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NIMENRIX (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine)

Health Professional Information

SUMMARY PRODUCT INFORMATION

 

1conjugated to tetanus toxoid carrier protein 44 micrograms

Route of Administration

Dosage Form / Strength

Clinically Relevant Nonmedicinal Ingredients

Intramuscular Injection

Powder and diluent for solution for injection

Neisseria meningitidis serogroup A polysaccharide1
5 micrograms

Neisseria meningitidis serogroup C polysaccharide1
5 micrograms

Neisseria meningitidis serogroup W-135 polysaccharide1
5 micrograms

Neisseria meningitidis serogroup Y polysaccharide1
5 micrograms

Sucrose

Trometamol

Sodium chloride

For a complete listing see Dosage Forms, Composition and Packaging section.

Description

NIMENRIX (meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) is a tetravalent meningococcal polysaccharide conjugated vaccine consisting of Neisseria meningitidis capsular polysaccharides A, C, W-135 and Y each coupled to tetanus toxoid as a carrier protein. The Neisseria meningitidis serogroups A and C polysaccharides are conjugated with an adipic dihydrazide (AH) spacer and indirectly conjugated to the tetanus toxoid whereas the W-135 and Y polysaccharides are conjugated directly to tetanus toxoid. 

The vaccine does not contain any preservatives or adjuvants.

Indications And Clinical Use

NIMENRIX is indicated for the active immunization of individuals from 6 weeks to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Contraindications

NIMENRIX should not be administered to subjects with known hypersensitivity to any component of the vaccine. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section.

Warnings And Precautions

General

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.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Although NIMENRIX contains tetanus toxoid, this vaccine does not substitute for tetanus immunization.

Intercurrent Illness

As with other vaccines, 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 as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.

Thrombocytopenia and Coagulation Disorders

As with other vaccines administered intramuscularly, 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.

Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by meningococcal polysaccharideserogroups A, C, W-135 and Y even if they develop antibodies following vaccination with NIMENRIX.

Safety and immunogenicity have not been assessed in patients with increased susceptibility to meningococcal infection due to conditions such as terminal complement deficiencies and anatomic or functional asplenia. In these individuals, an adequate immune response may not be elicited.

Protection Against Meningococcal Disease

NIMENRIX will only confer protection against Neisseria meningitidis serogroups A, C, W-135 and Y. The vaccine will not protect against other Neisseria meningitidis serogroups.  

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

Immune responses in toddlers aged 12-14 months
At one month post-dose, toddlers aged 12-14 months had similar rabbit complement serum bactericidal assay (rSBA) responses to groups A, C, W-135 and Y following one dose of NIMENRIX or two doses of NIMENRIX given two months apart.

A single dose was associated with lower human complement serum bactericidal assay (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 CLINICAL TRIALS - Immunogenicity in toddlers aged 12-23 months). 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 Y, consideration may be given to administering a second dose after an interval of 2 months. Regarding waning of antibody against MenA or MenC after a first dose of NIMENRIX in children aged 12-23 months, see WARNINGS AND PRECAUTIONS - Persistence of serum bactericidal antibody titres.

Persistence of serum bactericidal antibody titres
Persistence of antibodies has been evaluated up to 5 years after vaccination. The persistence studies with NIMENRIX have shown a waning of serum bactericidal antibody titres against MenA when using human complement in the assay (hSBA) (see CLINICAL TRIALS – Persistence of Immune Response). The clinical relevance of the waning of hSBA MenA antibody titres is unknown. Currently there is limited information available on the safety of a booster dose. However, if an individual is expected to be at particular risk of exposure to MenA and received a dose of NIMENRIX more than approximately one year previously, consideration may be given to administering a booster dose.

Similar to the monovalent Men C comparator, a decline in antibody titres over time has been observed. The clinical relevance of the waning antibody titres 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 and Y (see CLINICAL TRIALS – Booster Response).

Special Populations

Pregnant Women:  There is limited experience with use of NIMENRIX in pregnant women.

Animal studies with NIMENRIX do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo/fetal development, parturition or post-natal development (see TOXICOLOGY).

NIMENRIX should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the fetus.

Nursing Women:  The safety of NIMENRIX when administered to breastfeeding women has not been evaluated. It is unknown whether NIMENRIX is excreted in human breast milk.

NIMENRIX should only be used during breast-feeding when the possible advantages outweigh the potential risks.

Adverse Reactions

Adverse Drug Reaction Overview

The safety profile is based on two data sets:

  • A pooled analysis on 9,621 subjects who have been vaccinated with one dose of NIMENRIX in clinical studies. The pooled analysis includes data for 3,079 toddlers 12 months to 23 months), 1,899 children (2 to 10 years), 2,317 adolescents (11 to 17 years) and 2,326 adults (18 – 55 years). In addition, a descriptive study provides safety data from 274 individuals aged 56 years and older and who have been vaccinated with one dose of NIMENRIX.
  • Data from approximately 1000 infants (6 weeks to 12 months of age) who have been primed and boosted with NIMENRIX.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Solicited Adverse Reactions:

Infants 6 weeks to 12 months old
In Study MenACWY-TT-083, healthy infants received a primary series of 2 doses (at 2 and 4 months of age) of NIMENRIX or control vaccine (meningococcal group C CRM197-conjugate vaccine [MenC-CRM] or meningococcal group C tetanus toxoid conjugate vaccine [MenC-TT]), with the first dose administered between 6 and 12 weeks of age, followed by a booster dose at 12 months of age. Routinely used infant vaccines DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine (PCV10) were coadministered. Table 1 presents the rates of solicited symptoms reported during the 4-day post-vaccination period.

Table 1 Study MenACWY-TT-083: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Primary and Booster Total Vaccinated cohorts)
 

N= number of subjects with at least one documented dose. Doses 1 and 2 given at 2 and 4 months of age, respectively. Booster dose given at 12 months of age.

 

%= percentage of subjects reporting the symptom at least once

 

*Incidence of general symptoms reported for meningococcal vaccine (NIMENRIX, MenC-CRM or MenC-TT) coadministered with DTaP-HBV-IPV-Hib and PCV10

Type

NIMENRIX

MenC-CRM

MenC-TT

Dose 1

N=523

Dose 2

N=516

Booster

N=510

Dose 1

N=509

Dose 2

N=507

Booster

N=496

Dose 1

N=517

Dose 2

N=508

Booster

N=503

Local Symptoms, %

Pain

All

29.6

24.0

39.8

31.0

25.4

40.9

30.4

28.1

36.0

Grade 3

3.3

2.1

4.5

2.4

1.8

6.3

4.6

2.4

3.6

Redness

All

24.5

32.6

43.3

27.1

42.2

42.9

27.1

38.8

45.3

> 30 mm

0.2

0.0

1.2

0.4

0.0

1.0

0.2

0.2

0.8

Swelling

All

11.9

22.3

29.8

17.1

27.0

31.7

15.7

25.6

32.4

> 30 mm

0.0

0.2

0.4

0.6

0.0

0.4

0.0

0.8

1.0

General Symptoms, %*

Type

NIMENRIX

MenC-CRM

MenC-TT

Dose 1

N=523

Dose 2

N=516

Booster

N=510

Dose 1

N=508

Dose 2

N=505

Booster

N=496

Dose 1

N=517

Dose 2

N=507

Booster

N=504

Drowsiness

All

52.8

36.0

39.2

55.9

38.8

40.3

57.3

37.5

38.5

Grade 3

4.2

1.4

1.8

3.1

2.2

3.6

6.2

2.6

2.6

Irritability

All

62.9

52.3

56.7

68.3

52.9

56.9

68.5

50.7

57.5

Grade 3

7.6

5.4

6.3

7.7

6.3

7.1

9.7

7.5

7.7

Loss of appetite

All

38.4

33.1

36.3

37.4

29.7

38.1

41.4

29.6

37.3

Grade 3

1.9

1.9

3.5

1.6

1.8

3.6

1.4

1.8

4.4

Fever (Rectally)

All (>38oC)

30.6

22.7

32.4

32.9

19.8

35.5

34.6

20.9

31.0

>40oC

0

0.2

0.4

0

0.2

0.4

0

0.2

1.0

Toddlers 12 to 23 months old
In Study MenACWY-TT-039, healthy children 12 through 23 months of age were administered one dose of NIMENRIX either alone or co-administered with a first dose of PRIORIX-TETRA®, 1 dose of PRIORIX-TETRA or 1 dose of a licensed MenC-CRM197 (MenC-CRM) vaccine.

Table 2 presents the rates of solicited symptoms reported during the 4-day post-vaccination period in the Co-administered (Co-ad), NIMENRIX, PRIORIX-TETRA and MenC-CRM groups.

Table 2 Study MenACWY-TT-039: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort)
 

N= number of subjects with the dose documented

 

%= percentage of subjects reporting the symptom at least once

Type

NIMENRIX + PRIORIX-TETRA N=375

NIMENRIX

N=367

PRIORIX-TETRA

N=124

MenC-CRM

N=123

Local Symptoms, %

Pain

All

24.3

29.2

17.7

25.2

Grade 3

0.3

0.8

0.0

0.0

Redness

All

35.5

37.1

38.7

31.7

> 30 mm

1.9

4.4

0.0

0.0

Swelling

All

13.9

18.8

5.6

8.1

> 30 mm

2.4

4.1

0.0

0.0

General Symptoms, %

Type

NIMENRIX + PRIORIX-TETRA N=375

NIMENRIX

N=367

PRIORIX-TETRA

N=124

MenC-CRM

N=124

Drowsiness

All

32.5

28.1

23.4

32.3

Grade 3

0.3

0.0

0.8

0.0

Fever (Rectally)

All (>38oC)

14.9

9.3

11.3

12.9

>40oC

0.0

0.0

0.8

0.0

Irritability

All

50.7

40.9

38.7

43.5

Grade 3

0.8

0.5

1.6

0.0

Loss of appetite

All

28.5

22.9

23.4

26.6

Grade 3

0.3

0.0

0

0.0

Redness was the most frequently reported solicited local symptom in each group after each vaccination (38.7% in the PRIORIX-TETRA group, 35.5% in the Co-ad group and 37.1% in the NIMENRIX group and 31.7% in the MenC-CRM group).

Irritability was the most frequently reported solicited general symptom in the 4 groups (50.7% in the Co-ad group, 40.9% in the NIMENRIX group, 38.7% in the PRIORIX-TETRA group and 43.5% in the MenC-CRM group).

In Study Men ACWY-TT-104, toddlers 12-14 months of age were vaccinated with either a single dose of NIMENRIX or 2 NIMENRIX doses administered 2 months apart. In the group who received 2 doses, the first and second doses were associated with similar local and systemic reactogenicity.

Children (2-10 years old), Adolescents (10-25 years old), and Adults (18-55 years old)

Children (2-5 years old)
In Study MenACWY-TT-081, healthy children aged 2 through 10 years of age were administered 1 dose of NIMENRIX or 1 dose of a licensed MenC-CRM vaccine.

Table 3 presents the percentage of subjects (aged 2 through 5 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MenC-CRM groups.

Table 3 MenACWY-TT-081: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort), subjects 2 through 5 years of age
 

N = number of subjects with the dose documented

 

% = percentage of subjects reporting the symptom at least once

Type

NIMENRIX

N=162

MenC-CRM

N=53

Local Symptoms, %

Pain

All

27.8

28.3

Grade 3

0.0

1.9

Redness

All

35.2

39.6

>30 mm

6.8

15.1

Swelling

All

26.5

24.5

>30 mm

4.3

5.7

General Symptoms, %

Drowsiness

All

14.2

11.3

Grade 3

0.0

1.9

Fever/(Orally)

All (>37.5oC)

5.6

5.7

>39.5oC

0.0

0.0

Irritability

All

15.4

11.3

Grade 3

0.6

1.9

Loss of Appetite

All

10.5

9.4

Grade 3

0.0

0.0

Redness was the most frequently reported solicited local symptom in each group (35.2% and 39.6% of the subjects in the NIMENRIX group and MenC-CRM group, respectively).

Irritability was the most frequently reported solicited general symptom in each group (15.4% and 11.3% of the subjects in the NIMENRIX group and MenC-CRM group, respectively). Drowsiness was also reported by 11.3% of the subjects in the MenC-CRM group, as compared to 14.2% of the subjects in the NIMENRIX group. Fever ≥ 37.5°C was reported by 5.6% of the subjects in the NIMENRIX group and 5.7% of the subjects in the MenC-CRM. The majority of fevers were measured by the rectal route (66.7% in the NIMENRIX group and 100% in the MenC-CRM group).

Children aged 6-10 years
Table 4 includes the percentage of subjects (aged 6 through 10 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MenC-CRM groups.

Pain was the most frequently reported solicited local symptom in each group (43.9% and 54.0% of the subjects in the NIMENRIX group and MenC-CRM group, respectively).

Fatigue was the most frequently reported solicited general symptom in each group (22.3% and 22.0% of the subjects in the NIMENRIX group and MenC-CRM group, respectively). Fever ≥ 37.5°C was reported in 6.8% of the subjects in the NIMENRIX group and 2.0% of the subjects in the MenC-CRM group.

Adolescents aged 10-25 years
In Study MenACWY-TT-071, healthy subjects aged 10 through 25 years of age were administered 1 dose of NIMENRIX or 1 dose of MENACTRA® (ACWY-DT vaccine).

Table 4 includes the percentage of subjects (aged 10 through 25 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MENACTRA groups.

The most common solicited local symptom during the 4-day post-vaccination period was pain at the injection site, reported by 51.4% and 55.4% of subjects in the NIMENRIX and MENACTRA groups, respectively. A much smaller percentage of these subjects reported pain with grade 3 intensity, ranging between 0.6% and 2.4% across all vaccine groups.

The incidence of redness at the injection site was 25.8% and 20.3% of subjects in the NIMENRIX and MENACTRA groups, respectively. The incidence of swelling was 19.1% and 13.5% of subjects, respectively. The majority of these events were grade 1 in intensity. Grade 3 events of redness (i.e. > 50 mm in diameter) were reported by 3 and 6 subjects in the NIMENRIX and MENACTRA groups, respectively. Grade 3 events of swelling (i.e. > 50 mm in diameter) were reported by 3 subjects each of the two vaccine groups.

The most common solicited general symptom was fatigue with an incidence of 27.3% to 29.2% across the two vaccine groups. Headache was reported by 25.5% to 26.4% and gastrointestinal symptoms by 13.1% to 13.5% of subjects across the two vaccine groups.

Adults aged 18-55 years
In Study MenACWY-TT-035, healthy adults aged 18 through 55 years of age were administered either 1 dose of NIMENRIX, 1 dose of a licensed ACWY-PS (polysaccharide) vaccine, or 1 dose of NIMENRIX co-administered with a licensed influenza vaccine, FLUARIX®.

Table 4 includes the percentage of subjects (aged 18 through 55 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX, ACWY-PS and Co-administered groups.

Pain was the most frequently reported solicited local symptom in each group (19.4% in the NIMENRIX group, 21.9% in the Co-administered group and 13.5% in the ACWY-PS group). Headache was the most frequently reported solicited general symptom in each group (16.3% in the NIMENRIX group, 14.2% in the ACWY-PS group, and 13.3% in the Co-administered group).

Table 4 Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort), subjects 6 through 55 years of age
 

N = number of subjects with the dose documented

 

% = percentage of subjects reporting the symptom at least once

 

Study 081 and Study 071: Fever (>37.5oC) (Orally)

 

Study 035: Fever (>37.5oC) (Axillary)

MenACWY-TT-081

MenACWY-TT-071

MenACWY-TT- 035

Age

6-10 Years old

10-25 Years old

18-55 Years old

Type

NIMENRIX

N=148

MenC

N=50

NIMENRIX

N=329

MENACTRA N=325

NIMENRIX N=927

NIMENRIX + FLUARIX N=105

ACWY-PS

N=310

Local Symptoms, %

Pain

All

43.9

54.0

51.4

55.4

19.4

21.9

13.5

Grade 3

2.0

6.0

2.4

0.6

0.4

1.0

0.3

Redness

All

39.2

38.0

25.8

20.3

8.8

5.7

4.5

>50 mm

6.1

10.0

0.9

1.8

1.3

0.0

0.0

Swelling

All

29.7

30.0

19.1

13.5

7.9

1.0

1.9

>50 mm

2.7

6.0

0.9

0.9

1.1

0.0

0.0

General Symptoms, %

Type

NIMENRIX N=148

MenC

N=50

NIMENRIX

N=329

MENACTRAN=326

NIMENRIX N=927

NIMENRIX + FLUARIX N=105

ACWY-PS

N=310

Fatigue

All

22.3

22.0

29.2

27.3

12.3

9.5

9.7

Grade 3

2.7

0.0

2.7

1.5

0.9

0.0

0.0

Fever

All (>37.5oC)

6.8

2.0

5.2

4.9

4.0

2.9

4.5

>39.5oC

0.0

0.0

0.3

0.0

0.2

0.0

0.6

Gastro-intestinal

All

14.9

8.0

13.1

13.5

4.6

1.9

3.2

Grade 3

0.7

0.0

1.2

1.2

0.2

0.0

0.3

Headache

All

20.3

8.0

26.1

25.5

16.3

13.3

14.2

Grade 3

1.4

0.0

1.5

1.8

1.5

0.0

1.6

Adults aged > 55 years
In a descriptive study a single dose of NIMENRIX was administered to 274 individuals aged 56 years and older. The adverse reactions reported in this study were already observed in younger age groups.

Common and Uncommon Clinical Trial Adverse Drug Reactions:

Additional adverse reactions reported during clinical studies included in the safety pooled analysis:
Common (≥ 1% to < 10%)*: Injection site hematoma, gastrointestinal symptoms (including diarrhea, vomiting and nausea)

Uncommon (≥ 0.1% to < 1%)**: insomnia, crying, hypoesthesia, dizziness, pruritus, rash, myalgia, pain in extremity, malaise, and injection site reaction (including induration, pruritus, warmth, anesthesia).


*
Nausea and injection site hematoma occurred at a frequency of Uncommon in infants.
**
Rash occurred at a frequency of Common in infants. The adverse reactions hypoesthesia, dizziness, pruritus, myalgia and pain in extremity were not reported in the infant clinical study.

Post-Market Adverse Drug Reactions

General disorders and administration site conditions

Unknown: extensive limb swelling at the injection site, frequently associated with erythema, sometimes involving the adjacent joint or swelling of the entire injected limb.

Drug Interactions

Drug Interactions

In infants, NIMENRIX can be given concomitantly with combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type B vaccines, as well as 10-valent pneumococcal conjugate vaccine (PCV10).

From age 1 year and above, NIMENRIX can be given concomitantly with any of the following vaccines: hepatitis A and hepatitis B vaccines (HAV and HBV), measles-mumps-rubella vaccine (MMR), measles-mumps-rubella-varicella vaccine (MMRV), 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.

NIMENRIX can also be given concomitantly with combined diphtheria-tetanus-acellular pertussis vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b, such as DTaP-HBV-IPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine (PCV13) in the second year of life.

Safety and immunogenicity of NIMENRIX was evaluated when sequentially administered or co-administered with a DTaP-HBV-IPV/Hib vaccine in the second year of life. The administration of NIMENRIX one month after the DTaP-HBV-IPV/Hib vaccine resulted in lower MenA, MenC and MenW-135 rSBA Geometric Mean Titres (GMTs). Clinical relevance of this observation is unknown, since at least 99.4% of subjects (N=178) had rSBA titres ≥ 8 for each group (A, C, W-135, Y). Whenever possible, NIMENRIX and a tetanus toxoid (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). Clinical relevance of this observation is unknown. There was no impact of co-administration on the other nine pneumococcal serotypes.

If NIMENRIX is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

Use with systemic immunosuppressive medications

As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment, an adequate response may not be elicited.

Dosage And Administration

Dosing Considerations

NIMENRIX should be used in accordance with available official recommendations.

Recommended Dose and Dosage Adjustment

  1. Infants From 6 to 12 Weeks of Age

    Two-dose primary series
    The recommended immunization series consists of 2 doses (0.5 mL each) given 2 months apart. The doses should be given at 2 and 4 months of age, followed by a booster dose at 12 months of age. The first dose may be given as early as 6 weeks of age (see CLINICAL TRIALS – Immunogenicity: Immunogenicity in infants).

  2. Individuals From 12 Months of Age

    A single 0.5 mL dose should be administered.

NIMENRIX may be given as a booster dose to individuals who have previously received primary vaccination with NIMENRIX or other conjugated or plain polysaccharide meningococcal vaccines (see WARNINGS AND PRECAUTIONS – Protection Against Meningococcal Disease: Persistence of serum bactericidal antibody titres and CLINICAL TRIALS – Immunogenicity: Immunogenicity in toddlers aged 12-23 months).

A second dose of NIMENRIX may be considered appropriate for some individuals (see WARNINGS AND PRECAUTIONS – Protection Against Meningococcal Disease: Persistence of serum bactericidal antibody titres).

Administration

NIMENRIX is for intramuscular injection only.

The injection sites are the anterolateral aspect of the thigh in infants, or the anterolateral aspect of the thigh or deltoid muscle in individuals from 12 months of age (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).

For instructions on reconstitution of the vaccine before administration, see SPECIAL HANDLING INSTRUCTIONS.

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.

Any unused product or waste material should be disposed of in accordance with local requirements.

Overdosage

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Action And Clinical Pharmacology

Mechanism of Action

Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal killing. NIMENRIX induces the production of bactericidal antibodies against capsular polysaccharides of serogroups A, C, W-135 and Y when measured by assays using either rabbit complement (rSBA) or human complement (hSBA). By conjugating capsular polysaccharide to a protein carrier that contains T-cell epitopes, meningococcal conjugate vaccines like NIMENRIX change the nature of immune response to capsular polysaccharide from T-cell independent to T-cell dependent.

Canadian epidemiological data is available on the Public Health Agency of Canada website:  http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php.

Storage And Stability

Store in a refrigerator (2°C – 8°C). The diluent may also be stored at ambient temperature (25°C).

Do not freeze. Protect from light.

For shelf-life after reconstitution of the vaccine, see SPECIAL HANDLING INSTRUCTIONS.

Special Handling Instructions

In the absence of compatibility studies, NIMENRIX must not be mixed with other medicinal products.

Instructions for reconstitution of the vaccine with the diluent presented in pre-filled syringe

NIMENRIX must be reconstituted by adding the entire content of the pre-filled syringe of diluent to the vial containing the powder.

To attach the needle to the syringe, refer to the below drawing.

Note: However, the syringe provided with NIMENRIX might be slightly different (without screw thread) than the syringe described in the drawing. 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 drawing).

  3. Remove the needle protector, which on occasion can be a little stiff.

  4. Add the diluent to the powder. After the addition of the diluent to the powder, the mixture should be well shaken until the powder is completely dissolved in the diluent.

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.

A new needle should be used to administer the vaccine.

Instructions for reconstitution of the vaccine with diluent presented in ampoules

NIMENRIX must be reconstituted by adding the entire content of the ampoule of diluent to the vial containing the powder.

To do so, break the top of the ampoule, draw up the diluent with a syringe and add the diluent to the powder.

The mixture should be well shaken until the powder is completely dissolved in the diluent.

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.

A new needle should be used to administer the vaccine.

Dosage Forms, Composition And Packaging

Dosage Form

NIMENRIX (meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) is supplied as a sterile lyophilized white powder or cake in a single dose vial.

The diluent (sodium chloride and water for injections) is a sterile clear and colourless liquid supplied separately in a prefilled syringe or ampoule*.

*Format not available in Canada.

After reconstitution, NIMENRIX is a clear colourless solution.

Composition

After reconstitution, 1 dose (0.5 mL) contains:

Active Ingredients
Neisseria meningitidis serogroup A polysaccharide1 5 micrograms
Neisseria meningitidis serogroup C polysaccharide1 5 micrograms
Neisseria meningitidis serogroup W-135 polysaccharide1 5 micrograms
Neisseria meningitidis serogroup Y polysaccharide1 5 micrograms
1conjugated to tetanus toxoid carrier protein 44 micrograms

Excipients

Powder:

Sucrose 28 mg
Trometamol 97 mcg

Diluent:

Sodium chloride 4.5 mg
Water for Injections q.s. to 0.5 mL

Packaging

NIMENRIX is supplied in a 3 mL single dose glass vial. The diluent (0.5 mL) is supplied in a prefilled syringe or ampoule*.

The vials, syringes, and ampoules* are made of neutral glass Type 1.

NIMENRIX is available in pack sizes as follows:

  • Single dose vial packaged with pre-filled syringe of diluent with or without needles in pack sizes of 1 and 10.
  • Single dose vial packaged with ampoule* of diluent in pack sizes of 1, 10 or 100.

*Format not available in Canada.

 

Control #: 220188
December 19, 2018

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