) Study MenACWY-TT-099 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 

* rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
 
In a separate study (MenACWY-TT-085), a single dose of Nimenrix was administered to 194 
Lebanese adults aged 56 years and older (including 133 aged 56-65 years and 61 aged >65 years). The 
percentage of subjects with rSBA titres (measured at GSK’s laboratories) ≥128 before vaccination 
ranged from 45% (group C) to 62% (group Y). Overall, at 1 month post-vaccination the percentage of 
vaccines with rSBA titres ≥128 ranged from 93% (group C) to 97% (group Y). In the subgroup aged 
>65 years the percentage of vaccines with rSBA titres ≥128 at 1 month post-vaccination ranged from 
90% (group A) to 97% (group Y). 
 
Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against 
Neisseria meningitidis 
 
Nimenrix booster vaccination in subjects previously primed with a monovalent (MenC-CRM) or a 
quadrivalent conjugate meningococcal vaccine (MenACWY-TT) was studied in subjects from 
12 months of age onwards who received a booster vaccination. Robust anamnestic responses to the 
antigen(s) in the priming vaccine were observed (see Tables 6, 7, 11, 13, and 15). 
 
Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against 
Neisseria meningitidis 
 
In Study MenACWY-TT-021 conducted in subjects aged 4.5-34 years, the immunogenicity of 
Nimenrix administered between 30 and 42 months after vaccination with a ACWY-PS vaccine was 
compared to the immunogenicity of Nimenrix administered to age-matched subjects who had not been 
vaccinated with any meningococcal vaccine in the preceding 10 years. An immune response (rSBA 
titre ≥8) was observed against all four meningococcal groups in all subjects regardless of the 



24 

meningococcal vaccine history. The rSBA GMTs were significantly lower in the subjects who had 
received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix, however 100% of subjects 
achieved rSBA titres ≥8 for all four meningococcal groups (A, C, W-135, Y) (see section 4.4). 
 
Children (2-17 years) with anatomical or functional asplenia 
 
Study MenACWY-TT-084 compared immune responses to two doses of Nimenrix given 2 months 
apart between 43 subjects aged 2-17 years with anatomic or functional asplenia subjects and 
43 age-matched subjects with normal splenic function. One month after the first vaccine dose and 
1 month after the second dose similar percentages of subjects in the two groups had rSBA titres ≥8 and 
≥128 and hSBA titres ≥4 and ≥8. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on local tolerance, acute toxicity, 
repeated dose toxicity, developmental/reproductive toxicity and fertility studies. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: 
 
Sucrose 
Trometamol 
 
Solvent: 
 
Sodium chloride 
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  
 
4 years 
 
After reconstitution: 
 
After reconstitution, the vaccine should be used promptly. Although delay is not recommended, 
stability has been demonstrated for 8 hours at 30°C after reconstitution. If not used within 8 hours, do 
not administer the vaccine. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 



25 

 
6.5  Nature and contents of container 
 
Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a 
stopper (butyl rubber). 
Pack sizes of 1 and 10 with or without needles. 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal and other handling 
 
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe 
 
Nimenrix must be reconstituted by adding the entire content of the pre-filled syringe of solvent to the 
vial containing the powder. 
To attach the needle to the syringe, refer to the below picture. However, the syringe provided with 
Nimenrix might be slightly different (without screw thread) than the syringe described in the picture. 
In that case, the needle should be attached without screwing. 
 
1. Holding the syringe barrel in one hand  

(avoid holding the syringe plunger),  
unscrew the syringe cap by twisting it anticlockwise. 

 
 
 
 
 

 
2. To attach the needle to the syringe,  
 twist the needle clockwise into the syringe  
 until you feel it lock (See picture). 
 
 
3. Remove the needle protector, which on 

occasion can be a little stiff. 
 
4. Add the solvent to the powder. After the addition 

of the solvent to the powder, the mixture should 
be well shaken until the powder is completely 
dissolved in the solvent. 

 
The reconstituted vaccine is a clear colourless solution. 
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of physical aspect prior to administration. In the event of either being observed, discard the 
vaccine. 
After reconstitution, the vaccine should be used promptly. 
 
A new needle should be used to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 

Syringe plunger 

Syringe barrel 

Syringe cap 

Needle protector 



26 

7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/767/001 
EU/1/12/767/002 
EU/1/12/767/003 
EU/1/12/767/004 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 April 2012 
Date of latest renewal: 16 February 2017 
 
 
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. 



27 

 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nimenrix powder and solvent for solution for injection in vials 
Meningococcal groups A, C, W-135 and Y conjugate vaccine 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, 1 dose (0.5 ml) contains: 
 
Neisseria meningitidis group A polysaccharide1 5 micrograms 
Neisseria meningitidis group C polysaccharide1 5 micrograms 
Neisseria meningitidis group W-135 polysaccharide1 5 micrograms 
Neisseria meningitidis group Y polysaccharide1 5 micrograms 
 
1conjugated to tetanus toxoid carrier protein 44 micrograms 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
The powder or cake is white. 
The solvent is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive 
meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. 
 
4.2 Posology and method of administration 
 
Posology 
 
Nimenrix should be used in accordance with available official recommendations. 
 
Primary immunisation 
Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered 
with an interval of 2 months between doses. 
 
Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be 
administered.  
An additional primary dose of Nimenrix may be considered appropriate for some individuals (see 
section 4.4). 
 
Booster doses 
After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, 
a booster dose should be given at 12 months of age with an interval of at least 2 months after the last 
Nimenrix vaccination (see section 5.1). 
 



28 

In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster 
dose if they have received primary vaccination with a conjugated or plain polysaccharide 
meningococcal vaccine (see sections 4.4 and 5.1). 
 
Method of administration 
 
Immunisation should be carried out by intramuscular injection only. 
 
In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 
1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid 
muscle (see sections 4.4 and 4.5). 
 
For instructions on reconstitution of the medicinal product 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. 
 
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. 
 
Nimenrix should under no circumstances be administered intravascularly, intradermally or 
subcutaneously. 
 
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. 
 
Appropriate medical treatment and supervision should always be readily available in case of a rare 
anaphylactic event following the administration of the vaccine. 
 
Intercurrent illness 
 
Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile 
illness. The presence of a minor infection, such as a cold, should not result in the deferral of 
vaccination. 
 
Syncope 
 
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as 
a psychogenic response to the needle injection. This can be accompanied by several neurological 
signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during 
recovery. It is important that procedures are in place to avoid injury from faints. 
 
Thrombocytopenia and coagulation disorders 
 
Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation 
disorder since bleeding may occur following an intramuscular administration to these subjects. 
 
Immunodeficiency 
 
It may be expected that in patients receiving immunosuppressive treatment or patients with 
immunodeficiency, an adequate immune response may not be elicited. 



29 

 
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 for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even 
if they develop antibodies following vaccination with Nimenrix. 
 
Protection against meningococcal disease 
 
Nimenrix will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The 
vaccine will not protect against any other Neisseria meningitidis groups. 
 
A protective immune response may not be elicited in all vaccinees. 
 
Effect of prior vaccination with plain polysaccharide meningococcal vaccine 
Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated 
with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with a 
serum bactericidal assay using rabbit complement (rSBA) than subjects who had not been vaccinated 
with any meningococcal vaccine in the preceding 10 years (see section 5.1). The clinical relevance of 
this observation is unknown. 
 
Effect of pre-vaccination antibody to tetanus toxoid 
The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or 
co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, 
inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b 
polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib) in the second year of 
life. The administration of Nimenrix one month after the DTaP-HBV-IPV/Hib vaccine resulted in 
lower rSBA GMTs against groups A, C and W-135 compared with co-administration (see section 4.5). 
The clinical relevance of this observation is unknown. 
 
Immune response in infants aged 6 months to less than 12 months 
A single dose administered at 6 months was associated with lower human complement serum 
bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 
4, and 6 months (see section 5.1). The clinical relevance of this observation is unknown. If an infant 
aged 6 months to less than 12 months is expected to be at particular risk of invasive meningococcal 
disease due to exposure to groups W-135 and/or Y, consideration may be given to administering a 
second primary dose of Nimenrix after an interval of 2 months. 
 
Immune responses in toddlers aged 12-14 months 
Toddlers aged 12-14 months had similar rSBA titres to groups A, C, W-135 and Y at one month after 
one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart. 
 
A single dose was associated with lower hSBA titres to groups W-135 and Y compared with two 
doses given two months apart. Similar responses to groups A and C were observed after one or two 
doses (see section 5.1). The clinical relevance of the findings is unknown. If a toddler is expected to be 
at particular risk of invasive meningococcal disease due to exposure to groups W-135 and/or Y, 
consideration may be given to administering a second dose of Nimenrix after an interval of 2 months. 
Regarding waning of antibody against group A or group C after a first dose of Nimenrix in children 
aged 12-23 months, see under Persistence of serum bactericidal antibody titres. 
 
Persistence of serum bactericidal antibody titres 
 
Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against 
group A when using hSBA (see section 5.1). The clinical relevance of this observation is unknown. 
However, if an individual is expected to be at particular risk of exposure to group A and received a 
dose of Nimenrix more than approximately one year previously, consideration may be given to 
administering a booster dose. 
 



30 

A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical 
relevance of this observation is unknown. A booster dose might be considered in individuals 
vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by 
groups A, C, W-135 or Y (see section 5.1). 
 
Effect of Nimenrix on anti-tetanus antibody concentrations 
 
Although an increase of the anti-tetanus toxoid (TT) antibody concentrations was observed following 
vaccination with Nimenrix, Nimenrix does not substitute for tetanus immunisation. 
 
Giving Nimenrix with or one month before a TT-containing vaccine in the second year of life does not 
impair the response to TT or significantly affect safety. No data are available beyond the age of 
2 years. 
 
Sodium content 
 
This vaccine 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 
 
In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and 
with 10-valent pneumococcal conjugate vaccine. 
 
From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: 
hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, 
measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or 
unadjuvanted seasonal influenza vaccine. 
 
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - 
tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, 
inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-
IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 
 
In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus 
bivalent [Type 16 and 18] vaccine, recombinant (HPV2). 
 
Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, 
should be co-administered or Nimenrix should be administered at least one month before the TT 
containing vaccine. 
 
One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower 
Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody 
GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier 
protein). The clinical relevance of this observation is unknown. There was no impact of 
co-administration on immune responses to the other nine pneumococcal serotypes. 
 
One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and 
acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were 
observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and 
pertactin [PRN]). More than 98% of subjects had anti-PT, FHA or PRN concentrations above the 
assay cut-off thresholds. The clinical relevance of these observations is unknown. There was no 
impact of co-administration on immune responses to Nimenrix or the tetanus or diphtheria antigens 
included in Tdap. 
 
If Nimenrix is to be given at the same time as another injectable vaccine, the vaccines should always 
be administered at different injection sites. 



31 

 
It may be expected that in patients receiving immunosuppressive treatment, an adequate response may 
not be elicited. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There is limited experience with use of Nimenrix in pregnant women. 
 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, 
embryo/foetal development, parturition or post-natal development (see section 5.3). 
 
Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages 
outweigh the potential risks for the foetus. 
 
Breast-feeding 
 
It is unknown whether Nimenrix is excreted in human milk. 
 
Nimenrix should only be used during breast-feeding when the possible advantages outweigh the 
potential risks. 
 
Fertility 
 
Animal studies do not indicate direct or indirect harmful effects with respect to fertility. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects of Nimenrix on the ability to drive and use machines have been performed. 
However, some of the effects mentioned under section 4.8 “Undesirable effects” may affect the ability 
to drive or use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:  

 A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This 
total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years 
of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 
2,326 adults (18 to 55 years). 

 Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study 
MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 
doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age. 

 
Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was 
administered to 274 individuals aged 56 years and older. 
 
Local and general adverse reactions 
In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 
2 months apart, the first and second doses were associated with similar local and systemic 
reactogenicity. 
 
The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 
12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or 
plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction 



32 

profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms 
(including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age 
and older. 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported 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) 
Very rare: (<1/10,000)  
Not known (cannot be estimated from available data) 
 
Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 
55 years of age and post-marketing experience. Adverse reactions reported in subjects aged >55 years 
were similar to those observed in younger adults.  
 
Table 1:  Tabulated summary of adverse reactions by system organ class 
System Organ Class Frequency Adverse reactions 
Metabolism and nutrition 
disorders 

Very common Appetite lost 

Psychiatric disorders 
 

Very common Irritability
Uncommon Insomnia 

Crying
Nervous system disorders 
 

Very common Drowsiness 
Headache

Uncommon Hypoaesthesia 
Dizziness

Gastrointestinal disorders 
 

Common Diarrhoea 
Vomiting 
Nausea*

Skin and subcutaneous tissue 
disorders 

Uncommon Pruritus 
Rash**

Musculoskeletal and connective 
tissue disorders 

Uncommon Myalgia 
Pain in extremity

General disorders and 
administration site conditions 
 

Very common Fever 
Swelling at injection site 
Pain at injection site 
Redness at injection site 
Fatigue

Common Injection site haematoma* 
Uncommon Malaise 

Injection site induration 
Injection site pruritus 
Injection site warmth 
Injection site anaesthesia

 Not known*** Extensive limb swelling at the injection site, 
frequently associated with erythema, 
sometimes involving the adjacent joint or 
swelling of the entire injected limb 

*Nausea and Injection site haematoma occurred at a frequency of Uncommon in infants 
**Rash occurred at a frequency of Common in infants 
***ADR identified post-marketing 
 



33 

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 
 
No case of overdose has been reported. 
 
 
5.  PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08 
 
Mechanism of action 
 
Anti-capsular meningococcal antibodies protect against meningococcal disease via complement 
mediated bactericidal activity. Nimenrix induces the production of bactericidal antibodies against 
capsular polysaccharides of Neisseria meningitidis groups A, C, W-135 and Y when measured by 
assays using either rSBA or hSBA. 
 
Immunogenicity in infants 
 
In Study MenACWY-TT-083, the first dose was administered at 6 to 12 weeks of age, the second after 
an interval of 2 months, and a third (booster) dose administered at approximately 12 months of age. 
DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine were co-administered. Nimenrix elicited 
rSBA and hSBA titres against the four meningococcal groups as shown in Table 2. The response 
against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines 
in terms of percentages with rSBA titres ≥8 at 1 month after the second dose.  
 
Data from this study support the extrapolation of the immunogenicity data and posology to infants 
from 12 weeks to less than 6 months of age. 
 
Table 2: rSBA and hSBA titres following two doses of Nimenrix (or MenC-CRM or MenC-TT) 

given 2 months apart with the first dose administered to  infants 6-12 weeks of age and 
following a booster at 12 months of age (Study MenACWY-TT-083) 

Meningo-
coccal 
group 

Vaccine 
group 

Time 
point 

rSBA* hSBA** 

N 
8 GMT 

N 
8 GMT 

(95% CI) (95% CI) (95% CI) (95% CI) 

A Nimenrix 

Post-
dose 2(1) 456 

97.4% 
(95.4; 98.6)

203 
(182; 227) 202

96.5%  
(93.0; 98.6) 

157  
(131; 188)

Post-
booster(1)  462 

99.6%  
(98.4; 99.9)

1561  
(1412; 1725) 214

99.5% 
(97.4;100) 

1007 
(836;1214)

C 

Nimenrix 

Post-
dose 2(1) 456 

98.7%  
(97.2; 99.5)

612  
(540; 693) 218

98.6%  
(96.0; 99.7) 

1308  
(1052; 1627)

Post-
booster(1) 463 

99.8%  
(98.8; 100)

1177  
(1059; 1308) 221

99.5%  
(97.5; 100) 

4992  
(4086; 6100)

MenC-
CRM 

vaccine 

Post-
dose 2(1) 455 

99.6%  
(98.4; 99.9)

958  
(850; 1079) 202

100%  
(98.2; 100) 

3188  
(2646; 3841)

Post-
booster(1) 446 

98.4%  
(96.8; 99.4)

1051  
(920; 1202) 216

100%  
(98.3; 100) 

5438  
(4412; 6702)



34 

Table 2: rSBA and hSBA titres following two doses of Nimenrix (or MenC-CRM or MenC-TT) 
given 2 months apart with the first dose administered to  infants 6-12 weeks of age and 
following a booster at 12 months of age (Study MenACWY-TT-083) 

Meningo-
coccal 
group 

Vaccine 
group 

Time 
point 

rSBA* hSBA** 

N 
8 GMT 

N 
8 GMT 

(95% CI) (95% CI) (95% CI) (95% CI) 

MenC-
TT 

vaccine 

Post-
dose 2(1) 457 

100%  
(99.2; 100)

1188  
(1080; 1307) 226

100%  
(98.4; 100) 

2626  
(2219; 3109)

Post-
booster(1) 459 

100%  
(99.2; 100)

1960  
(1776; 2163) 219

100%  
(98.3; 100) 

5542  
(4765; 6446)

W Nimenrix 

Post-
dose 2(1) 455 

99.1%  
(97.8; 99.8)

1605  
(1383; 1862) 217

100%  
(98.3; 100) 

753 
 (644; 882)

Post-
booster(1) 462 

99.8%  
(98.8; 100)

2777  
(2485; 3104) 218

100%  
(98.3; 100) 

5123  
(4504; 5826)

Y Nimenrix 

Post-
dose 2(1) 456 

98.2%  
(96.6; 99.2)

483  
(419; 558) 214

97.7%  
(94.6; 99.2) 

328  
(276; 390)

Post-
booster(1) 462 

99.4%  
(99.1; 99.9)

881  
(787; 986) 217

100% 
(98.3; 100) 

2954  
(2498; 3493)

The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort. 
*rSBA analysis performed at Public Health England (PHE) laboratories in UK 
**hSBA analysis performed at GSK laboratories 
(1) blood sampling performed 21 to 48 days post vaccination 
 
In Study MenACWY-TT-087, infants received either a single primary dose at 6 months followed by a 
booster dose at 15-18 months (DTaP-IPV/Hib and 10-valent pneumococcal conjugate vaccine was 
co-administered at both vaccination time points) or three primary doses at 2, 4, and 6 months followed 
by a booster dose at 15-18 months. A single primary dose administered at 6 months of age elicited 
robust rSBA titres to the four meningococcal groups, as measured by the percentage of subjects with 
rSBA titres ≥8, that were comparable to responses after the last dose of a three-dose primary series. A 
booster dose produced robust responses, comparable between the two dosing groups, against all four 
meningococcal groups. Results are shown in Table 3.  
 
Table 3: rSBA and hSBA titres following a single dose of Nimenrix in infants at 6 months of 

age and pre- and post-booster at 15-18 months of age (Study MenACWY-TT-087) 

Meningo-
coccal 
group  

Time 
point 

rSBA* hSBA** 

N 8 (95% CI) 
GMT 

(95% CI) N 
8 

(95% CI) 
GMT 

(95% CI) 

A 

Post-dose 
1(1) 163 

98.8% 
(95.6; 99.9) 

1333 
(1035; 1716) 59 

98.3% 
(90.9; 100) 

271 
(206; 355) 

Pre-
booster 131 

81.7% 
(74; 87.9) 

125 
(84.4; 186) 71 

66.2% 
(54; 77) 

20.8 
(13.5; 32.2) 

Post-
booster(1)  139 

99.3% 
(96.1; 100) 

2762 
(2310; 3303) 83 

100% 
(95.7; 100) 

1416 
(1140; 1758) 

C 

Post-dose 
1(1) 163 

99.4% 
(96.6; 100) 

592 
(482; 726) 66 

100% 
(94.6;100) 

523 
(382; 717) 

Pre-
booster 131 

65.6% 
(56.9; 73.7) 

27.4 
(20.6; 36.6) 78 

96.2% 
(89.2; 99.2) 

151 
(109; 210) 

Post-
booster(1) 139 

99.3% 
(96.1; 100) 

2525 
(2102; 3033) 92 

100% 
(96.1; 100) 

13360 
(10953; 16296) 



35 

Table 3: rSBA and hSBA titres following a single dose of Nimenrix in infants at 6 months of 
age and pre- and post-booster at 15-18 months of age (Study MenACWY-TT-087) 

Meningo-
coccal 

Time 
point rSBA* hSBA** 

W 

Post-dose 
1(1) 163 

93.9% 
(89; 97) 

1256 
(917; 1720) 47 

87.2% 
(74.3; 95.2) 

137 
(78.4; 238) 

Pre-
booster 131 

77.9% 
(69.8; 84.6) 

63.3 
(45.6; 87.9) 53 

100% 
(93.3; 100) 

429 
(328; 559) 

Post-
booster(1) 139 

100% 
(97.4; 100) 

3145 
(2637; 3750) 59 

100% 
(93.9; 100) 

9016 
(7045; 11537) 

Y 

Post-dose 
1(1) 163 

98.8% 
(95.6; 99.9) 

1470 
(1187; 1821) 52 

92.3% 
(81.5; 97.9) 

195 
(118; 323) 

Pre-
booster 131 

88.5% 
(81.8; 93.4) 

106 
(76.4; 148) 61 

98.4% 
(91.2; 100) 

389 
(292; 518) 

Post-
booster(1) 139 

100% 
(97.4; 100) 

2749 
(2301; 3283) 69 

100% 
(94.8; 100) 

5978 
(4747; 7528) 

The analysis of immunogenicity was conducted on the primary ATP cohort. 
*rSBA analysis performed at PHE laboratories in UK 
**hSBA analysis performed at Neomed in Canada 
(1) blood sampling performed 1 month post vaccination  

 
Measurement of hSBA titres was a secondary endpoint in Study MenACWY-TT-087. Although 
similar responses to groups A and C were observed with both dosing schedules, a single primary dose 
in infants at 6 months was associated with lower hSBA titres to groups W-135 and Y as measured by 
the percentage of subjects with hSBA titres ≥8 [87.2% (95% CI: 74.3, 95.2) and 92.3% (95% CI: 81.5, 
97.9), respectively] compared with three primary doses at 2, 4, and 6 months of age [100% (95% CI: 
96.6, 100) and 100% (95% CI: 97.1, 100), respectively] (see section 4.4). After a booster dose, hSBA 
titres to all four meningococcal groups were comparable between the two dosing schedules. Results 
are shown in Table 3. 
 
Immunogenicity in toddlers aged 12-23 months 
 
In clinical studies MenACWY-TT-039 and MenACWY-TT-040, a single dose of Nimenrix elicited 
SBA titres against the four meningococcal groups, with group C rSBA titres that were comparable to 
those elicited by a licensed MenC-CRM vaccine in terms of the percentage of subjects with rSBA 
titres ≥8. In Study MenACWY-TT-039, hSBA was also measured as a secondary endpoint. Results are 
shown in Table 4. 
 



36 

Table 4: SBA* titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months (Studies MenACWY-TT-039/040) 

Meningo
-coccal 
group 

Vaccine 
group 

Study MenACWY-TT-039(1) Study MenACWY-TT-040(2)
rSBA* hSBA* rSBA* 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI)
GMT 

(95% CI)

A Nimenrix 354 99.7% (98.4; 100) 
2205 

(2008; 2422) 338
77.2% 

(72.4; 81.6)
19.0 

(16.4; 22.1) 183 
98.4% 

(95.3; 99.7)
3170 

(2577; 3899)

C 
Nimenrix 354 99.7% (98.4; 100) 

478 
(437; 522) 341

98.5% 
(96.6; 99.5)

196 
(175; 219) 183 

97.3% 
(93.7; 99.1)

829 
(672; 1021)

MenC-CRM 
vaccine 121 

97.5% 
(92.9; 99.5) 

212 
(170; 265) 116

81.9% 
(73.7; 88.4)

40.3 
(29.5; 55.1) 114 

98.2% 
(93.8; 99.8)

691 
(521; 918)

W-135 Nimenrix 354 100% (99.0; 100) 
2682 

(2453; 2932) 336
87.5% 

(83.5 ; 90.8)
48.9 

(41.2; 58.0) 186 
98.4% 

(95.4; 99.7)
4022 

(3269; 4949)

Y Nimenrix 354 100% (99.0; 100) 
2729 

(2473; 3013) 329
79.3% 

(74.5; 83.6)
30.9 

(25.8; 37.1) 185 
97.3% 

(93.8; 99.1)
3168 

(2522; 3979)
The analysis of immunogenicity was conducted on the ATP cohorts. 
(1) blood sampling performed 42 to 56 days post vaccination 
(2) blood sampling performed 30 to 42 days post vaccination 
* SBA analyses performed at GSK laboratories 
 
In Study MenACWY-TT-104, Nimenrix elicited rSBA titres against all four meningococcal groups 
following one or two doses administered 2 months apart that were similar in terms of the percentage of 
subjects with rSBA titre ≥8 and GMT as shown in Table 5.  
 
Table 5: rSBA and hSBA titres following one or two doses of Nimenrix with the first dose 

administered to toddlers aged 12-14 months (Study MenACWY-TT-104) 
Meningo- 

coccal 
Group 

Nimenrix 
dose 

group 
Time 

point(1) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

A 

1 dose Post dose 1 180 97.8% (94.4; 99.4) 
1437 

(1118; 1847) 74 
95.9% 

(88.6, 99.2) 
118 

(86.8; 161) 

2 doses 
Post dose 1 158 96.8% (92.8; 99.0) 

1275 
(970; 1675) 66 

97.0% 
(89.5; 99.6) 

133 
(98.1; 180) 

Post dose 2 150 98.0% (94.3; 99.6)
1176 

(922; 1501) 66 
97.0% 

(89.5; 99.6) 
170 

(126; 230)

C 

1 dose Post dose 1 179 95.0% (90.7; 97.7) 
452 

(346; 592) 78 
98.7% 

(93.1; 100) 
152 

(105; 220) 

2 doses 
Post dose 1 157 95.5% (91.0; 98.2) 

369 
(281; 485) 70 

95.7% 
(88.0; 99.1) 

161 
(110; 236) 

Post dose 2 150 98.7% (95.3; 99.8)
639 

(522; 783) 69 
100% 

(94.8; 100) 
1753 

(1278; 2404)

W-135 

1 dose Post dose 1 180 95.0% (90.8; 97.7) 
2120 

(1601; 2808) 72 
62.5% 

(50.3; 73.6) 
27.5 

(16.1; 46.8) 

2 doses 
Post dose 1 158 94.9% (90.3; 97.8) 

2030 
(1511; 2728) 61 

68.9% 
(55.7; 80.1) 

26.2 
(16.0; 43.0) 

Post dose 2 150 100% (97.6; 100)
3533 

(2914; 4283) 70 
97.1% 

(90.1; 99.7) 
757 

(550; 1041)



37 

Meningo- 
coccal 
Group 

Nimenrix 
dose 

group 

Time 
point(1) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

Y 

1 dose Post dose 1 180 92.8% (88.0; 96.1) 
952 

(705; 1285) 71 
67.6% 

(55.5; 78.2) 
41.2 

(23.7; 71.5) 

2 doses 
Post dose 1 157 93.6% (88.6; 96.9) 

933 
(692; 1258) 56 

64.3% 
(50.4; 76.6) 

31.9 
(17.6; 57.9) 

Post dose 2 150 99.3% (96.3; 100)
1134 

(944; 1360) 64 
95.3% 

(86.9; 99.0) 
513 

(339; 775)
The analysis of immunogenicity was conducted on the ATP cohort.  
(1) blood sampling performed 21-48 days post vaccination 
*rSBA analysis performed at PHE laboratories 
**hSBA analysis performed at GSK laboratories 
 
In Study MenACWY-TT-104, hSBA titres were measured as a secondary endpoint. Nimenrix elicited 
hSBA titres against groups W-135 and Y that were higher in terms of the percentage of subjects with 
hSBA titre ≥8 when two doses were given compared with one (see section 4.4). Nimenrix elicited 
hSBA titres against groups A and C that were similar in terms of the percentage of subjects with hSBA 
titre ≥8 when two doses were given compared with one. Results are shown in Table 5. 
 
rSBA and hSBA titres were determined over a period of 10 years in children initially vaccinated with 
one dose of Nimenrix or MenC-CRM at 12 to 23 months of age in Study MenACWY-TT-027. 
Persistence of SBA titres was evaluated in two extension studies: MenACWY-TT-032 (up to 5 years) 
and MenACWY-TT-100 (up to 10 years). Study MenACWY-TT-100 also evaluated the response to a 
single booster dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix 
or MenC-CRM. Results are shown in Table 6 (see section 4.4). 
 
Table 6: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 

12-23 months, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo
coccalgro

up 
Vaccine 
Group 

Time point 
 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A Nimenrix 

Month 1(1)  222 100% (98.4; 100)
3707 

(3327; 4129) 217
91.2% 

(86.7; 94.6) 
59.0 

(49.3; 70.6)

Year 4(2)  45 64.4% (48.8; 78.1)
35.1 

(19.4; 63.4) 44 
52.3% 

(36.7; 67.5) 
8.8 

(5.4; 14.2)

Year 5(2) 49 73.5% (58.9; 85.1)
37.4 

(22.1; 63.2) 45 
35.6% 

(21.9: 51.2) 
5.2 

(3.4; 7.8)
Year 10(3)  
 (Pre-booster) 62

66.1% 
(53.0; 77.7)

28.9 
(16.4; 51.0) 59 

25.4% 
(15.0; 38.4) 

4.2 
(3.0; 5.9)

 (Post-booster)(3,4) 62 98.4%  (91.3; 100)
5122 

(3726; 7043) 62 
100% 

(94.2; 100) 
1534 

(1112; 2117)



38 

Table 6: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo
coccalgro

up 
Vaccine 
Group 

Time point 
 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

C 

Nimenrix 

Month 1(1)  220 100% (98.3; 100)
879 

(779; 991) 221
99.1% 

(96.8; 99.9) 
190 

(165; 219)

Year 4(2) 45 97.8% (88.2; 99.9)
110 

(62.7; 192) 45 
97.8% 

(88.2; 99.9) 
370 

(214; 640)

Year 5(2) 49 77.6% (63.4; 88.2)
48.9 

(28.5; 84.0) 48 
91.7% 

(80.0; 97.7) 
216 

(124; 379)
Year 10(3) 
 (Pre-booster) 62

82.3% 
(70.5; 90.8)

128 
(71.1; 231) 60 

91.7% 
(81.6; 97.2) 

349 
(197; 619)

 (Post-booster)(3,4) 62 100% (94.2; 100)
7164 

(5478; 9368) 59 
100% 

(93.9; 100) 
33960 

(23890; 48274)

MenC-
CRM 

vaccine 

Month 1(1)  68 98.5% (92.1; 100)
415 

(297; 580) 68 
72.1% 

(59.9; 82.3) 
21.2 

(13.9; 32.3)

Year 4(2)  10 80.0% (44.4; 97.5)
137 

(22.6; 832) 10 
70.0% 

(34.8; 93.3) 
91.9 

(9.8; 859)

Year 5(2)  11 63.6% (30.8; 89.1)
26.5 

(6.5; 107) 11 
90.9% 

(58.7; 99.8) 
109 

(21.2; 557)
Year 10(3) 
 (Pre-booster) 16

87.5% 
(61.7; 98.4)

86.7  
(29.0; 259) 15 

93.3% 
(68.1; 99.8) 

117 
(40.0; 344)

 (Post-booster)(3,4) 16 100% (79.4; 100)
5793 

(3631; 9242) 15 
100%  

(78.2; 100) 
42559 

(20106; 90086)

W-135 Nimenrix 

Month 1(1)  222 100% (98.4; 100)
5395 

(4870; 5976) 177
79.7% 

(73.0; 85.3) 
38.8 

(29.7; 50.6)

Year 4(2) 45 60.0% (44.3; 74.3)
50.8 

(24.0; 108) 45 
84.4% 

(70.5; 93.5) 
76.9 

(44.0; 134)

Year 5(2) 49 34.7% (21.7; 49.6)
18.2 

(9.3; 35.3) 46 
82.6% 

(68.6; 92.2) 
59.7 

(35.1; 101)
Year 10(3) 
 (Pre-booster) 62

30.6% 
(19.6; 43.7)

15.8 
(9.1; 27.6) 52 

44.2% 
(30.5; 58.7) 

7.7 
(4.9; 12.2)

 (Post-booster)(3,4) 62 100% (94.2; 100)
25911 

(19120; 35115) 62 
100% 

(94.2; 100) 
11925 

(8716; 16316)

Y Nimenrix 

Month 1(1)  222 100% (98.4; 100)
2824 

(2529; 3153) 201
66.7% 

(59.7; 73.1) 
24.4 

(18.6; 32.1)

Year 4(2)  45 62.2% (46.5; 76.2)
44.9 

(22.6; 89.3) 41 
87.8% 

(73.8; 95.9) 
74.6 

(44.5; 125)

Year 5(2)  49 42.9% (28.8; 57.8)
20.6 

(10.9; 39.2) 45 
80.0% 

(65.4; 90.4) 
70.6 

(38.7; 129)
Year 10(3) 
 (Pre-booster) 62

45.2% 
(32.5; 58.3)

27.4 
(14.7; 51.0) 56 

42.9% 
(29.7; 56.8) 

9.1 
(5.5; 15.1)

 (Post-booster)(3,4) 62 98.4% (91.3; 100)
7661  

(5263; 11150) 61 
100% 

(94.1; 100) 
12154 

(9661; 15291)
The analysis of immunogenicity was conducted on the ATP cohorts for 1 month and 5 years post vaccination 
and the booster ATP cohort. Subjects with a suboptimal response to meningococcal group C (defined as SBA 
titre below the pre-defined assay cut-off) were to receive an additional dose of MenC vaccine before Year 6. 
These subjects were excluded from the analysis at Years 4 and 5 but included in the analysis at Year 10. 

(1) Study MenACWY-TT-027 
(2) Study MenACWY-TT-032 
(3) Study MenACWY-TT-100 
(4) Blood sampling was performed 1 month after a booster dose at Year 10.  

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for subsequent sampling time points. 
** hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-TT-
100. 
 



39 

Persistence of booster response 
Study MenACWY-TT-102 evaluated the persistence of SBA titres up to 6 years after a booster dose of 
Nimenrix or MenC-CRM197 administered in Study MenACWY-TT-048 to children who initially 
received the same vaccine at 12 to 23 months of age in Study MenACWY-TT-039. A single booster 
dose was administered 4 years after the initial vaccination. Results are shown in Table 7 
(see section 4.4). 
 

Table 7: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence at 4 years and response following a booster 4 years after initial 
vaccination, and persistence up to 6 years following booster vaccination (Studies MenACWY-
TT-039/048/102) 

Meningo
-coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A Nimenrix 

Month 1(1) 354 99.7% (98.4; 100)
2205 

(2008; 2422) 338
77.2% 

(72.4; 81.6) 
19.0 

(16.4; 22.1)
Year 4(2) 
(Pre-Nimenrix 
booster) 

212 74.5% (68.1; 80.2) 
112 

(80.3; 156) 187
28.9% 

(22.5; 35.9) 4.8 (3.9; 5.9) 

(Post-booster)(2,3) 214 100% (98.3; 100)
7173 

(6389; 8054) 202
99.5% 

(97.3; 100) 
1343 

(1119; 1612)
5 years after 
booster dose(4) 137 

89.8% 
(83.4; 94.3)

229 
(163; 322) 135

53.3% 
(44.6; 62.0) 

13.2 
(9.6; 18.3)

6 years after 
booster dose(4) 134 

92.5% 
(86.7; 96.4)

297 
(214; 413) 130

58.5% 
(49.5; 67.0) 

14.4 
(10.5; 19.7)

C 

Nimenrix 

Month 1(1) 354 99.7% (98.4; 100)
478 

(437; 522) 341
98.5% 

(96.6; 99.5) 
196 

(175; 219)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 39.9% (33.3; 46.8) 
12.1 

(9.6; 15.2) 200
73.0% 

(66.3; 79.0) 
31.2 

(23.0; 42.2) 

(Post-booster)(2,3) 215 100% (98.3; 100)
4512 

(3936; 5172) 209
100%  

(98.3; 100) 
15831 

(13626; 18394)
5 years after 
booster dose(4) 137 

80.3% 
(72.6; 86.6)

66.0 
(48.1; 90.5) 136

99.3% 
(96.0; 100) 

337 
(261; 435)

6 years after 
booster dose(4) 134 

71.6% 
(63.2; 79.1)

39.6 
(28.6; 54.6) 130

97.7% 
(93.4; 99.5) 

259 
(195; 345)

MenC-
CRM 

vaccine 

Month 1(1) 121 97.5% (92.9; 99.5)
212 

(170; 265) 116
81.9% 

(73.7; 88.4) 
40.3 

(29.5; 55.1)
Year 4(2) 
(Pre-MenC-
CRM197 booster) 

43 37.2% (23.0; 53.3) 
14.3 

(7.7; 26.5) 31 
48.4% 

(30.2; 66.9) 
11.9 

(5.1; 27.6) 

(Post-booster)(2,3) 43 100% (91.8; 100)
3718 

(2596; 5326) 33 
100% 

(89.4; 100) 
8646 

(5887; 12699)
5 years after 
booster dose(4) 23 

78.3% 
(56.3; 92.5)

47.3 
(19.0; 118) 23 

100% 
(85.2; 100) 

241 
(139; 420)

6 years after 
booster dose(4) 23 

65.2% 
(42.7; 83.6)

33.0 
(14.7; 74.2) 23 

95.7% 
(78.1; 99.9) 

169 
(94.1; 305)

W-135 Nimenrix 

Month 1(1) 354 100% (99.0; 100)
2682 

(2453; 2932) 336
87.5% 

(83.5; 90.8) 
48.9 

(41.2; 58.0)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 48.8% (41.9; 55.7) 
30.2 

(21.9; 41.5) 158
81.6% 

(74.7; 87.3) 
48.3 

(36.5; 63.9) 

(Post-booster)(2,3) 215 100% (98.3; 100)
10950 

(9531; 12579) 192
100% 

(98.1; 100) 
14411 

(12972; 16010)
5 years after 
booster dose(4) 137 

88.3% 
(81.7; 93.2)

184  
(130; 261) 136

100% 
(97.3; 100) 

327 
(276; 388)

6 years after 
booster dose(4) 134 

85.8% 
(78.7; 91.2)

172 
(118; 251) 133

98.5% 
(94.7; 99.8) 

314 
(255; 388)



40 

Table 7: rSBA and hSBA titres following a single dose of Nimenrix (or MenC-CRM) in toddlers aged 
12-23 months, persistence at 4 years and response following a booster 4 years after initial 
vaccination, and persistence up to 6 years following booster vaccination (Studies MenACWY-
TT-039/048/102) 

Meningo
-coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

Y Nimenrix 

Month 1(1) 354 100% (99.0; 100)
2729 

(2473; 3013) 329
79.3% 

(74.5; 83.6) 
30.9 

(25.8; 37.1)
Year 4(2) 
(Pre-Nimenrix 
booster) 

213 58.2% (51.3; 64.9) 
37.3 

(27.6; 50.4) 123
65.9% 

(56.8; 74.2) 
30.2 

(20.2; 45.0) 

(Post-booster)(2,3) 215 100% (98.3; 100)
4585 

(4129; 5093) 173
100% 

(97.9; 100) 
6776 

(5961; 7701)
5 years after 
booster dose(4) 137 

92.7% 
(87.0; 96.4)

265 
(191; 368) 137

97.8% 
(93.7; 99.5) 

399 
(321; 495)

6 years after 
booster dose(4) 134 

94.0% 
(88.6; 97.4)

260 
(189; 359) 131

97.7% 
(93.5; 99.5) 

316 
(253; 394)

The analysis of immunogenicity was conducted on the ATP cohort for each time point. 
(1) Study MenACWY-TT-039 
(2) Study MenACWY-TT-048 
(3) Blood sampling was performed 1 month after a booster dose at Year 4. 
(4) Study MenACWY-TT-102 

* rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-TT-
102. 
 
Immunogenicity in children aged 2-10 years 
 
In Study MenACWY-TT-081, a single dose of Nimenrix was demonstrated to be non-inferior to 
another licensed MenC-CRM vaccine in terms of vaccine response to group C [94.8% (95% CI: 91.4; 
97.1) and 95.7% (95% CI: 89.2; 98.8), respectively]. The GMT was lower for the Nimenrix group 
[2795 (95% CI: 2393; 3263)] versus the MenC-CRM vaccine [5292 (95% CI: 3815; 7340)]. 
 
In Study MenACWY-TT-038, a single dose of Nimenrix was demonstrated to be non-inferior to the 
licensed ACWY-PS vaccine in terms of vaccine response to the four meningococcal groups as shown 
in Table 8. 
 
Table 8: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in children aged 2-

10 years (Study MenACWY-TT-038) 
Meningo
-coccal 
group 

Nimenrix(1) ACWY-PS vaccine(1) 

N VR (95% CI) 
GMT 

(95% CI) N 
VR 

(95% CI) 
GMT 

(95% CI) 

A 594 89.1% (86.3; 91.5) 
6343 

(5998; 6708) 192 
64.6% 

(57.4; 71.3) 
2283 

(2023; 2577) 

C 691 96.1% (94.4; 97.4) 
4813 

(4342; 5335) 234 
89.7% 

(85.1; 93.3) 
1317 

(1043; 1663) 

W-135 691 97.4% (95.9; 98.4) 
11543 

(10873; 12255) 236 
82.6% 

(77.2; 87.2) 
2158 

(1815; 2565) 

Y 723 92.7% (90.5; 94.5) 
10825 

(10233; 11452) 240 
68.8% 

(62.5; 74.6) 
2613 

(2237; 3052) 
The analysis of immunogenicity was conducted on the ATP cohort . 
(1) Blood sampling performed 1 month post vaccination 
VR: vaccine response defined as the proportion of subjects with: 
 rSBA titres 32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8) 
 at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., 

pre-vaccination rSBA titre ≥8) 
* rSBA analysis performed at GSK laboratories 



41 

 
Persistence of SBA titres was evaluated in children initially vaccinated in Study MenACWY-TT-081 
as shown in Table 9 (see section 4.4). 
 
Table 9: rSBA and hSBA titres up to 44 months following Nimenrix (or MenC-CRM) in 

children aged 2-10 years at time of vaccination (Study MenACWY-TT-088) 
Meningo

coccal 
group 

Vaccine 
group 

Time 
point 

(months) 

rSBA* hSBA** 

N ≥8 (95% CI) 
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI) 

A Nimenrix 
32 193 86.5% (80.9; 91.0)

196 
(144; 267) 90 

25.6% 
(16.9; 35.8) 

4.6 
(3.3; 6.3)

44 189 85.7% (79.9; 90.4)
307 

(224; 423) 89 
25.8% 

(17.1; 36.2) 
4.8 

(3.4; 6.7)

C 

Nimenrix 
32 192 64.6% (57.4; 71.3)

34.8 
(26.0; 46.4) 90 

95.6% 
(89.0; 98.8) 

75.9 
(53.4; 108)

44 189 37.0% (30.1; 44.3)
14.5 

(10.9; 19.2) 82 
76.8% 

(66.2; 85.4) 
36.4 

(23.1; 57.2)

MenC-
CRM 

vaccine 

32 69 76.8% (65.1; 86.1)
86.5 

(47.3; 158) 33 
90.9% 

(75.7; 98.1) 
82.2 

(34.6; 196)

44 66 45.5% (33.1; 58.2)
31.0 

(16.6; 58.0) 31 
64.5% 

(45.4; 80.8) 
38.8 

(13.3; 113)

W-135 Nimenrix 
32 193 77.2% (70.6; 82.9)

214 
(149; 307) 86 

84.9% 
(75.5; 91.7) 

69.9 
(48.2; 101)

44 189 68.3% (61.1; 74.8)
103 

(72.5; 148) 87 
80.5% 

(70.6; 88.2) 
64.3 

(42.7; 96.8)

Y Nimenrix 
32 193 81.3% (75.1; 86.6)

227 
(165; 314) 91 

81.3% 
(71.8; 88.7) 

79.2 
(52.5; 119)

44 189 62.4% (55.1; 69.4)
78.9 

(54.6; 114) 76 
82.9% 

(72.5; 90.6) 
127 

(78.0; 206)
The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time point. 
*rSBA analysis performed at PHE laboratories in UK 
** hSBA analysis performed at GSK laboratories 
 
Persistence of hSBA titres was evaluated 1 year after vaccination in children aged 6-10 years who 
were initially vaccinated in Study MenACWY-TT-027 (Table 10) (see section 4.4). 
 
Table 10: hSBA* titres following a single dose of Nimenrix (or ACWY-PS)  in children aged 

6-10 years and persistence 1 year following vaccination (Studies MenACWY-TT-
027/028) 

Mening
ococcal 
Group 

Vaccine 
group 

1 month post-vaccination 
(Study MenACWY-TT-027) 

1 year persistence 
(Study MenACWY-TT-028) 

N 8 (95% CI) 
GMT 

(95% CI) N 
8 

(95% CI) 
GMT 

(95% CI) 

A 
Nimenrix 105 80.0 % (71.1; 87.2)

53.4 
(37.3; 76.2) 104 

16.3% 
(9.8; 24.9) 

3.5 
(2.7; 4.4)

ACWY-PS 
vaccine 35 

25.7% 
(12.5; 43.3)

4.1 
(2.6; 6.5) 35 

5.7% 
(0.7; 19.2) 

2.5 
(1.9; 3.3)

C 
Nimenrix 101 89.1% (81.3; 94.4)

156 
(99.3; 244) 105 

95.2% 
(89.2; 98.4) 

129 
(95.4; 176)

ACWY-PS 
vaccine 38 

39.5% 
(24.0; 56.6)

13.1 
(5.4; 32.0) 31 

32.3% 
(16.7; 51.4) 

7.7 
(3.5; 17.3)

W-135 
Nimenrix 103 95.1% (89.0; 98.4)

133 
(99.9; 178) 103 

100% 
(96.5; 100) 

257 
(218; 302)

ACWY-PS 
vaccine 35 

34.3% 
(19.1; 52.2)

5.8 
(3.3; 9.9) 31 

12.9% 
(3.6; 29.8) 

3.4 
(2.0; 5.8)



42 

Mening
ococcal 
Group 

Vaccine 
group 

1 month post-vaccination 
(Study MenACWY-TT-027) 

1 year persistence 
(Study MenACWY-TT-028) 

N 8 (95% CI)
GMT 

(95% CI) N 
8 

(95% CI) 
GMT 

(95% CI) 

Y 
Nimenrix 89 83.1% (73.7; 90.2)

95.1 
(62.4; 145) 106 

99.1% 
(94.9; 100) 

265 
(213; 330)

ACWY-PS 
vaccine 32 

43.8% 
(26.4; 62.3)

12.5 
(5.6; 27.7) 36 

33.3% 
(18.6; 51.0) 

9.3 
(4.3; 19.9)

The analysis of immunogenicity was conducted on the ATP cohort for persistence at Year 1. 
hSBA analysis was not performed for children aged 2 to <6 years (at time of vaccination).  
* hSBA analysis performed at GSK laboratories 
 
SBA titres were determined over a period of 10 years in children initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 2 to 10 years of age in Study MenACWY-TT-027. Persistence of SBA 
titres was evaluated in two extension studies: MenACWY-TT-032 (up to 5 years) and MenACWY-
TT-100 (up to 10 years). Study MenACWY-TT-100 also evaluated the response to a single booster 
dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-
PS. Results are shown in Table 11 (see section 4.4). 
 
 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
7301 

(6586; 8093) 111
(5) 81.1% 

(72.5; 87.9) 
57.0 

(40.3; 80.6)

Year 5(2) 98 90.8% (83.3; 95.7)
141 

(98.2; 203) n/a
(6) -- -- 

Year 6(3) 98 79.6% (70.3; 87.1)
107 

(66.0; 174) 90 
41.1% 

(30.8; 52.0) 
6.5 

(4.8; 8.8)
Year 10(3)  
 (Pre-booster) 73 

89.0% 
(79.5; 95.1)

96.3 
(57.1; 163) 62 

33.9% 
(22.3; 47.0) 

4.5 
(3.3; 6.2)

 (Post-booster)(3,4) 74 95.9% (88.6; 99.2)
4626 

(3041; 7039) 73 
100% 

(95.1; 100) 
1213 

(994; 1481)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
2033 

(1667; 2480) 35
(5) 25.7% (12.5; 43.3) 

4.1 
(2.6; 6.5)

Year 5(2) 13 15.4% (1.9; 45.4)
4.7 

(3.7; 6.0) n/a
(6) -- -- 

Year 6(3)  24 12.5% (2.7; 32.4)
5.8 

(3.5; 9.6) 21 
33.3% 

(14.6; 57.0) 
5.9 

(3.0; 11.7)
Year 10(3)  
 (Pre-booster) 17 

23.5% 
(6.8; 49.9)

8.0 
(3.3; 19.3) 17 

29.4% 
(10.3; 56.0) 

6.2  
(2.4; 15.7)

 (Post-booster)(3,4) 17 100% (80.5; 100)
6414 

(3879; 10608) 17 
100% 

(80.5; 100) 
211 

(131; 340)



43 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

C 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
2435 

(2106; 2816) 107
(5) 89.7% 

(82.3; 94.8) 
155 

(101; 237)

Year 5(2) 98 90.8% (83.3; 95.7)
79.7 

(56.0; 113) n/a
(6) -- -- 

Year 6(3)  98 82.7% (73.7; 89.6)
193 

(121; 308) 97 
93.8% 

(87.0; 97.7) 
427 

(261; 700)
Year 10(3)  
 (Pre-booster) 74 

85.1% 
(75.0; 92.3)

181 
(106; 310) 73 

91.8% 
(83.0; 96.9) 

222 
(129; 380)

 (Post-booster)(3,4) 74 100% (95.1; 100)
4020 

(3319; 4869) 71 
100% 

(94.9; 100) 
15544 

(11735; 20588)

ACWY-
PS 

vaccine 

Month 1(1) 74 100% (95.1; 100)
750 

(555; 1014) 38
(5) 39.5% (24.0; 56.6) 

13.1 
(5.4; 32.0)

Year 5(2) 13 100% (75.3; 100)
128 

(56.4; 291) n/a
(6) -- -- 

Year 6(3)  24 79.2% (57.8; 92.9)
98.7 

(42.2; 231) 24 
100% 

(85.8; 100) 
235 

(122; 451)
Year 10(3)  
 (Pre-booster) 17 

76.5% 
(50.1; 93.2)

96.2 
(28.9; 320) 17 

100% 
(80.5; 100) 

99.1 
(35.8; 274)

 (Post-booster)(3,4) 17 100% (80.5; 100)
15101 

(7099; 32122) 17 
94.1 

(71.3; 99.9) 
44794 

(10112; 198440)

W-135 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
11777 

(10666; 13004) 107
(5) 95.3% 

(89.4; 98.5) 
134 

(101; 178)

Year 5(2) 98 78.6% (69.1; 86.2)
209 

(128; 340) n/a
(6) -- -- 

Year 6(3)  98 73.5% (63.6; 81.9)
265 

(155; 454) 92 
81.5% 

(72.1; 88.9) 
62.5 

(42.0; 93.1)
Year 10(3) 
 (Pre-booster) 74 

68.9% 
(57.1; 79.2)

206 
(109; 392) 59 

61.0% 
(47.4; 73.5) 

17.5 
(10.5; 29.2)

 (Post-booster)(3,4) 74 100% (95.1; 100)
27944 

(22214; 35153) 74 
100% 

(95.1; 100) 
6965 

(5274; 9198)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
2186 

(1723; 2774) 35
(5) 34.3% (19.1; 52.2) 

5.8 
(3.3, 9.9)

Year 5(2) 13 0% (0.0; 24.7)
4.0 

(4.0; 4.0) n/a
(6) -- -- 

Year 6(3)  24 12.5% (2.7; 32.4)
7.6 

(3.7; 15.6) 23 
30.4% 

(13.2; 52.9) 
7.0 

(2.9; 16.9)
Year 10(3)  
 (Pre-booster) 17 

23.5% 
(6.8; 49.9)

15.4 
(4.2; 56.4) 15 

26.7% 
(7.8; 55.1) 

4.1 
(2.0; 8.5)

 (Post-booster)(3,4) 17 94.1% (71.3; 99.9)
10463 

(3254; 33646) 15 
100% 

(78.2; 100) 
200 

(101; 395)



44 

Table 11: rSBA and hSBA titres following a single dose of Nimenrix (or ACWY-PS) in children aged 
2-10 years, persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-027/032/100) 

Meningo-
coccal 
group 

Vaccine 
group Time point 

rSBA* hSBA** 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

Y 

Nimenrix 

Month 1(1) 225 100% (98.4; 100)
6641 

(6044; 7297) 94
(5) 83.0% (73.8; 89.9) 

93.7 
(62.1; 141)

Year 5(2) 98 78.6% (69.1; 86.2)
143 

(88.0; 233) n/a
(6) -- -- 

Year 6(3)  98 71.4% (61.4; 80.1)
136 

(82.6; 225) 89 
65.2% 

(54.3; 75.0) 
40.3 

(23.9; 68.1)
Year 10(3)  
 (Pre-booster) 74 

67.6% 
(55.7; 78.0)

98.5 
(54.3; 179) 65 

72.3% 
(59.8; 82.7) 

35.7 
(21.0; 60.6)

 (Post-booster)(3,4) 74 100% (95.1; 100)
7530 

(5828; 9729) 74 
100% 

(95.1; 100) 
11127 

(8909; 13898)

ACWY-
PS 

vaccine 

Month 1(1) 75 100% (95.2; 100)
1410 

(1086; 1831) 32
(5) 43.8% (26.4; 62.3) 

12.5 
(5.6; 27.7)

Year 5(2) 13 7.7% (0.2; 36.0)
5.5 

(2.7; 11.1) n/a
(6) -- -- 

Year 6(3)  24 20.8% (7.1; 42.2)
11.6 

(4.7; 28.7) 24 
25.0% 

(9.8; 46.7) 
7.3 

(2.7; 19.8)
Year 10(3)  
 (Pre-booster) 17 

17.6% 
(3.8; 43.4)

10.2 
(3.5; 30.2) 14 

35.7% 
(12.8; 64.9) 

7.8 
(2.5; 24.4)

 (Post-booster)(3,4) 17 100% (80.5; 100)
6959 

(3637; 13317) 17 
100% 

(80.5; 100) 
454 

(215; 960)
The analysis of immunogenicity was conducted on the ATP cohort for each time point. Subjects with a 
suboptimal response to meningococcal group C (defined as SBA titre below the pre-defined assay cut-off) were 
to receive an additional dose of MenC vaccine before Year 6. These subjects were excluded from the analysis at 
Year 5 but included in the analyses at Years 6 and 10. 

(1) Study MenACWY-TT-027 
(2) Study MenACWY-TT-032 
(3) Study MenACWY-TT-100 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 
(5) Includes children aged 6 to <11 years. hSBA analysis was not performed for children aged 2 to <6 years 

(at time of vaccination). 
(6) Per the protocol for Study MenACWY-TT-032, hSBA was not measured for this age group at Year 5. 

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for subsequent sampling time points. 
**hSBA analysis performed at GSK laboratories and at Neomed in Canada for time points in MenACWY-TT-
100. 
 
Immunogenicity in adolescents aged 11-17 years and adults aged ≥ 18 years 
 
In two clinical studies, conducted in adolescents aged 11-17 years (Study MenACWY-TT-036) and in 
adults aged 18-55 years (Study MenACWY-TT-035), either one dose of Nimenrix or one dose of the 
ACWY-PS vaccine was administered. 
 
Nimenrix was demonstrated to be immunologically non-inferior to the ACWY-PS vaccine in terms of 
vaccine response as shown in Table 12. 
 



45 

Table 12: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents aged 
11-17 years and adults aged 18-55 years (Studies MenACWY-TT-035/036) 

Meningo-
coccal 
group 

Vaccine 
group 

Study MenACWY-TT-036 
(11-17 years)(1) 

Study MenACWY-TT-035 
(18-55 years)(1) 

N VR (95% CI) 
GMT 

(95% CI) N 
VR 

(95% CI) 
GMT 

(95% CI) 

A 

Nimenrix 553 85.4% (82.1; 88.2)
5928 

(5557; 6324) 743 
80.1% 

(77.0; 82.9) 
3625 

(3372; 3897)
ACWY-PS 

vaccine 191 
77.5% 

(70.9; 83.2)
2947 

(2612; 3326) 252 
69.8% 

(63.8; 75.4) 
2127 

(1909; 2370)

C 

Nimenrix 642 97.4% (95.8; 98.5)
13110 

(11939; 14395) 849 
91.5% 

(89.4; 93.3) 
8866 

(8011; 9812)
ACWY-PS 

vaccine 211 
96.7% 

(93.3; 98.7)
8222 

(6807; 9930) 288 
92.0% 

(88.3; 94.9) 
7371 

(6297; 8628)

W-135 

Nimenrix 639 96.4% (94.6; 97.7)
8247 

(7639; 8903) 860 
90.2% 

(88.1; 92.1) 
5136 

(4699; 5614)
ACWY-PS 

vaccine 216 
87.5% 

(82.3; 91.6)
2633 

(2299; 3014) 283 
85.5% 

(80.9; 89.4) 
2461 

(2081; 2911)

Y 

Nimenrix 657 93.8% (91.6; 95.5)
14086 

(13168; 15069) 862 
87.0% 

(84.6; 89.2) 
7711 

(7100; 8374)
ACWY-PS 

vaccine 219 
78.5% 

(72.5; 83.8)
5066 

(4463; 5751) 288 
78.8% 

(73.6; 83.4) 
4314 

(3782; 4921)
The analysis of immunogenicity was conducted on the ATP cohorts. 

(1) Blood sampling performed 1 month post vaccination 
VR: vaccine response defined as the proportion of subjects with: 
 rSBA titres 32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8) 
 at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., 

pre-vaccination rSBA titre ≥8) 
*rSBA analysis performed at GSK laboratories 
 
rSBA titres were determined over a period of 10 years in subjects initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 11 to 17 years of age in Study MenACWY-TT-036. Persistence of rSBA 
titres was evaluated in two extension studies: MenACWY-TT-043 (up to 5 years) and MenACWY-
TT-101 (at 10 years). Study MenACWY-TT-101 also evaluated the response to a single booster dose 
of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-PS. 
Results are shown in Table 13. 
 
Table 13: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents aged 

11-17 years,  persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-036/043/101) 

Meningo-
coccal 
group 

Time point 
 

Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Month 1(1) 674 100% (99.5; 100)
5929 

(5557; 6324) 224 
99.6% 

(97.5; 100) 
2947 

(2612; 3326)

Year 3(2) 449 92.9% (90.1; 95.1)
448 

(381; 527) 150 
82.7% 

(75.6; 88.4) 
206 

(147; 288)

Year 5(2) 236 97.5% (94.5; 99.1)
644 

(531; 781) 86 
93.0% 

(85.4; 97.4) 
296 

(202; 433)
Year 10(3)  
 (Pre-booster) 162 

85.2% 
(78.8; 90.3)

248 
(181; 340) 51 

80.4% 
(66.9; 90.2) 

143 
(80.5; 253)

 (Post-booster)(3,4) 162 100% (97.7; 100)
3760 

(3268; 4326) 51 
100% 

(93.0; 100) 
2956 

(2041; 4282)



46 

Table 13: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents aged 
11-17 years,  persistence up to 10 years, and post-booster administered 10 years following 
initial vaccination (Studies MenACWY-TT-036/043/101) 

Meningo-
coccal 
group 

Time point 
 

Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

C 

Month 1(1) 673 100% (99.5; 100)
13110 

(11939; 14395) 224 
100% 

(98.4; 100) 
8222 

(6808; 9930)

Year 3(2) 449 91.1% (88.1; 93.6)
371 

(309; 446) 150 
86.0% 

(79.4; 91.1) 
390 

(262; 580)

Year 5(2) 236 88.6% (83.8; 92.3)
249 

(194; 318) 85 
87.1% 

(78.0; 93.4) 
366 

(224; 599)
Year 10(3)  
 (Pre-booster) 162 

90.1% 
(84.5; 94.2)

244 
(182; 329) 51 

82.4% 
(69.1; 91.6) 

177 
(86.1; 365)

 (Post-booster)(3,4) 162 100% (97.7; 100)
8698 

(7391 10235) 51 
100% 

(93.0; 100) 
3879 

(2715; 5544)

W-135 

Month 1(1) 678 99.9% (99.2; 100)
8247 

(7639; 8903) 224 
100% 

(98.4; 100) 
2633 

(2299; 3014)

Year 3(2) 449 82.0% (78.1; 85.4)
338 

(268; 426) 150 
30.0% 

(22.8; 38.0) 
16.0 

(10.9; 23.6)

Year 5(2) 236 86.0% (80.9; 90.2)
437 

(324; 588) 86 
34.9% 

(24.9; 45.9) 
19.7 

(11.8; 32.9)
Year 10(3)  
 (Pre-booster) 162 

71.6% 
(64.0; 78.4)

146 
(97.6; 217) 51 

43.1% 
(29.3; 57.8) 

16.4 
(9.2; 29.4)

 (Post-booster)(3,4) 162 100% (97.7; 100)
11243 

(9367; 13496) 51 
100% 

(93.0; 100) 
3674 

(2354; 5734)

Y 

Month 1(1) 677 100% (99.5; 100)
14087 

(13168; 15069) 224 
100% 

(98.4; 100) 
5066 

(4463; 5751)

Year 3(2) 449 93.1% (90.3; 95.3)
740 

(620; 884) 150 
58.0% 

(49.7; 66.0) 
69.6 

(44.6; 109)

Year 5(2) 236 96.6% (93.4; 98.5)
1000 

(824; 1214) 86 
66.3% 

(55.3; 76.1) 
125 

(71.2; 219)
Year 10(3)  
 (Pre-booster) 162 

90.7% 
(85.2; 94.7)

447 
(333; 599) 51 

49.0% 
(34.8; 63.4) 

32.9 
(17.1; 63.3)

 (Post-booster)(3,4) 162 100% (97.7; 100)
7585 

(6748; 8525) 51 
98.0% 

(89.6; 100) 
3296 

(1999; 5434)
The analysis of immunogenicity was conducted on the ATP cohort for each time point. 

(1) Study MenACWY-TT-036 
(2) Study MenACWY-TT-043 
(3) Study MenACWY-TT-101 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 

*rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
 
hSBA persistence was evaluated up to 5 years after vaccination in adolescents and adults initially 
vaccinated in Study MenACWY-TT-052 as shown in Table 14 (see section 4.4). 
 



47 

Table 14: hSBA* titres following a single dose of Nimenrix in adolescents and adults aged 
11-25 years and persistence up to 5 years following vaccination (Studies MenACWY-
TT-052/059) 

Meningococcalgroup Time point N 8 (95% CI) GMT (95% CI) 

A 
Month 1(1)  356 82.0% (77.6; 85.9) 58.7 (48.6; 70.9) 
Year 1(2)  350 29.1% (24.4; 34.2) 5.4 (4.5; 6.4) 
Year 5(2) 141 48.9% (40.4; 57.5) 8.9 (6.8; 11.8) 

C 
Month 1(1)  359 96.1% (93.5; 97.9) 532 (424; 668) 
Year 1(2)  336 94.9% (92.0; 97.0) 172 (142; 207) 
Year 5(2) 140 92.9% (87.3; 96.5) 94.6 (65.9; 136) 

W-135 
Month 1(1)  334 91.0% (87.4; 93.9) 117 (96.8; 141) 
Year 1(2)  327 98.5% (96.5; 99.5) 197 (173; 225) 
Year 5(2) 138 87.0% (80.2; 92.1) 103 (76.3; 140) 

Y 
Month 1(1)  364 95.1% (92.3; 97.0) 246 (208; 291) 
Year 1(2)  356 97.8% (95.6; 99.0) 272 (237; 311) 
Year 5(2) 142 94.4% (89.2; 97.5) 225 (174; 290) 

The analysis of immunogenicity was conducted on the ATP cohort for persistence adapted for each time point. 
(1) Study MenACWY-TT-052 
(2) Study MenACWY-TT-059  

*hSBA analysis performed at GSK laboratories 
 
rSBA titres were determined over a period of 10 years in subjects initially vaccinated with one dose of 
Nimenrix or ACWY-PS at 11 to 55 years of age in Study MenACWY-TT-015. Persistence of rSBA 
titres was evaluated in two extension studies: MenACWY-TT-020 (up to 5 years) and MenACWY-
TT-099 (up to 10 years). Study MenACWY-TT-099 also evaluated the response to a single booster 
dose of Nimenrix administered 10 years following the initial vaccination with Nimenrix or ACWY-
PS. Results are shown in Table 15. 
 
Table 15: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents and 

adults aged 11-55 years, persistence up to 10 years, and post-booster administered 
10 years following initial vaccination (Studies MenACWY-TT-015/020/099) 

Meningo-
coccal 
group 

Time point 
Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

A 

Month 1(1) 323 100% (98.9; 100)
4945 

(4452, 5493) 112
100% 

(96.8, 100) 
2190 

(1858, 2582)

Year 4(2) 43 95.3% (84.2; 99.4)
365 

(226; 590) 17 
76.5% 

(50.1; 93.2) 
104 

(31.0; 351)

Year 5(2) 51 84.3% (71.4; 93.0)
190 

(108; 335) 19 
57.9% 

(33.5; 79.7) 
37.0 

(12.6; 109)
Year 10(3) 
 (Pre-booster) 155 

78.1% 
(70.7; 84.3)

154 
(108; 219) 52 

71.2% 
(56.9; 82.9) 

75.1 
(41.4; 136)

 (Post-booster)(3,4) 155 100% (97.6; 100)
4060 

(3384; 4870) 52 
100% 

(93.2; 100) 
3585 

(2751; 4672)

C 

Month 1(1) 341 99.7% (98.4; 100)
10074 

(8700, 11665) 114
100% 

(96.8; 100) 
6546 

(5048; 8488)

Year 4(2) 43 76.7% (61.4; 88.2)
126 

(61.6; 258) 17 
41.2% 

(18.4; 67.1) 
16.7 

(5.7; 48.7)

Year 5(2) 51 72.5% (58.3; 84.1)
78.5 

(41.8; 147) 18 
38.9% 

(17.3; 64.3) 
17.3 

(6.0; 49.7)
Year 10(3) 
 (Pre-booster) 154 

90.9% 
(85.2; 94.9)

193 
(141; 264) 52 

88.5% 
(76.6; 95.6) 

212 
(110; 412)

 (Post-booster)(3,4) 155 100% (97.6; 100)
13824 

(10840; 17629) 52 
98.1% 

(89.7; 100) 
3444 

(1999; 5936)



48 

Table 15: rSBA* titres following a single dose of Nimenrix (or ACWY-PS) in adolescents and 
adults aged 11-55 years, persistence up to 10 years, and post-booster administered 
10 years following initial vaccination (Studies MenACWY-TT-015/020/099) 

Meningo-
coccal 
group 

Time point 
Nimenrix ACWY-PS vaccine 

N ≥8 (95% CI)
GMT 

(95% CI) N 
≥8 

(95% CI) 
GMT 

(95% CI)

W-135 

Month 1(1) 340 99.7% (98.4; 100)
8577 

(7615; 9660) 114
100% 

(96.8; 100) 
2970 

(2439; 3615)

Year 4(2) 43 90.7% (77.9; 97.4)
240 

(128; 450) 17 
17.6% 

(3.8; 43.4) 
8.3 

(3.6; 19.5)

Year 5(2) 51 86.3% (73.7; 94.3)
282 

(146; 543) 19 
31.6% 

(12.6; 56.6) 
15.4 

(5.7; 41.9)
Year 10(3) 
 (Pre-booster) 154 

71.4% 
(63.6; 78.4)

166 
(107; 258) 52 

21.2% 
(11.1; 34.7) 

10.9 
(6.1; 19.3)

 (Post-booster)(3,4) 155 100% (97.6; 100)
23431 

(17351; 31641) 52 
98.1% 

(89.7; 100) 
5793 

(3586; 9357)

Y 

Month 1(1) 340 100% (98.9; 100)
10315 

(9317; 11420) 114
100% 

(96.8; 100) 
4574 

(3864; 5414)

Year 4(2) 43 86.0% (72.1; 94.7)
443 

(230; 853) 17 
47.1% 

(23.0; 72.2) 
30.7 

(9.0; 105)

Year 5(2) 51 92.2% (81.1; 97.8)
770 

(439; 1351) 19 
63.2% 

(38.4; 83.7) 
74.1 

(21.9; 250)
Year 10(3)  
 (Pre-booster) 154 

86.4% 
(79.9; 91.4)

364 
(255; 519) 52 

61.5% 
(47.0; 74.7) 

56.0 
(28.8; 109)

 (Post-booster)(3,4) 155 100% (97.6; 100)
8958 

(7602; 10558) 52 
100% 

(93.2; 100) 
5138 

(3528; 7482)
The analysis of immunogenicity was conducted on the ATP cohorts for 1 month and 5 years post vaccination 
and the booster ATP cohort. 

(1) Study MenACWY-TT-015 
(2) Study MenACWY-TT-020 
(3) Study MenACWY-TT-099 
(4) Blood sampling was performed 1 month after a booster dose at Year 10. 

* rSBA analysis performed at GSK laboratories for 1 month post primary vaccination samples and at PHE 
laboratories in UK for the subsequent sampling time points. 
 
In a separate study (MenACWY-TT-085), a single dose of Nimenrix was administered to 194 
Lebanese adults aged 56 years and older (including 133 aged 56-65 years and 61 aged >65 years). The 
percentage of subjects with rSBA titres (measured at GSK’s laboratories) ≥128 before vaccination 
ranged from 45% (group C) to 62% (group Y). Overall, at 1 month post-vaccination the percentage of 
vaccines with rSBA titres ≥128 ranged from 93% (group C) to 97% (group Y). In the subgroup aged 
>65 years the percentage of vaccines with rSBA titres ≥128 at 1 month post-vaccination ranged from 
90% (group A) to 97% (group Y). 
 
Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against 
Neisseria meningitidis 
 
Nimenrix booster vaccination in subjects previously primed with a monovalent (MenC-CRM) or a 
quadrivalent conjugate meningococcal vaccine (MenACWY-TT) was studied in subjects from 
12 months of age onwards who received a booster vaccination. Robust anamnestic responses to the 
antigen(s) in the priming vaccine were observed (see Tables 6, 7, 11, 13, and 15). 
 
Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against 
Neisseria meningitidis 
 
In Study MenACWY-TT-021 conducted in subjects aged 4.5-34 years, the immunogenicity of 
Nimenrix administered between 30 and 42 months after vaccination with a ACWY-PS vaccine was 
compared to the immunogenicity of Nimenrix administered to age-matched subjects who had not been 
vaccinated with any meningococcal vaccine in the preceding 10 years. An immune response (rSBA 
titre ≥8) was observed against all four meningococcal groups in all subjects regardless of the 



49 

meningococcal vaccine history. The rSBA GMTs were significantly lower in the subjects who had 
received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix, however 100% of subjects 
achieved rSBA titres ≥8 for all four meningococcal groups (A, C, W-135, Y) (see section 4.4). 
 
Children (2-17 years) with anatomical or functional asplenia 
 
Study MenACWY-TT-084 compared immune responses to two doses of Nimenrix given 2 months 
apart between 43 subjects aged 2-17 years with anatomic or functional asplenia subjects and 
43 age-matched subjects with normal splenic function. One month after the first vaccine dose and 
1 month after the second dose similar percentages of subjects in the two groups had rSBA titres ≥8 and 
≥128 and hSBA titres ≥4 and ≥8. 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on local tolerance, acute toxicity, 
repeated dose toxicity, developmental/reproductive toxicity and fertility studies. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: 
 
Sucrose 
Trometamol 
 
Solvent: 
 
Sodium chloride 
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 
 
4 years 
 
After reconstitution: 
 
After reconstitution, the vaccine should be used promptly. Although delay is not recommended, 
stability has been demonstrated for 8 hours at 30°C after reconstitution. If not used within 8 hours, do 
not administer the vaccine. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 



50 

 
6.5 Nature and contents of container 
 
Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in a vial (type I glass) with a 
stopper (butyl rubber). 
Pack size of 50. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for reconstitution of the vaccine with the solvent presented in vials 
 
Nimenrix must be reconstituted by adding the entire contents of the solvent vial to the vial containing 
the powder. 
1. Withdraw the entire contents of the solvent vial and add the solvent to the powder vial. 
2. The mixture should be well shaken until the powder is completely dissolved in the solvent. 
 
The reconstituted vaccine is a clear colourless solution. 
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of physical aspect prior to administration. In the event of either being observed, discard the 
vaccine. 
After reconstitution, the vaccine should be used promptly. 
 
A new needle should be used to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/12/767/008 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 April 2012 
Date of latest renewal: 16 February 2017 
 
 
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. 
 



51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER 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 



52 

 
 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers of the biological active substance 
 
GlaxoSmithKline Biologicals S.A. 
89, rue de l'Institut 
B-1330 Rixensart 
Belgium 
 
Pfizer Ireland Pharmaceuticals 
Grange Castle Business Park 
Clondalkin 
Dublin 22 
Ireland 
 
 
Name and address of the manufacturer responsible for batch release 
 
Pfizer Manufacturing Belgium N.V. 
Rijksweg 12  
B-2870 Puurs  
Belgium 
 
 
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. 
 
 
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: 



53 

 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 in 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 to evaluate immediate and longer term antibody titres elicited by 
one or two doses of Nimenrix administered in children aged 12-23 months. 
The safety and antibody persistence data up to year 5 and the data on 
co-administration of MenACWY-TT with Prevenar 13 will be provided in 
sequential study reports at 1, 3 and 5 years after vaccination. 

 
1 year CSR Q1 2017 
3 year CSR Q1 2019 
5 year CSR Q1 2021 

 



54 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



56 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 
1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 
10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 
10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nimenrix powder and solvent for solution for injection in pre-filled syringe 
Meningococcal group A, C, W-135 and Y conjugate vaccine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After reconstitution, 1 dose (0.5 ml) contains 5 micrograms of Neisseria meningitidis group A, C, W-
135 and Y polysaccharides. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: 
Sucrose 
Trometamol 
Sodium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection in a pre-filled syringe 
 
1 vial: powder 
1 pre-filled syringe: solvent 
1 dose (0.5 ml) 
 
10 vials: powder 
10 pre-filled syringes: solvent 
10 x 1 dose (0.5 ml) 
 
1 vial: powder 
1 pre-filled syringe: solvent 
2 needles 
1 dose (0.5 ml) 
 
10 vials: powder 
10 pre-filled syringes: solvent 
20 needles 
10 x 1 dose (0.5 ml) 
 
 



57 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use. 
Shake well before 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 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light. 
After reconstitution, use promptly. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of in accordance with local regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/12/767/001 – pack of 1 without needle 
EU/1/12/767/002 – pack of 10 without needle 
EU/1/12/767/003 – pack of 1 with 2 needles 
EU/1/12/767/004 – pack of 10 with 20 needles 
 
 



58 

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. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



59 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
50 POWDER VIALS AND 50 SOLVENT VIALS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Nimenrix powder and solvent for solution for injection in vials 
Meningococcal group A, C, W-135 and Y conjugate vaccine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After reconstitution, 1 dose (0.5 ml) contains 5 micrograms of Neisseria meningitidis group A, C, W-
135 and Y polysaccharides. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: 
Sucrose 
Trometamol 
Sodium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection in vials 
50 vials: powder 
50 vials: solvent 
50 x 1 dose (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Intramuscular use. 
Shake well before 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 
 
 



60 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light. 
After reconstitution, use promptly. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of in accordance with local regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/12/767/008 – pack of 50 
 
 
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. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



61 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
PRE-FILLED SYRINGE WITH SOLVENT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Nimenrix 
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 
 
 



62 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
VIAL WITH SOLVENT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Nimenrix 
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 
 
 



63 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
VIAL WITH MEN ACWY CONJUGATE POWDER 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Powder for Nimenrix 
MenACWY Conjugate 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose 
 
 
6. OTHER 
 
 



64 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

B. PACKAGE LEAFLET 
 



65 

Package leaflet: Information for the user 
 

Nimenrix powder and solvent for solution for injection in pre-filled syringe 
 

Meningococcal group A, C, W-135 and Y conjugate vaccine 
 
 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This vaccine has been prescribed for you or your child. Do not pass it on to others. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be 
given to adults and children so you may be reading it for your child. 
 
What is in this leaflet  
1. What Nimenrix is and what it is used for 
2. What you need to know before you receive Nimenrix 
3. How Nimenrix is given 
4. Possible side effects 
5. How to store Nimenrix 
6. Contents of the pack and other information 
 
 
1. What Nimenrix is and what it is used for 
 
What Nimenrix is and what it is used for 
Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called 
“Neisseria meningitidis" types A, C, W-135 and Y. 
“Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as: 
 meningitis - an infection of the tissue that lines the brain and spinal cord. 
 septicaemia - an infection of the blood. 
These infections are passed easily from person to person and can cause death if not treated. 
Nimenrix may be given to adults, adolescents, children and infants over the age of 6 weeks. 
 
How Nimenrix works 
Nimenrix helps your body to produce its own protection (antibodies) against the bacteria. These 
antibodies help protect you against the diseases. 
 
Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, 
C, W-135 and Y. 
 
 
2. What you need to know before you receive Nimenrix 
 
Nimenrix should not be given if: 
 you are allergic to the active substances or any of the other ingredients in this vaccine (listed in 

section 6). 
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the 
face or tongue. See your doctor immediately if you notice any of these. 

If you are not sure, talk to your doctor or nurse before you receive Nimenrix. 
 



66 

Warnings and precautions: 
Check with your doctor or nurse before you receive this vaccine if: 
 you have an infection with a high temperature (over 38°C). If this applies to you, the 

vaccination will not be given until you are feeling better. A minor infection such as a cold 
should not be a problem. However, talk to your doctor or nurse first. 

 you have a bleeding problem or you bruise easily. 
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you receive 
Nimenrix. 
 
Nimenrix may not fully protect everyone who is vaccinated. If you have a weak immune system (such 
as due to HIV infection or medicines that affect the immune system) you may not get a full benefit 
from Nimenrix. 
 
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore 
tell the doctor or nurse if you or your child fainted with a previous injection. 
 
Other medicines and Nimenrix 
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including other 
vaccines and medicines obtained without a prescription. 
 
Nimenrix may not work as well if you are taking medicines that affect your immune system. 
 
In infants, Nimenrix can be given concomitantly with combined diphtheria - tetanus - acellular 
pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated 
poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-IPV/Hib 
vaccine, and with 10-valent pneumococcal conjugate vaccine. 
 
From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: 
hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, 
measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or 
unadjuvanted seasonal influenza vaccine. 
 
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - 
tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, 
inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-
IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 
 
In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus 
vaccine [Types 16, 18] and a combined diphtheria (reduced antigen content), tetanus and acellular 
pertussis vaccine. 
 
Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, 
should be co-administered or Nimenrix should be administered at least one month before the TT 
containing vaccine. 
 
A different injection site will be used for each vaccine. 
 
Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding, you 
must tell your doctor before receiving Nimenrix. 
 
Driving and using machines 
Nimenrix is not likely to affect your ability to drive or use machines. However, do not drive or use any 
machines if you are feeling unwell. 



67 

 
Nimenrix contains sodium 
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How Nimenrix is given 
 
Nimenrix will be given to you by a doctor or nurse. 
Nimenrix is always injected into a muscle, usually in the upper arm or thigh. 
 
Primary immunisation 
 
Infants from 6 weeks to less than 6 months of age  
Two injections given 2 months apart at e.g. 2 and 4 months of age (the first injection may be given 
from the age of 6 weeks). 
 
Infants from 6 months of age, children, adolescents and adults 
One injection. 
 
Booster doses 
 
Infants from 6 weeks to less than 12 months of age:  
One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix. 
 
Previously vaccinated individuals 12 months of age and older:  
Please tell your doctor if you have received a previous injection with another meningococcal vaccine 
than Nimenrix. 
Your doctor will tell you if and when you need an additional dose of Nimenrix, especially if you or 
your child: 

 received your first dose at age 6-14 months and could be at particular risk of infection caused 
by Neisseria meningitidis types W-135 and Y 

 received your dose more than approximately one year ago and could be at risk of infection 
caused by Neisseria meningitidis type A 

 received your first dose at age 12-23 months and could be at particular risk of infection caused 
by Neisseria meningitidis types A, C, W-135 and Y 
 

You will be informed when you or your child should come back for the next injection. If you or your 
child misses a scheduled injection, it is important that you make another appointment. 
 
Make sure you or your child finishes the complete vaccination course. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The 
following side effects may happen with this medicine: 
 
Very common (these may occur with more than 1 in 10 doses of the vaccine): 
 fever 
 tiredness (fatigue) 
 headache 
 feeling drowsy 
 loss of appetite 
 feeling irritable 



68 

 swelling, pain and redness where the injection is given. 
 
Common (these may occur with up to 1 in 10 doses of the vaccine): 
 bruising (haematoma) where the injection is given 
 stomach and digestion problems such as diarrhoea, vomiting and nausea 
 rash (infants). 
 
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): 
 rash 
 crying 
 itching 
 feeling dizzy 
 aching muscles  
 pain in the arms or legs 
 generally feeling unwell  
 difficulty sleeping 
 decreased feeling or sensitivity, especially in the skin 
 reactions where the injection is given such as itching, a feeling of warmth or numbness or a hard 

lump. 
 
Not known: frequency cannot be estimated from the available data 
 injection site swelling and redness; this may affect a large area of the vaccinated limb 
 
Reporting of side effects 
If you 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 Nimenrix 
 
 Keep this medicine out of the sight and reach of children. 
 Do not use this medicine after the expiry date which is stated on the carton. The expiry date 

refers to the last day of that month. 
 Store in a refrigerator (2°C - 8°C). 
 Store in the original package in order to protect from light. 
 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 protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Nimenrix contains 
 The active substances are: 

- After reconstitution, 1 dose (0.5 ml) contains: 
 Neisseria meningitidis group A polysaccharide1 5 micrograms 
 Neisseria meningitidis group C polysaccharide1 5 micrograms 
 Neisseria meningitidis group W-135 polysaccharide1 5 micrograms 
 Neisseria meningitidis group Y polysaccharide1 5 micrograms 
 1conjugated to tetanus toxoid carrier protein 44 micrograms 
 



69 

 The other ingredients are: 
- In the powder: sucrose and trometamol 
- In the solvent: sodium chloride (see section 2 “Nimenrix contains sodium”) and water for 

injections 
 
What Nimenrix looks like and contents of the pack 
Nimenrix is a powder and a solvent for solution for injection. 
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless 
solvent in a pre-filled syringe. 
These must be mixed together before use. The mixed vaccine will appear as a clear colourless 
solution. 
Nimenrix is available in packs of 1 or 10 with or without needles. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder:  
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 

Manufacturer responsible for batch release: 
Pfizer Manufacturing Belgium N.V. 
Rijksweg 12  
B-2870 Puurs  
Belgium 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Luxembourg/Luxemburg 
Pfizer S.A./N.V. 
Tél/Tel: + 32 (0)2 554 62 11 
 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 
 

България 
Пфайзер Люксембург САРЛ, Клон България 
Teл: +359 2 970 4333 
 

Magyarország 
Pfizer Kft 
Tel: +36 1 488 3700 

Česká Republika 
Pfizer, spol. s r.o. 
Tel: +420 283 004 111 
 

Malta 
Vivian Corporation Ltd. 
Tel: + 35621 344610 
 

Danmark 
Pfizer ApS 
Tlf: + 45 44 201 100 
 

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01 

Deutschland 
Pfizer Pharma GmbH 
Tel: + 49 (0)30 550055-51000 
 

Norge 
Pfizer AS 
Tlf: +47 67 526 100 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal 
Tel.: +372 666 7500 
 

Österreich 
Pfizer Corporation Austria Ges.m.b.H 
Tel: + 43 (0)1 521 15-0 
 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 
 

Polska 
Pfizer Polska Sp. z o.o. 
Tel.: +48 22 335 61 00 



70 

España 
Pfizer, S.L. 
Télf:+34914909900 
 

Portugal 
Laboratórios Pfizer, Lda. 
Tel: +351 21 423 5500 

France 
Pfizer 
Tél +33 1 58 07 34 40 
 

România 
Pfizer Romania S.R.L 
Tel: +40 (0) 21 207 28 00 

Hrvatska  
Pfizer Croatia d.o.o. 
Tel: + 385 1 3908 777 
 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0) 1 52 11 400 
 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 
 

Slovenská republika 
Pfizer Luxembourg SARL, 
organizačná zložka 
Tel: + 421 2 3355 5500 

Ísland 
Icepharma hf 
Simi: + 354 540 8000 
 

Suomi/Finland 
Pfizer Oy 
Puh/Tel: +358 (0)9 430 040 

Italia 
Pfizer S.r.l.  
Tel: +39 06 33 18 21 
 

Sverige 
Pfizer AB 
Tel: +46 (0)8 550 520 00 
 

Kύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch)  
Tηλ: +357 22 817690 

United Kingdom 
Pfizer Limited  
Tel: +44 (0) 1304 616161 
 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 
 

 

This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
The vaccine is for intramuscular use only. Do not administer intravascularly, intradermally or 
subcutaneously. 
 
If Nimenrix is co-administered with other vaccines, different injection sites should be used. 
 
Nimenrix should not be mixed with other vaccines. 
 
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe: 
 
Nimenrix must be reconstituted by adding the entire content of the pre-filled syringe of solvent to the 
vial containing the powder. 



71 

To attach the needle to the syringe, refer to the picture. However, the syringe provided with Nimenrix 
might be slightly different (without screw thread) than the syringe described in the picture. In that case 
the needle should be attached without screwing. 
 
 
1. Holding the syringe barrel in one hand 

(avoid holding the syringe plunger), 
unscrew the syringe cap by twisting it anticlockwise. 

 
 
 
 
 
 
2. To attach the needle to the syringe, 
 twist the needle clockwise into the syringe 
 until you feel it lock (See picture). 
 
 
3. Remove the needle protector, which on 

occasion can be a little stiff. 
 
 
 
 
 
 
 
 
4. Add the solvent to the powder. After the addition of the solvent to the powder, the mixture should 

be well shaken until the powder is completely dissolved in the solvent. 
 
The reconstituted vaccine is a clear colourless solution. 
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of physical aspect prior to administration. In the event of either being observed, discard the 
vaccine. 
After reconstitution, the vaccine should be used promptly. 
 
A new needle should be used to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 

Syringe plunger 

Syringe barrel 
Syringe cap 

Needle protector 



72 

 
Package leaflet: Information for the user 

 
Nimenrix powder and solvent for solution for injection in vials 

Meningococcal group A, C, W-135 and Y conjugate vaccine 
 
 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
 Keep this leaflet. You may need to read it again. 
 If you have any further questions, ask your doctor or pharmacist. 
 This vaccine has been prescribed for you or your child. Do not pass it on to others.  
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be 
given to adults and children so you may be reading it for your child. 
 
What is in this leaflet  
1. What Nimenrix is and what it is used for 
2. What you need to know before you receive Nimenrix 
3. How Nimenrix is given 
4. Possible side effects 
5. How to store Nimenrix 
6. Contents of the pack and other information 
 
 
1. What Nimenrix is and what it is used for 
 
What Nimenrix is and what it is used for 
Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called 
“Neisseria meningitidis” types A, C, W-135 and Y. 
“Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as: 
 meningitis - an infection of the tissue that lines the brain and spinal cord. 
 septicaemia - an infection of the blood. 
These infections are passed easily from person to person and can cause death if not treated. 
Nimenrix may be given to adults, adolescents, children and infants over the age of 6 weeks. 
 
How Nimenrix works 
Nimenrix helps your body to produce its own protection (antibodies) against the bacteria. These 
antibodies help protect you against the diseases. 
Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, 
C, W-135 and Y. 
 
 
2. What you need to know before you receive Nimenrix 
 
Nimenrix should not be given if: 
 you are allergic to the active substances or any of the other ingredients in this vaccine (listed in 

section 6). 
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the 
face or tongue. See your doctor immediately if you notice any of these. 

If you are not sure, talk to your doctor or nurse before you receive Nimenrix. 
 



73 

Warnings and precautions: 
Check with your doctor or nurse before you receive this vaccine if: 
 you have an infection with a high temperature (over 38°C). If this applies to you, the 

vaccination will not be given until you are feeling better. A minor infection such as a cold 
should not be a problem. However, talk to your doctor or nurse first. 

 you have a bleeding problem or you bruise easily. 
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you receive 
Nimenrix. 
 
Nimenrix may not fully protect everyone who is vaccinated. If you have a weak immune system (such 
as due to HIV infection or medicines that affect the immune system) you may not get a full benefit 
from Nimenrix. 
 
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore 
tell the doctor or nurse if you or your child fainted with a previous injection. 
 
Other medicines and Nimenrix 
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including other 
vaccines and medicines obtained without a prescription. 
 
Nimenrix may not work as well if you are taking medicines that affect your immune system. 
 
In infants, Nimenrix can be given concomitantly with combined diphtheria - tetanus - acellular 
pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated 
poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-IPV/Hib 
vaccine, and with 10-valent pneumococcal conjugate vaccine. 
 
From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: 
hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, 
measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or 
unadjuvanted seasonal influenza vaccine. 
 
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheria - 
tetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, 
inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBV-
IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 
 
In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus 
vaccine [Types 16, 18] and a combined diphtheria (reduced antigen content), tetanus and acellular 
pertussis vaccine. 
 
Whenever possible, Nimenrix and a TT containing vaccine, such as DTaP-HBV-IPV/Hib vaccine, 
should be co-administered or Nimenrix should be administered at least one month before the TT 
containing vaccine. 
 
A different injection site will be used for each vaccine. 
 
Pregnancy and breast-feeding 
If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding, you 
must tell your doctor before receiving Nimenrix. 
 
Driving and using machines 
Nimenrix is not likely to affect your ability to drive or use machines. However, do not drive or use any 
machines if you are feeling unwell. 
 



74 

Nimenrix contains sodium 
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How Nimenrix is given 
 
Nimenrix will be given to you by a doctor or nurse. 
Nimenrix is always injected into a muscle, usually in the upper arm or thigh. 
 
Primary immunisation 
 
Infants from 6 weeks to less than 6 months of age  
Two injections given 2 months apart at e.g. 2 and 4 months of age (the first injection may be given 
from the age of 6 weeks). 
 
Infants from 6 months of age, children, adolescents and adults 
One injection.  
 
Booster doses 
 
Infants from 6 weeks to less than 12 months of age:  
One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix. 
 
Previously vaccinated individuals 12 months of age and older:  
Please tell your doctor if you have received a previous injection with another meningococcal vaccine 
than Nimenrix. Your doctor will tell you if and when you need an additional dose of Nimenrix, 
especially if you or your child:  

 received your first dose at age 6-14 months and could be at particular risk of infection caused 
by Neisseria meningitidis types W-135 and Y 

 received your dose more than approximately one year ago and could be at risk of infection 
caused by Neisseria meningitidis type A 

 received your first dose at age 12-23 months and could be at particular risk of infection caused 
by Neisseria meningitidis types A, C, W-135 and Y 

 
You will be informed when you or your child should come back for the next injection. If you or your 
child misses a scheduled injection, it is important that you make another appointment. 
Make sure you or your child finishes the complete vaccination course. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. The 
following side effects may happen with this medicine: 
 
Very common (these may occur with more than 1 in 10 doses of the vaccine): 
 fever 
 tiredness (fatigue) 
 headache 
 feeling drowsy 
 loss of appetite 
 feeling irritable 
 swelling, pain and redness where the injection is given. 



75 

 
Common (these may occur with up to 1 in 10 doses of the vaccine): 
 bruising (haematoma) where the injection is given 
 stomach and digestion problems such as diarrhoea, vomiting and nausea. 
 rash (infants). 
 
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): 
 rash 
 crying 
 itching 
 feeling dizzy 
 aching muscles 
 pain in the arms or legs 
 generally feeling unwell 
 difficulty sleeping 
 decreased feeling or sensitivity, especially in the skin 
 reactions where the injection is given such as itching, a feeling of warmth or numbness or a hard 

lump. 
 
Not known: frequency cannot be estimated from the available data 
 injection site swelling and redness; this may affect a large area of the vaccinated limb 
 
Reporting of side effects 
If you 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 Nimenrix 
 
 Keep this medicine out of the sight and reach of children. 
 Do not use this medicine after the expiry date which is stated on the carton. The expiry date 

refers to the last day of that month. 
 Store in a refrigerator (2°C - 8°C). 
 Store in the original package in order to protect from light. 
 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 protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What Nimenrix contains 
 The active substances are: 

- After reconstitution, 1 dose (0.5 ml) contains: 
 Neisseria meningitidis group A polysaccharide1 5 micrograms 
 Neisseria meningitidis group C polysaccharide1 5 micrograms 
 Neisseria meningitidis group W-135 polysaccharide1 5 micrograms 
 Neisseria meningitidis group Y polysaccharide1 5 micrograms 
 1conjugated to tetanus toxoid carrier protein 44 micrograms 
 
 The other ingredients are: 

- In the powder: sucrose and trometamol 
- In the solvent: sodium chloride (see section 2 “Nimenrix contains sodium”) and water for 

injections 



76 

 
What Nimenrix looks like and contents of the pack 
Nimenrix is a powder and a solvent for solution for injection. 
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless 
solvent in a vial. 
These must be mixed together before use. The mixed vaccine will appear as a clear colourless 
solution. 
Nimenrix is available in a pack of 50. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder:  
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 

Manufacturer responsible for batch release: 
Pfizer Manufacturing Belgium N.V. 
Rijksweg 12  
B-2870 Puurs  
Belgium 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

België/Belgique/Belgien 
Luxembourg/Luxemburg 
Pfizer S.A./N.V. 
Tél/Tel: + 32 (0)2 554 62 11 
 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 
 

България 
Пфайзер Люксембург САРЛ, Клон 
България 
Teл: +359 2 970 4333 
 

Magyarország 
Pfizer Kft 
Tel: +36 1 488 3700 

Česká Republika 
Pfizer, spol. s r.o.  
Tel: +420 283 004 111 
 

Malta 
Vivian Corporation Ltd. 
Tel: + 35621 344610 
 

Danmark 
Pfizer ApS 
Tlf: + 45 44 201 100 
 

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01 

Deutschland 
Pfizer Pharma GmbH 
Tel: + 49 (0)30 550055-51000 
 

Norge 
Pfizer AS 
Tlf: +47 67 526 100 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal 
Tel: +372 666 7500 
 

Österreich 
Pfizer Corporation Austria Ges.m.b.H 
Tel: + 43 (0)1 521 15-0 
 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 
 

Polska 
Pfizer Polska Sp. z o.o. 
Tel.: +48 22 335 61 00 

España 
Pfizer, S.L. 
Télf:+34914909900 
 

Portugal 
Laboratórios Pfizer, Lda. 
Tel: +351 21 423 5500 



77 

France 
Pfizer 
Tél +33 1 58 07 34 40 
 

România 
Pfizer Romania S.R.L 
Tel: +40 (0) 21 207 28 00 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: + 385 1 3908 777 
 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0) 1 52 11 400 
 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 
 

Slovenská republika 
Pfizer Luxembourg SARL, 
organizačná zložka 
Tel: + 421 2 3355 5500 

Ísland 
Icepharma hf 
Simi: + 354 540 8000 
 

Suomi/Finland 
Pfizer Oy 
Puh/Tel: +358 (0)9 430 040 

Italia 
Pfizer S.r.l. 
Tel: +39 06 33 18 21 
 

Sverige 
Pfizer AB 
Tel: +46 (0)8 550 520 00 
 

Kύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch)  
Tηλ: +357 22 817690 

United Kingdom 
Pfizer Limited  
Tel: +44 (0) 1304 616161 
 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 
 

 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 
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The following information is intended for healthcare professionals only: 
 
The vaccine is for intramuscular use only. Do not administer intravascularly, intradermally or 
subcutaneously. 
 
If Nimenrix is co-administered with other vaccines, different injection sites should be used. 
 
Nimenrix should not be mixed with other vaccines. 
 
Instructions for reconstitution of the vaccine with the solvent presented in vials: 
 
Nimenrix must be reconstituted by adding the entire contents of the vial of solvent to the vial 
containing the powder.  
1. Withdraw the entire contents of the solvent vial and add the solvent to the powder vial. 
2. The mixture should be well shaken until the powder is completely dissolved in the solvent. 
 
The reconstituted vaccine is a clear colourless solution. 



78 

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or 
variation of physical aspect prior to administration. In the event of either being observed, discard the 
vaccine. 
After reconstitution, the vaccine should be used promptly. 
 
A new needle should be used to administer the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 


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