Consumer medicine information

Nimenrix

Meningococcal polysaccharide conjugate A, C, Y and W-135 vaccine

BRAND INFORMATION

Brand name

Nimenrix

Active ingredient

Meningococcal polysaccharide conjugate A, C, Y and W-135 vaccine

Schedule

SUMMARY CMI

NIMENRIX^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using NIMENRIX?

NIMENRIX is a vaccine used to help prevent meningococcal disease, caused by four types of Neisseria meningitidis bacteria (types A, C, W and Y). NIMENRIX works by causing your body to produce its own protection (or antibodies), against these types of meningococcal bacteria.

For more information, see Section 1. Why am I using NIMENRIX? in the full CMI.

2. What should I know before I use NIMENRIX?

Do not use if you or your child have ever had an allergic reaction to NIMENRIX or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you or your child have had a serious reaction to any vaccine, have fainted with a previous vaccine, have had a vaccine in the last 4 weeks, have any other medical conditions, take any other medicines, or if you are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use NIMENRIX? in the full CMI.

3. What if I am taking other medicines?

Some vaccines or medicines may interfere with NIMENRIX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NIMENRIX?

Your doctor or nurse will give NIMENRIX as an injection. The vaccine is injected into muscle, usually in the thigh for babies from 6 to 12 weeks of age. In children from 12 months of age and adults, NIMENRIX can be injected into the thigh or arm muscle.

More instructions can be found in Section 4. How do I use NIMENRIX? in the full CMI.

5. What should I know while using NIMENRIX?

Things you should do	Remind any doctor or dentist you visit that you are using NIMENRIX. Keep a record of you or your child's vaccinations, and update this after each injection. Keep any follow-up visits with your doctor or clinic.
Things you should not do	If required, ensure you or your child does not miss follow-up doses of NIMENRIX to make sure the vaccine has the best chance of providing protection against meningococcal disease.
Driving or using machines	Be careful driving or operating machinery until you know how NIMENRIX affects you. In some people, vaccination can cause dizziness or lightheadedness.
Drinking alcohol	Be careful when drinking alcohol until you know how NIMENRIX affects you.
Looking after your medicine	NIMENRIX is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store NIMENRIX, keep it in the fridge, stored between 2°C and 8°C.

For more information, see Section 5. What should I know while using NIMENRIX? in the full CMI.

6. Are there any side effects?

NIMENRIX, like all medicines and vaccines, may cause unwanted side effects in some people. Most unwanted side effects with NIMENRIX are mild and clear up within a few days. These effects, as with other vaccines, generally occur around the injection site. Very common side effects include pain, redness or swelling around the injection site, loss of appetite, fever, drowsiness or feeling tired, headache, irritability/fussiness in a child. As with all vaccines given by injection, there is a very small risk of a serious allergic reaction. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

NIMENRIX^®

Active ingredient(s): Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine powder and solvent for solution for injection in pre-filled syringe

Consumer Medicine Information (CMI)

This leaflet provides important information about using NIMENRIX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NIMENRIX.

Where to find information in this leaflet:

1. Why am I using NIMENRIX?
2. What should I know before I use NIMENRIX?
3. What if I am taking other medicines?
4. How do I use NIMENRIX?
5. What should I know while using NIMENRIX?
6. Are there any side effects?
7. Product details

1. Why am I using NIMENRIX?

NIMENRIX is a vaccine used to help prevent meningococcal disease, caused by four types of Neisseria meningitidis bacteria (types A, C, W and Y).

NIMENRIX works by causing your body to produce its own protection (or antibodies), against these types of meningococcal bacteria. NIMENRIX cannot cause meningococcal disease.

The most common types of meningococcal disease are meningitis (infection of a lining around the brain and spinal cord) and septicaemia (blood infection). Neisseria bacteria can less commonly infect the joints, lungs or other organs.

Meningococcal disease is spread by small droplets from the nose, mouth or throat. Meningococcal disease is generally serious and sometimes causes long-term effects (eg deafness, memory problems, loss of fingers or toes), or death.

As with all vaccines, NIMENRIX may not protect all people who are vaccinated.

Also, NIMENRIX does not help to protect against meningococcal disease caused by other types of Neisseria, or meningitis caused by other bacteria or viruses.

NIMENRIX can be used in infants from 6 weeks of age, children and adults and is particularly recommended for:

Travellers to countries where meningococcal A, W or Y disease outbreaks may happen (eg parts of Africa, annual Hajj)
Close contacts of people with meningococcal A, W or Y disease
People with medical conditions that make them more likely to get meningococcal disease (eg. people without a functioning spleen or some people with a poor immune response to infections).

NIMENRIX may also be prescribed for other people or situations.

2. What should I know before I use NIMENRIX?

Warnings

Do not use NIMENRIX if:

You or your child are allergic to NIMENRIX, or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

If you or your child have been given NIMENRIX before and become unwell, tell your doctor or nurse before the vaccine is given.
You or your child have a severe infection with a high temperature. A minor infection, such as a cold, should not be a problem, but talk to your doctor or nurse before having the vaccine.

Check with your doctor if you:

You or your child have had a serious reaction to any vaccine, including:
- an allergic reaction
- difficulty breathing
- swelling of the throat
- fainting or collapse
- shock-like state or being unresponsive
- fits or convulsions
- high temperature (greater than 40°C)
- severe skin reaction at the injection site
- crying or screaming lasting for more than 3 hours, in a child.
You or your child have allergies to:
- any medicines
- any other substances, such as foods, preservatives or dyes.
You or your child fainted with a previous vaccine. Fainting can occur following, or even before any needle injection.
You or your child have these medical conditions:
- low platelets or a bleeding disorder, since bleeding can occur after injection of NIMENRIX.
- you or your child have any condition, treatment or medicines that affect the immune response to infections. You or your child may still have NIMENRIX if your doctor or nurse recommends it, but may not be protected as much as other people.
You or your child have had a vaccine in the last 4 weeks, or have recently taken any medicines, including medicines that don't need a prescription.
Some vaccines may be affected by other vaccines or medicines. Your doctor, pharmacist or nurse will be able to tell you what to do. See Section 3.What if I am taking other medicines? for a list of vaccines that can be given at the same time as NIMENRIX.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of having NIMENRIX during pregnancy or breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some vaccines may be affected by other vaccines or medicines. Your doctor, pharmacist or nurse will be able to tell you what to do.

NIMENRIX can be given at the same time as the following vaccines.

Infants from 6 weeks up to 12 months of age:

Combined diphtheria, tetanus, acellular pertussis (DTaP), hepatitis B, inactivated polio (IPV) and Haemophilus influenzae type b (Hib) vaccines and 10-valent pneumococcal conjugate vaccine.

Children from 12 months of age and adults:

Hepatitis A and hepatitis B; DTaP vaccines, including combination DTaP vaccines with hepatitis B, IPV or Hib; measles-mumps-rubella (MMR) vaccine, including in combination with varicella (MMRV); seasonal flu and 10 or 13-valent pneumococcal conjugate vaccines; human papillomavirus bivalent vaccine (HPV2) and diphtheria toxoid and acellular pertussis vaccine (Tdap) in individuals aged 9 to 25 years.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NIMENRIX.

4. How do I use NIMENRIX?

How is it given

Your doctor or nurse will give NIMENRIX as an injection. The vaccine is injected into muscle, usually in the thigh for babies from 6 to 12 weeks of age.

In children from 12 months of age and adults, NIMENRIX can be injected into the thigh or arm muscle.

When is it given

Infants 6 weeks to less than 6 months of age:

Your baby will receive two doses, normally given at 2 and 4 months old (2 months apart) however the first dose may be given as early as 6 weeks of age. A booster dose is recommended at 12 months of age.

Infants 6 months to less than 12 months of age:

Your baby will receive one dose given from 6 months of age. A booster dose is recommended at 12 months of age, with an interval of at least 2 months after the initial dose.

Children from 12 months of age and adults:

Most people will be given one NIMENRIX injection.

Some people at increased or continued risk of meningococcal infection may be given two initial NIMENRIX injections; NIMENRIX after another meningococcal vaccine; and/or a booster dose of NIMENRIX.

Your doctor will advise if you or your child need more than one NIMENRIX injection.

If you or your child miss a dose

If a dose of NIMENRIX is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

If you use too much NIMENRIX

For information on the management of overdose, contact the Poison Information Centre on 131126.

5. What should I know while using NIMENRIX?

Things you should do

Keep a record of you or your child's vaccinations, and update this after each injection.

Keep any follow-up visits with your doctor or clinic.

Things you should not do

If required, ensure you or your child does not miss follow-up doses of NIMENRIX to make sure the vaccine has the best chance of providing protection against meningococcal disease.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NIMENRIX affects you.

In some people, vaccination can cause dizziness or lightheadedness.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol until you know how NIMENRIX affects you.

Looking after your medicine

NIMENRIX is usually stored in the doctor's surgery or clinic, or at the pharmacy.

However, if you need to store NIMENRIX,

Keep it in the fridge, stored between 2°C and 8°C.
Do NOT freeze NIMENRIX, store it in the bathroom, or leave it in the car.
Store it in the original pack, to protect it from light.
Keep it out of reach of children.

Ask your pharmacist what to do with NIMENRIX that has expired or not been used.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Most unwanted side effects with NIMENRIX are mild and clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

Very common side effects

Very common side effects	What to do
General disorders and administration site conditions: pain, redness or swelling around the injection site loss of appetite fever drowsiness or feeling tired headache irritability/fussiness in a child	Speak to your doctor if you have any of these less serious side effects and they worry you.

Common side effects

Common side effects	What to do
diarrhoea, vomiting or nausea bruising at the injection site rash (in infants)	Speak to your doctor if you have any of these less serious side effects and they worry you.

Uncommon side effects

Uncommon side effects	What to do
warmth, itchiness, lack of sensation, or a hard lump around the injection site dizziness trouble sleeping decreased sensation or itchiness of the skin; rash pain in a muscle, arm or leg feeling unwell crying in a child large swelling of the vaccinated limb associated with redness may occur	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Serious allergic reaction: swelling of limbs, face, eyes, inside of nose, mouth or throat shortness of breath, breathing or swallowing difficulties hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions unusual tiredness or weakness that is sudden and severe.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NIMENRIX contains

Active ingredient (main ingredient)	NIMENRIX contains agents that stimulate an immune response to Neisseria meningitidis types A, C, W and Y.
Other ingredients (inactive ingredients)	The vaccine also contains sucrose and trometamol. The solvent contains sodium chloride (salt) and water for injection.

Do not take this medicine if you are allergic to any of these ingredients.

What NIMENRIX looks like

NIMENRIX comes as a white powder in a vial, together with a pre-filled syringe of diluent. The powder is dissolved in the solvent by the doctor or nurse, just before injection.

Australian Registration Number:

AUST R 199742

Who distributes NIMENRIX

Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number 1800 675 229

This leaflet was prepared in September 2021.

® = Registered Trademark

NIMENRIX^® is a registered trademark of GlaxoSmithKline Biologicals SA, licensed to Pfizer Inc.

Published by MIMS November 2021

BRAND INFORMATION

Brand name

Nimenrix

Active ingredient

Meningococcal polysaccharide conjugate A, C, Y and W-135 vaccine

Schedule

1 Name of Medicine

Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine.

2 Qualitative and Quantitative Composition

Nimenrix powder and solvent for solution for injection in pre-filled syringe.
After reconstitution, 1 dose (0.5 mL) contains:
meningococcal polysaccharide - Group A* 5 micrograms;
meningococcal polysaccharide - Group C* 5 micrograms;
meningococcal polysaccharide - Group W-135* 5 micrograms;
meningococcal polysaccharide - Group Y* 5 micrograms;
*conjugated to tetanus toxoid carrier protein 44 micrograms.
For the full list of excipients, see Section 6.1 List of Excipients.
No preservative or adjuvant is added.

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 6 weeks of age against invasive meningococcal diseases caused by Neisseria meningitidis groups A, C, W-135 and Y.

4.2 Dose and Method of Administration

Nimenrix should be used in accordance with available official recommendations.

Dosage.

See Table 1.

Long-term antibody persistence data following vaccination with Nimenrix are available up to 10 years after vaccination (see Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties).
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 Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties).

Method of administration.

Nimenrix is for single use in one patient only.
Nimenrix is for 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 deltoid muscle. (See Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)

Use and handling.

Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe. Nimenrix must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder.

To attach the needle to the syringe.

1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach a screw-thread needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. A needle without a screw-thread may also be used. In this case, the needle should be attached without screwing.
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. 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.
Any unused product or waste material should be disposed of in accordance with local requirements.

4.3 Contraindications

Nimenrix should not be administered to subjects with hypersensitivity to the active substances or to any of the excipients contained in the vaccine.

4.4 Special Warnings and Precautions for Use

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.

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.
Persons with certain complement deficiencies and persons receiving treatment that inhibits 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.

Special populations.

Limited data are available on the safety and immunogenicity in individuals with increased susceptibility to meningococcal infection due to anatomic or functional asplenia (such as sickle cell disease) (see Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties).

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

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 Pharmacodynamic Properties). The clinical relevance of this observation is unknown. If an infant aged 6 months to less than 12 months is expected to be at immediate risk of invasive meningococcal disease due to exposure to groups W-135 and 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.

At 1 month post vaccination, toddlers aged 12-14 months had similar rabbit complement serum bactericidal assay (rSBA) titres to groups A, C, W-135 and Y following one dose of Nimenrix or two doses of Nimenrix given two months apart. At 1 year post vaccination, the rSBA titres for groups A, C, W-135 and Y were similar in both the one and the two dose groups (see Section 5.1 Pharmacodynamic Properties).
Measured with a serum bactericidal assay using human complement (hSBA), 1 month post vaccination, responses to groups W-135 and Y were lower after a single dose than after 2 doses given two months apart, while responses to groups A and C were similar in the two groups (see Section 5.1 Pharmacodynamic Properties). The clinical relevance of these observations is unknown. If a toddler is expected to be at immediate risk of invasive meningococcal disease due to the 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.
At 1 year post vaccination, the hSBA responses for groups A, C, W-135 and Y were similar in both the one and the two dose groups (see Section 5.1 Pharmacodynamic Properties). 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.

Persistence of antibodies has been evaluated up to 10 years after vaccination. The persistence studies with Nimenrix have shown a waning of serum bactericidal antibody titres against group A when using hSBA (see Section 5.1, Clinical trials). 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 1 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 for all four serogroups. 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 and Y (see Section 5.1 Pharmacodynamic Properties).
Although Nimenrix contains tetanus toxoid, this vaccine does not substitute for tetanus immunisation.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.1 Therapeutic Indications; Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use, Protection against meningococcal disease; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In infants, Nimenrix can be given concomitantly with combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccines (DTaP/IPV/Hib/HepB), as well as 10-valent pneumococcal conjugate vaccine.
From age 1 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.
Nimenrix can also be given concomitantly with combined diphtheria tetanus acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated polio (IPV) or Haemophilus influenzae type b (Hib), such as DTaP-IPV/Hib/HepB vaccine and 13-valent pneumococcal conjugate vaccine in the second year of life.
In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [type 16 and 18] vaccine, recombinant (HPV2).
Safety and immunogenicity of Nimenrix was evaluated when sequentially administered or co-administered with a DTaP-IPV/Hib/HepB vaccine in the second year of life. The administration of Nimenrix 1 month after the DTaP-IPV/Hib/HepB vaccine resulted in lower MenA, MenC and MenW-135 GMTs as measured with rSBA. The 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, and Y). Whenever possible, Nimenrix and a tetanus toxoid (TT) containing vaccine, such as DTaP-IPV/Hib/HepB vaccine, should either be co-administered or Nimenrix should be administered at least 1 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 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 11 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.
As with other vaccines it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Animal studies with Nimenrix do not indicate direct or indirect harmful effects with respect to fertility (see Section 5.3 Preclinical Safety Data).
(Category B2)
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 pregnancy, embryo/ foetal development, parturition or post-natal development (see Section 5.3 Preclinical Safety Data).
Nimenrix should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
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 breastfeeding when the possible advantages outweigh the potential risks.

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.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

The safety of Nimenrix presented in Table 2 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). In a separate study a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
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.

Local and general adverse reactions.

In all age groups, the local adverse reactions of pain, redness and swelling at the injection site were reported at a very common frequency after vaccination.
In the infant and toddler groups, the general adverse reactions of drowsiness, fever, irritability/fussiness and loss of appetite were reported at a very common frequency after vaccination.
In an additional clinical study of age matched subjects who were either healthy or at increased risk of meningococcal disease due to anatomical or functional asplenia (such as sickle cell disease), the safety profile of Nimenrix in at-risk children and adolescents was generally similar to that observed in the non-asplenic population (see Section 5.1 Pharmacodynamic Properties).
In a separate infant study, 554 infants were primed with 1 or 3 doses of Nimenrix and 508 received booster doses in the second year of life. Local and general adverse reactions in this study were similar in frequency to the larger infant study.
In the 12-14 months age group who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity.
The 2-5 year group reported general adverse reactions at a frequency ranging from common (irritability, loss of appetite and fever) to very common (drowsiness).
In the 6-10, 11-17 and ≥ 18 years age groups, the general adverse reactions were reported at a frequency ranging from common (gastrointestinal symptoms and fever) to very common (headache and fatigue).
In a clinical study of 11 to 25 year old subjects co-administered Nimenrix and Tdap or given the vaccines separately, the local reactions (injection site pain, redness, and swelling) and general reactions (fatigue and headache) occurred at a similar frequency in both groups and in the subjects in the pooled analysis (very common). The general reactions gastrointestinal events (nausea, vomiting, diarrhoea, abdominal pain) occurred more frequently (very common) and fever occurred less frequently (common) compared to subjects in the pooled analysis, but occurred at a similar frequency in subjects co-administered the vaccines and subjects given the vaccines separately in the study.
In a clinical study of female subjects 9 to 25 years old, the local reactions (pain, redness, and swelling at the Nimenrix injection site) and general reactions (headache, fever, and fatigue) occurred at a similar frequency in subjects co-administered Nimenrix, Tdap and HPV2 and in subjects given Nimenrix alone, as they did in subjects in the pooled analysis (very common). The general reactions gastrointestinal events (nausea, vomiting, diarrhoea, abdominal pain) and myalgia occurred at a similar frequency in the 2 groups but more frequently than in the pooled analysis (very common), as did the general reaction rash (common).
The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except gastrointestinal symptoms (including diarrhoea, vomiting, and nausea) which ranged from common to very common among subjects 6 years of age and older (versus common after primary vaccination).

Tabulated list of adverse reactions.

Adverse reactions reported are listed according to the following frequency: 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 the available data).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

No cases of overdose have been reported.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Anticapsular 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 serum bactericidal antibody assays (SBA) using either 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 the immune response to capsular polysaccharide from T-cell independent to T-cell dependent.

Clinical trials.

Immunogenicity in infants.

Two clinical studies have been conducted in infants, MenACWY-TT-083 and MenACWY TT-087. In Study MenACWY-TT-083, the immunogenicity of a 2-dose primary vaccination schedule administered at 2 and 4 months of age was evaluated. Routinely used infant vaccines DTaP/IPV/Hib/HepB and a 10-valent pneumococcal vaccine were co-administered. For group C, rSBA and hSBA titres elicited by Nimenrix were compared to a 2-dose priming with licensed monovalent meningococcal conjugate group C vaccines, MenC-CRM and MenC-TT vaccines. Nimenrix elicited rSBA and hSBA titres against the four meningococcal groups. The response against group C was non-inferior to the one elicited by the licensed MenC-CRM and MenC-TT vaccines in terms of the percentage of subjects with rSBA titres ≥ 8 at 1 month after the second dose.
For subjects initially vaccinated in infancy with Nimenrix at 2 and 4 months of age and receiving a Nimenrix booster dose at 12 months of age, the increase in rSBA and hSBA titres 1 month post-booster dose ranged between 15 and 80-fold for all groups (Study MenACWY-TT-083) and more than 99.0% of all infants achieved post-booster titres above 8 for both assays. The observed booster response for group C was similar to that observed in subjects primed and boosted with a monovalent MenC conjugate vaccine (TT or CRM conjugated). Results are shown in Table 3.

In MenACWY-TT-087, infants received either a single primary dose at 6 months followed by a booster dose at 15-18 months or three primary doses at 2, 4, and 6 months followed by a booster dose at 15-18 months. All subjects also received DTPa-IPV/Hib and 10-valent pneumococcal conjugate vaccines at all time points. A single primary dose administered at 6 months of age elicited robust rSBA responses to groups A, C, W-135 and Y, 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 (Table 4).

Serum bactericidal activity was also measured using hSBA as a secondary endpoint. 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 responses 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 Special Warnings and Precautions for Use). After a booster dose, the hSBA titres to all four serogroups were comparable between the two dosing schedules.

Immunogenicity in toddlers aged 12-23 months.

In clinical studies MenACWY-TT-039 and MenACWY-TT-040, the immune response to vaccination with one dose of Nimenrix or a licensed meningococcal C-CRM₁₉₇ conjugate (MenC-CRM) vaccine was evaluated.
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 5.

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. Results are shown in Table 6.

In Study MenACWY-TT-104, hSBA titres were measured as a secondary endpoint. In terms of the percentage of subjects with hSBA titres ≥ 8, at 1 month post vaccination, hSBA titres against groups W-135 and Y were higher after two doses of Nimenrix than after one dose, while the hSBA titres against groups A and C were similar in the two dose groups. At 1 year post vaccination, the percentage of subjects with hSBA titres ≥ 8 for all four meningococcal groups were similar in both the one and two dose groups (Table 6).

Immunogenicity in children aged 2-10 years.

In two comparative studies of non-inferiority conducted in subjects aged 2-10 years, one dose of Nimenrix was compared to either the licensed ACWY-PS vaccine (Study MenACWY-TT-038) or a licensed MenC-CRM vaccine (Study MenACWY-TT-081).
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 7.

In Study MenACWY-TT-081, a single dose of Nimenrix (N=268) was demonstrated to be non-inferior to a licensed MenC-CRM vaccine (N=92) in 2 to 10 year olds in terms of group C vaccine response one month post-vaccination [94.8% (95% CI: 91.4; 97.1) and 95.7% (95% CI: 89.2; 98.8) respectively]. Group C geometric mean titres (GMTs) were lower for the Nimenrix group [2795 (95% CI: 2393; 3263)] versus the MenC-CRM group [5292 (95% CI: 3815; 7340)].

Immunogenicity in adolescents aged 11-17 years and adults aged ≥ 18.

In two clinical studies, one dose of Nimenrix was compared to one dose of ACWY-PS vaccine administered to adolescents aged 11-17 years (Study MenACWY-TT-036) and in adults aged 18-55 years (Study MenACWY-TT-035).
In both adolescents and adults, Nimenrix was demonstrated to be immunologically non-inferior to the ACWY-PS vaccine in terms of vaccine response. The rSBA titres to the four meningococcal groups elicited by Nimenrix were either similar to or higher than those elicited by the ACWY-PS vaccine as shown in Table 8.

Persistence of immune response.

In Study MenACWY-TT-048, the persistence of rSBA and hSBA titres was evaluated up to 4 years after vaccination in toddlers primed in study MenACWY-TT-039. Results are shown in Table 9.

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 10 (see Section 4.4 Special Warnings and Precautions for Use).

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 11 (see Section 4.4 Special Warnings and Precautions for Use).

Persistence of immune response in children aged 2-10 years.

In Study MenACWY-TT-088, the persistence of SBA titres was evaluated up to 68 months after vaccination in children 2-10 years of age initially vaccinated in Study MenACWY-TT-081. Results are shown in Table 12.

Persistence of immune response in children aged 6-10 years at vaccination.

In Study MenACWY-TT-028, the persistence of hSBA titres was evaluated 1 year after vaccination in children aged 6-10 years of age who were initially vaccinated with either Nimenrix or ACWY-PS vaccine in Study MenACWY-TT-027. Results are shown in Table 13.

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 14 (see Section 4.4 Special Warnings and Precautions for Use).

Persistence of immune response in adolescents aged 11-17 years at vaccination.

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 15.

Persistence of immune response in adolescents and adults aged 11-25 years at vaccination.

In Study MenACWY-TT-059, hSBA persistence was evaluated up to 5 years after vaccination in adolescents and adults aged 11-25 years initially vaccinated in Study MenACWY-TT-052.
For all meningococcal groups, the persistence of hSBA titres elicited by Nimenrix was similar to or higher than those induced by the licensed quadrivalent meningococcal diphtheria toxoid (DT) conjugate vaccine (ACWY-DT) as shown in Table 16.

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 17.

In a descriptive study conducted in 194 adults aged 56 years and older (Study MenACWY-TT-085), Nimenrix was immunogenic, with a vaccine response rate ≥ 63.4% and with ≥ 97.4% of subjects with rSBA titres ≥ 8 against all four meningococcal groups. Moreover, at least 93.2% of subjects achieved the more conservative threshold of protection of rSBA titres ≥ 128.

Immune memory.

In Study MenACWY-TT-014, the induction of immune memory was assessed 1 month after the administration of a fifth of the dose of ACWY-PS vaccine (10 microgram of each polysaccharide) to children in the third year of life. These children were initially vaccinated in study MenACWY-TT-013 with either Nimenrix or a licensed MenC-CRM vaccine at the age of 12 to 14 months.
One month after the challenge dose, the GMTs elicited by the initial vaccination with Nimenrix increased 6.5 to 8-fold, indicating that Nimenrix induces immune memory to all four groups A, C, W-135 and Y. The post-challenge rSBA-MenC GMT was similar in both study groups, indicating that Nimenrix induces an analogous immune memory to group C as the licensed MenC-CRM vaccine. Results are shown in Table 18.

Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against Neisseria meningitidis.

Nimenrix booster vaccination in subjects previously primed with a monovalent conjugate (MenC-CRM) or a quadrivalent polysaccharide (ACWY-PS) 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 11, 12, 15, 16, and 17).

Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide meningococcal 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. The rSBA GMTs were significantly lower in the subjects who had received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix. The clinical relevance of this observation is unknown since all subjects achieved rSBA titres ≥ 8 for all four meningococcal groups regardless of meningococcal vaccination history. Results are shown in Table 19.

Response to Nimenrix in subjects at increased risk for meningococcal infections.

Study MenACWY-TT-084 evaluated the immunogenicity of one and two doses of Nimenrix given 2 months apart in 43 at-risk subjects aged 2-17 years (at increased risk for meningococcal disease, i.e. asplenic subjects, and hyposplenic subjects) compared to 43 healthy age matched subjects.
One month after the first vaccine dose, vaccine response rates (rSBA titre ≥ 1:32 or a ≥ 4 fold increase in rSBA titre from baseline) for groups A, C, W-135, and Y, respectively, were 100%, 92.5%, 100% and 97.5% in the at-risk group and were 97.5%, 97.5%, 97.5%, and 100% for healthy subjects. After the second vaccine dose, vaccine response rates in both at risk and healthy subjects were 100% for each of the four meningococcal groups.

Impact of a single dose of Nimenrix.

In response to an outbreak of meningococcal group W disease, the Netherlands introduced Nimenrix into the national immunisation program in 2018 as a single dose at 14 months of age. A catch-up campaign for individuals 14-18 years of age initiated in 2018 and in 2020 a single dose of Nimenrix at 14 years of age became routine, resulting in a toddler and adolescent national immunisation program. Within two years, the incidence of meningococcal disease caused by groups C, W, and Y had fallen by 100% (95% CI: 14, 100) in individuals 14-18 years of age, 85% (95% CI: 32, 97) in all vaccine eligible ages (direct effect), and 50% (95% CI: 28, 65) in non-vaccine eligible ages (potential indirect effect). The falls in incidence primarily reflected a reduction in group W disease. In children 15 to 36 months, there were only 3 cases during the pre-vaccination period and 2 cases in the post-vaccination period, resulting in an IRR of 33% (95% CI: -302, 89). The low number of cases among this age group does not allow for a reliable assessment of vaccine impact as indicated by the wide 95% CIs.

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.

Genotoxicity.

No data available.

Carcinogenicity.

The carcinogenic potential of Nimenrix has not been investigated.

6 Pharmaceutical Particulars

6.1 List of Excipients

Powder.

Sucrose, trometamol.

Solvent.

0.9% 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

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

After reconstitution.

After reconstitution, the vaccine should be used immediately. For shelf life after reconstitution of the medicinal product, see Section 4.2, Use and handling.

6.4 Special Precautions for Storage

Nimenrix must be stored between +2°C to +8°C. The sterile 0.9% saline diluent may be refrigerated or stored at ambient temperatures, but must not be frozen. The vaccine should be stored in the original package in order to protect from light.

6.5 Nature and Contents of Container

Nimenrix is supplied in a single dose as a white lyophilised powder in a glass vial (type 1 glass) with a stopper (butyl rubber), together with 0.5 mL solvent in a pre-filled syringe with a stopper (butyl rubber).
Pack sizes of 1 and 10 without separate needles.
Not all pack sizes or presentations may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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Nimenrix

Meningococcal polysaccharide conjugate A, C, Y and W-135 vaccine

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