Consumer medicine information

NeisVac-C Vaccine

Meningococcal group C polysaccharide conjugate vaccine

BRAND INFORMATION

Brand name

NeisVac-C Vaccine

Active ingredient

Meningococcal group C polysaccharide conjugate vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using NeisVac-C Vaccine.

SUMMARY CMI

NeisVac-C®

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 NeisVac-C?

NeisVac-C is a vaccine used to help prevent invasive meningococcal disease caused by bacteria called Neisseria meningitidis group C for people from 8 weeks of age.

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

2. What should I know before I use NeisVac-C?

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

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

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

3. What if I am taking other medicines?

Some medicines may interfere with NeisVac-C 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 NeisVac-C?

NeisVac-C will be injected into a muscle. It is usually injected into the thigh for infants and into the arm for older children, adolescents, and adults.

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

5. What should I know while using NeisVac-C?

Things you should do
  • Tell your doctor or nurse if you or your child have been given other vaccines.
  • Tell your doctor or nurse if you are pregnant or plan to become pregnant or are breast-feeding.
Things you should not do
  • Vaccination should not be given to an infant under 8 weeks of age.
  • Do not withhold any information from your treating health professional.
Looking after your medicine

If you are required to store Neisvac-C:

  • Keep NeisVac-C stored at 2°C to 8°C (in a refrigerator). Do not freeze.
  • Store it in a cool, dry place away from moisture, heat or sunlight.
  • NeisVac-C can be stored out of the refrigerator, at room temperature up to 25°C, for up to 9 months before the expiry date shown on the pack.

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

6. Are there any side effects?

Common side effects may include pain, redness or swelling at the injection site, nausea, vomiting, diarrhoea, stomach pains or fatigue. More serious side effects may be a severe allergic reaction known as anaphylaxis, neck stiffness or easy bruising and blistering.

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

NeisVac-C®

Active ingredient(s): Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using NeisVac-C. 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 NeisVac-C.

Where to find information in this leaflet:

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

1. Why am I using NeisVac-C?

NeisVac-C is a vaccine, a type of medicine used to help protect against infectious diseases

NeisVac-C is used to prevent invasive disease caused by bacteria calledNeisseria meningitidisgroup C.

The Neisseria meningitidis bacteria can cause serious and sometimes life-threatening infections such as meningitis and septicaemia (blood poisoning). NeisVac-C will only protect against invasive disease (commonly called meningococcal) caused by meningococci group C bacteria. It will not protect against other groups of meningococci or other organisms that cause meningitis and blood poisoning.

When a person is given NeisVac-C, the immune system (the body's natural defence system) will produce its own protection (antibodies) against disease.

Your body usually takes several weeks after vaccination to develop protection against invasive meningococcal disease. Most people will produce enough antibodies to protect them against invasive meningococcal disease. However, as with all vaccines, 100% protection cannot be guaranteed.

NeisVac-C will not give you or your child meningococcal disease.

The chance of a severe reaction from NeisVac-C is very small, but the risks from not being vaccinated against invasive meningococcal disease may be very serious.

NeisVac-C is given to children from 8 weeks of age, adolescents and adults.

2. What should I know before I use NeisVac-C?

Warnings

You or your child should not be given NeisVac-C if:

  1. You are allergic to any of the ingredients listed at the end of this leaflet including tetanus toxoid (TT) or if you or your child have shown an allergic reaction to NeisVac-C when given it previously.
Some of the 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.
Always check the ingredients to make sure you can use this medicine.
  1. It has passed the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
It has expired or is damaged - return it to your pharmacist.
  1. Vaccination should not be given to an infant under 8 weeks of age.

Vaccination should be delayed if you or your child has a moderate or severe fever, or a current or recent medical concern.

If you are not sure whether you or your child should be given NeisVac-C, talk to your doctor or nurse. A minor illness, such as a cold, is not usually a reason to delay vaccination.

Check with your doctor if you or your child have any other medical conditions, including any of the following:

  • blood clotting disorder
  • if you or your child are taking anti-coagulation medicine or undergoing anti-coagulation therapy (as there is a risk of bleeding at the injection site following vaccination)
  • any condition affecting the immune system, such as HIV infection, or if you or your child are undergoing treatment which can alter the effectiveness of your immune system, such as cancer therapy.

Tell your doctor:

  • if you are pregnant or plan to become pregnant or are breastfeeding – see Pregnancy and breastfeeding below.
  • if your baby was born prematurely. There is a higher risk of apnoea (temporarily stopping breathing) for 2-3 days after vaccination of a premature baby. Your doctor may decide if your baby requires monitoring during this time.

NeisVac-C will not cause meningococcal group C infection but some people could already have the disease or have meningitis caused by other organisms, prior to vaccination.

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.

The vaccine should not be used during pregnancy unless there is a defined risk of meningococcal C disease. If there is a need to consider vaccination during pregnancy or breast-feeding, your doctor can discuss with you the risks and benefits involved.

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

Your doctor will advise regarding this vaccine and pregnancy.

3. What if I am taking other medicines?

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

Tell your doctor or nurse if you or your child have been given other vaccines.

  • Your doctor will advise you if you or your child need to have NeisVac-C at the same time as other injected vaccines.
  • NeisVac-C must not be mixed with other vaccines in the same syringe.
  • NeisVac-C may be given at the same time as other vaccines as long as they are given at different places on your body and using separate syringes.
  • Other vaccines that can be given at the same time can protect against:
    - polio
    - measles, mumps, and rubella (German measles) (MMR)
    - diphtheria, tetanus and pertussis (whooping cough)
    - infections caused by Haemophilus influenzae (Hib)
    - Pneumococcal infections.
  • NeisVac-C can be given to infants at the same time as certain types of vaccines that protect against hepatitis B infection. Your doctor will advise you if this is necessary and which vaccine might be suitable.

Immunisation with NeisVac-C is not a substitute for routine tetanus immunisation.

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

4. How do I use NeisVac-C?

How much to be given

The dosage for infants under the age of 12 months is two separate doses, the first dose given not earlier than 8 weeks of age and with an interval of at least two months between doses.

After the infant course of two doses is completed, children should be given a single booster dose in the second year of life. This should help maintain protection. Your doctor will advise you when your child should receive this.

For children 12 months of age and older, and for adolescents and adults, a single dose of the vaccine is recommended.

How NeisVac-C is given

NeisVac-C will be injected into a muscle. It is usually injected into the thigh for infants and into the arm for older children, adolescents, and adults.

The vaccine must not be injected under the skin or into a blood vessel and your doctor or nurse will take care to avoid doing this when administering the vaccine.

If you miss a dose of NeisVac-C vaccination

Your doctor or nurse will inform you about the vaccination schedule to follow. If you or your child miss a recommended dose or stop the vaccination course, this may result in incomplete protection.

If you take too much NeisVac-C

An overdose is highly unlikely, as it is given as a single-dose syringe by a doctor or nurse. If the doses are given closer together than recommended or more doses than required are given, side effects are more likely to occur.

If you think that you have been given too much NeisVac-C, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using NeisVac-C?

Things you should do

Ensure you and your child stay up to date with required vaccinations.

Call your doctor straightaway if you:

  • Notice any symptoms that worry you or may be severe.
  • Develop signs of an allergic reaction such as skin rash, swelling of the lips or tongue, or difficulty breathing.

Things you should not do

Do not withhold any information from your treating health professional.

Looking after your medicine

If you are required to store NeisVac-C:

  • Keep NeisVac-C stored at 2°C to 8°C (in a refrigerator).
    Do not freeze.
  • NeisVac-C can be stored out of the refrigerator, at room temperature up to 25°C, for up to 9 months before the expiry date shown on the pack. Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
    - in the bathroom or near a sink, or
    - in the car or on window sills.
  • When NeisVac-C is stored at room temperature, the initial date i was taken out of the refrigerator must be recorded and the product must not be returned to the refrigerator. At the end of this period, NeisVac-C should be used or returned to a pharmacy.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

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.

Side effects

Side effectsWhat to do
Injection site symptoms
  • redness, swelling, tenderness and pain at the site of injection
Aches and pains
  • pain in the arms and legs or muscle aching or weakness
Gastrointestinal symptoms
  • nausea or vomiting
  • diarrhoea
  • stomach pain
  • loss of appetite
  • indigestion or reflux
Tiredness, alertness, and sleep related symptoms
  • fatigue
  • tiredness or sleepiness
  • generally feeling unwell
  • agitation or restlessness
  • irritability or crying
  • poor sleep
Skin symptoms
  • itchy skin, dermatitis, rash or skin discolouration that resembles bruising
Cold and flu symptoms:
  • fever
  • coughing
  • inflamed throat or a runny or blocked nose
  • chills, swollen glands or flu-like symptoms.
Other side effects
  • increased sweating
  • dizziness
  • headache
  • flushing
  • burning sensation/pins and needles
Speak to your doctor if you have any of these common side effects and they worry you. Seek appropriate medical treatment if any of these symptoms worsen.

Serious side effects

Serious side effectsWhat to do
Severe allergy (anaphylaxis)
  • swelling of the lips, mouth and throat which may cause difficulty swallowing or breathing
Breathing symptoms in very premature infants
  • interruption in breathing or longer gaps between breaths in premature infants
  • rapid, shallow breathing
  • shortness of breath
Muscle, blood and skin symptoms
  • loss of muscle tone or floppiness in infants
  • neck and/or joint stiffness
  • easy bruising or bleeding
  • severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
  • red or purple bruise-like spots that do not fade under pressure welling of the eyelids or face resulting from fluid retention
Other
  • a seizure or convulsion which may be accompanied by a very high temperature
  • intolerance or sensitivity of bright light (photophobia)
  • recurrence of nephrotic syndrome in children - a condition of the kidney - which results in swelling around the face or eyes and frothy urine
Call your doctor straightaway, 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 or your child 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 NeisVac-C contains

Active ingredient
(main ingredient)

Each dose of NeisVac-C contains the following active ingredients:

  • 10 micrograms of meningococcal group C polysaccharide
  • 10 to 20 micrograms of tetanus toxoid protein
Other ingredients
(inactive ingredients)
  • aluminium hydroxide
  • sodium chloride
  • water for injection
NeisVac-C does not contain preservatives.

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

What NeisVac-C looks like

NeisVac-C is supplied in a pre-filled syringe without a needle, containing one dose of 0.5 mL (AUST R 83093).

The product is supplied in a pack containing a single syringe.

NeisVac-C is a white to off-white suspension in a single dose glass syringe. All parts of the syringe are latex-free.

Who distributes NeisVac-C

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in March 2023.

® = Registered Trademark

Published by MIMS June 2023

BRAND INFORMATION

Brand name

NeisVac-C Vaccine

Active ingredient

Meningococcal group C polysaccharide conjugate vaccine

Schedule

S4

 

1 Name of Medicine

Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate).

2 Qualitative and Quantitative Composition

Active ingredient: each 0.5 mL dose contains 10 micrograms of meningococcal polysaccharide group C conjugated with 10 to 20 micrograms of tetanus toxoid protein, adsorbed to aluminium hydroxide hydrate (adjuvant).
For the full list of excipients, see Section 6.1 List of Excipients.
The manufacturer of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be a human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product.

3 Pharmaceutical Form

NeisVac-C vaccine is a sterile suspension in water for injection; thus upon storage, a white deposit and clear supernatant can be observed. After shaking, the vaccine should be a homogenous semi-opaque white to off-white suspension filled in single dose syringes. It is supplied in a 1.0 mL pre-filled syringe (without an integrated needle), containing one deliverable 0.5 mL dose. Contains no antibacterial agent. Product is for single use in one patient only.

4 Clinical Particulars

4.1 Therapeutic Indications

NeisVac-C vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

4.2 Dose and Method of Administration

General.

The vaccine should be shaken thoroughly in order to obtain a homogenous suspension. After shaking, the vaccine should be a homogeneous semi-opaque white to off white suspension. It should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. In the event of either being observed, discard the vaccine, including the needle and syringe appropriately.
Contains no antibacterial agent. Product is for single use in one patient only. Discard any residue.

Dosage.

Infants under the age of 12 months.

Two separate injections of 0.5 mL, the first dose given not earlier than 8 weeks of age and with an interval of at least two months between doses.

Children, 12 months of age and older.

A single dose of 0.5 mL.

Adults and adolescents.

A single dose of 0.5 mL.

Booster dose.

Estimates of MnCC vaccine effectiveness, from England's routine immunisation programme, have demonstrated the need for a booster dose after an infant primary series administered under the age of 12 months. A single booster dose should be given in the second year of life.
At present numbers of subject are too small to make a recommendation regarding a booster dose for toddlers who have received a single priming dose.
Effectiveness in all other groups (up to 18 years), primed with a single dose, has, in four years of surveillance, remained ≥ 90% - both within and more than one year after scheduled vaccination.
Non-conjugated meningococcal polysaccharide vaccines should not be used for booster vaccination as they may negatively influence the immunologic memory.

Method of administration.

NeisVac-C vaccine is for intramuscular use only, preferably in the anterolateral thigh region in infants and the deltoid region in older children, adolescent and adults. The vaccine must not be administered subcutaneously or intravenously.
In children 12 to 24 months of age, the injection of the vaccine may be made in the deltoid or the anterolateral thigh region.
The administration of the vaccine should be documented by the physician, and the lot number recorded.

4.3 Contraindications

As with all vaccines, NeisVac-C vaccine is contraindicated in subjects with severe acute febrile illness. This vaccine should not be administered to subjects with known hypersensitivity to any component of the vaccine, including Tetanus Toxoid (TT), or to subjects having shown signs of hypersensitivity after previous administration of NeisVac-C vaccine.

4.4 Special Warnings and Precautions for Use

As with all vaccines administered by injection, allergic reactions, including anaphylaxis, may occur after administration of NeisVac-C. Adequate medical treatment and provisions should be available for immediate use in the rare event of an anaphylactic reaction.
Avoid accidental intravascular administration which may lead to severe hypersensitivity reactions.
No data are available on subcutaneous administration of NeisVac-C vaccine; therefore, a possibility of any toxicity or reduced efficacy is unknown. NeisVac-C vaccine has been assessed only after intramuscular administration.
Inactivated vaccines and live vaccines, particularly those in the childhood schedule, can be given during the same visit but in different limbs.

Protection against meningococcal disease.

NeisVac-C vaccine confers protection specific to Neisseria meningitidis group C. Immunisation does not protect against other sero-groups or against meningitis or septicaemia caused by other organisms. The vaccine is not able to cause meningococcal C meningitidis. As with many vaccines, protection may not be conferred in 100% of patients. Therefore, clinical alertness to the possibility of co-incidental meningitidis should be maintained. In the event of clinical symptoms consistent with an invasive meningococcal infection (including petechiae and/or purpura) following vaccination, the aetiology should be thoroughly investigated.
Immunisation with this vaccine is not a substitute for routine tetanus immunisation.

Thrombocytopenia and coagulation disorders.

Because of the risk of bleeding or haematoma at the injection site, benefits and risks should be carefully weighed when considering use of the vaccine in individuals with any coagulation disorder (e.g. thrombocytopaenia) or concomitant anticoagulant therapy.

Immunodeficiency.

In individuals with impaired immune responsiveness (e.g. due to use of immunosuppressive therapy, a genetic defect or HIV infection) this vaccine may not induce protective antibody levels following vaccination. Hence, vaccination may not result in an appropriate protective antibody response in all individuals.
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 group C even if they develop antibodies following vaccination with NeisVac-C.

Intercurrent illness.

The decision to administer or delay vaccination because of a current or recent acute clinical condition (with or without fever) depends largely on the severity of symptoms and their aetiology. Although a severe or even moderate febrile illness is sufficient reason to postpone vaccinations as the condition could be aggravated by adverse reactions to the vaccine or could impair the interpretation of possible vaccine adverse reactions, minor illness, such as mild respiratory infections with or without low grade fever, are not generally contraindications.

Persistence of serum antibodies.

The duration of antibody persistence beyond 6-8 months following vaccination with NeisVac-C vaccine and the duration of protection from invasive disease caused by Neisseria meningitidis are currently unknown. The need and appropriate time for revaccination are not currently known.

Use in the elderly.

There are no data on the use of NeisVac-C in adults aged 65 years or older.

Paediatric use.

The potential risk of apnoea and the need for respiratory monitoring for 48 - 72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

It is accepted that NeisVac-C vaccine can be administered simultaneously with other routine paediatric vaccines as long as separate sites and separate syringes are used. That is, oral polio vaccine (OPV), inactivated polio vaccine (IPV), diphtheria, tetanus and the whole cell or acellular pertussis containing vaccines (e.g. DPT, Td, DT), Haemophilus influenzae tetanus toxoid conjugate vaccines (Hib-TT), and measles, mumps and rubella vaccine (MMR). NeisVac-C must not be mixed with other vaccines in the same syringe.
The observed immune responses to co-administered vaccines have been satisfactory in:
infants in studies in which NeisVac-C has been co-administered with a 7-valent or 10-valent pneumococcal conjugate vaccine;
toddlers in a study in which NeisVac-C has been co-administered with a 7-valent pneumococcal conjugate vaccine;
infants in a study in which NeisVac-C has been co-administered with a 13-valent pneumococcal conjugate vaccine.
Concomitant administration of NeisVac-C with PRP-OMP brand Haemophilus influenzae type b vaccine has not been adequately studied. However, concomitant use should only be considered if medically important.
Co-administration of NeisVac-C (2 dose infant schedule) and Infanrix Hexa vaccine (DTaP-IPV-HBV-Hib) in a 3 dose primary series in infants did not indicate any clinically relevant interference with responses to any of the antigens in the hexavalent vaccine.
Clinical studies in which NeisVac-C vaccine was given at the same time as, but at a different site from, OPV, DTP and Hib (infant schedule), MMR (one year schedule), DT (pre-school booster) and Td (school leavers) showed no increase in adverse reactions as a result of concomitant administration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The effects of NeisVac-C on fertility have also not been established (see also Use in pregnancy, below).
(Category B2)
There is no adequate data in pregnant woman thus the safety of vaccine during pregnancy has not been established. The vaccine should not be used during pregnancy unless there is a defined risk of meningococcal C disease, in which case, the risk-benefit relationship should be evaluated.
 Safety in lactation has not been established. It is not known whether NeisVac-C enters breast milk. Use this product in a nursing woman only when it is clearly needed and the potential benefit outweighs the potential risks to the baby.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions in Table 1 have been identified from clinical studies conducted with NeisVac-C in infants (≤ 12 months of age), toddlers (12 months to 17 months of age), children (3.5 years to 18 years of age), and adults.

Adverse reactions from post-marketing surveillance (for all age groups).

These frequencies are based on spontaneous reporting rates and have been calculated using number of reports and number of doses distributed.

Blood and lymphatic system disorders.

Idiopathic thrombocytopaenic purpura, lymphadenopathy.

Immune system disorders.

Anaphylaxis, hypersensitivity reactions (including bronchospasm), facial oedema and angioedema.

Metabolism and nutrition disorders.

Decreased appetite.

Psychiatric disorders.

Sleep disorder (including impaired sleeping).

Nervous system disorders.

Dizziness, convulsions including febrile convulsions, sensory abnormalities (including hypoesthesia, paraesthesia and burning sensation), hypotonic-hyporesponsive episode, syncope, meningism, hypersomnia.
There have been very rare reports on seizures following meningococcal group C conjugate vaccines administration. Individuals usually recover rapidly. Some of the reported seizures may have been syncope. The reporting rate of seizures was below the background rate of epilepsy in children. In infants seizures were usually associated with fever and were likely to be febrile convulsions.

Respiratory, thoracic and mediastinal disorders.

Dyspnoea, wheezing, nasal congestion, apnoea in very premature infants (≤ 28 weeks of gestation).

Gastrointestinal disorders.

Nausea.

Skin and subcutaneous tissue disorders.

Rash (including maculovesicular rash, vesicular rash, maculopapular rash, papular rash, rash macular, heat rash, rash erythematosus, rash generalized, rash pruritic), urticaria, petechiae, purpura, erythema, Stevens-Johnson syndrome and erythema multiforme.

Musculoskeletal, connective tissue and bone disorders.

Musculoskeletal stiffness (including neck stiffness, joint stiffness), neck pain, pain in extremity.

General disorders and administration site conditions.

Peripheral oedema, asthenia, fatigue, chills.

Class reactions.

Relapse of nephrotic syndrome has been reported in association with administration of meningococcal group C conjugate vaccines in children.

Reporting of suspected adverse reactions.

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

There is no overdose experience with NeisVac-C vaccine. Overdosing with this vaccine is highly unlikely, as it is administered as a single dose syringe by a health professional. If doses are administered closer together than recommended or more doses than required are administered, undesirable effects may occur.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Neisseria meningitidis can cause severe systemic infections, including meningitis and septicemia. Vaccination with meningococcal polysaccharides induces the production of bactericidal antibodies that are serogroup specific. There are at least 13 serogroups, of which groups B and C are the most common. Infants below 2 years of age respond poorly to vaccination with unconjugated group C polysaccharide.
Through the protein component in the active ingredient, GCMP-TT Conjugate, the immune response to the polysaccharide antigen becomes T cell dependent. By cooperation of T cells and B cells, the immune response toward the polysaccharide moiety is enhanced, particularly in younger children. Repeated administration of the polysaccharide protein conjugate provides a good booster effect via an induction of cell memory. This is shown by the level of the IgG antibody after the first injection of GCMP-TT conjugate which continues to increase after the booster injection.
The un-conjugated homologue GCMP, like other polysaccharide antigens in these groups, divalent vaccine (groups A and C) and tetravalent vaccine (groups A, C, W135, Y), are T cell independent antigens. The B cells recognise the polysaccharide without the need of T cell co-operation. However, the immune response is low, particularly in children younger than two years, who most need protection against invasive Neisseria meningitidis. Despite inducing protection in adults and older children that lasts at least 12 months, the antibody levels decline rapidly and repeated vaccination fails to induce a booster effect.

Clinical trials.

All clinical studies with NeisVac-C vaccine were conducted in the United Kingdom, as summarised in Table 2. Over five completed Phase II clinical trials the immunogenicity of NeisVac-C vaccine was evaluated in infants (n = 83, aged 2 months), toddlers (n = 76, aged 12 - 17 months), pre-school school children (n = 310, 3.5 to < 6 years of age), and school leavers (n = 319, 13 to 17 years of age). Phase III Clinical trials included children (n = 1,341, 4 - 18 years of age) and healthy infants (n = 537, 6 - 11 weeks of age). Subjects achieving a fourfold rise in serum bactericidal activity (SBA) measured with infant rabbit complement (rSBA), rSBA titres > 1:8, > 1:16 and > 1:32, group C specific IgG titres > 2 microgram/mL and a fourfold rise in group C specific IgG titres from baseline to 3 - 5 weeks post vaccination with NeisVac-C vaccine were considered as a clinical success. The profile of the serum bactericidal titres of the age groups vaccinated with NeisVac-C vaccine during phase II clinical trials is shown in the Table 2.
Instead of human complement, rabbit complement was used in the SBA assays. The results were not directly comparable to that of SBA assays where human complement was used. However, a strong correlation was routinely observed between GCMP specific IgG and SBA responses using rabbit complement for both adult and infant sera. Rabbit complement resulted in bactericidal titres averaging 4.4-fold higher than those seen using human complement. Thus, the original protective SBA threshold titre of 1:4 with human complement would therefore translate to 1:16 or 1:32 dilution when using rabbit complement. The SBA titres of > 32 were considered to indicate seroconversion.
Among infants aged 2 to 4 months vaccinated with NeisVac-C vaccine, 100% developed serum bactericidal titres of at least 1:8 one month after the second dose of this vaccine and greater than 99% had titres of at least 1:32 final dilution of the test sera. A booster dose in the second year of life induces an anamnestic response (booster effect).
The immunogenicity of NeisVac-C vaccine was compared with that of other conjugated group C meningococcal vaccines in 226 children aged 12 to 18 months in a published study conducted by the UK Public Health Laboratory Service. One month after the vaccines were given 82 - 97% of children had SBA titres > 1:32, 91 - 100% had titres > 1:8 and 89 - 100% had a > 4 fold increase in SBA titre. NeisVac-C vaccine induced higher SBA GMTs p < 0.001) and higher proportions of SBA > 1:8 (p=0.02) than did the MCC-CRM197 protein conjugates.

Protective efficacy.

There have been no protective efficacy studies conducted with NeisVac-C vaccine. Three conjugated group C meningococcal vaccines, including NeisVac-C vaccine, are in use in the UK.
Surveillance data from England (Trotter C, et al. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 2004; 364:365-67) is shown in Table 3.

5.2 Pharmacokinetic Properties

Evaluation of pharmacokinetic properties is not available for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

The mutagenic potential of the active ingredient in NeisVac-C vaccine has not been evaluated.

Carcinogenicity.

The carcinogenic potential of the active ingredient in NeisVac-C vaccine has not been evaluated.

6 Pharmaceutical Particulars

6.1 List of Excipients

Inactive ingredients: aluminium hydroxide hydrate (1.4 mg, equivalent to 0.5 mg aluminium), sodium chloride (4.1 mg) and water for injection to 0.5 mL. No preservative is added to the formulation.

6.2 Incompatibilities

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

6.3 Shelf Life

42 months stored at 2°C to 8°C (in a refrigerator). Within this shelf life NeisVac-C can be stored at 25°C (room temperature) for a single period of up to 9 months and the product must not be returned to the refrigerator. The expiry date of the vaccine is shown on the label and packaging.

6.4 Special Precautions for Storage

NeisVac-C vaccines should be stored at 2°C to 8°C (in a refrigerator). Do not freeze.
Can be stored at room temperature (≤ 25°C) for a single period up to 9 months within the shelf life. When it is stored at room temperature, the initial date must be recorded and counted for a maximum of 9 months shelf life. At the end of this period the product should be used or discarded.
Upon storage, a white deposit and clear supernatant can be observed.

6.5 Nature and Contents of Container

NeisVac-C vaccine is presented as a semi-opaque white to off-white suspension in a single dose Type 1 (EP) glass syringe with a grey, isoprene bromobutyl tip cap and grey, bromobutyl rubber plunger stopper (Type 1, EP). The stopper and tip cap are latex free.

Pack size.

1's, 10's (2 x 5 trays) and 20's (2 x 10 trays). Not all pack sizes would 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.

6.7 Physicochemical Properties

Chemical structure.

The capsular polysaccharide, referred to as GCMP (group C meningococcal polysaccharide) in NeisVac-C vaccine, is a linear polymer of repeated unit of [(2---9)-α-N-acetyl neuraminic acid; (C11H19NO9)n], with a defined molecular size. It is covalently bonded to a carrier protein, tetanus toxoid (TT).
The capsular polysaccharide is isolated from the fermentation of Neisseria meningitidis serogroup C (strain C11). The GCMP-TT Conjugate is devoid of an acetyl group at either C-7 or C-8 of the sialic acid (de-O-acetylated derivative). The oxidised GCMP intermediate is covalently bonded to TT protein by a reductive amination reaction, yielding the active ingredient, GCMP-TT conjugate.

CAS number.

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes