ACWY Vax Vaccine

A

1. Name Of The Medicinal Product

ACWY Vax - powder and solvent for solution for injection in a pre-filled syringe

Meningococcal polysaccharide groups A, C, Y and W135 vaccine

2. Qualitative And Quantitative Composition

After reconstitution, 1 dose (0.5 ml) contains:

 

Neisseria meningitidis group A polysaccharide

50 µg

Neisseria meningitidis group C polysaccharide

50 µg

Neisseria meningitidis group Y polysaccharide

50 µg

Neisseria meningitidis group W135 polysaccharide

50 µg

For a full list of excipients, see section 6.1.

  3. Pharmaceutical Form

Powder and solvent for solution for injection in a pre-filled syringe.

The powder is white. The solvent is clear and colourless.

4. Clinical Particulars 4.1 Therapeutic Indications

Active immunisation of children older than 2 years, adolescents and adults against invasive meningococcal disease caused by meningococci of groups A, C, W135 and Y.

ACWY Vax should be used in accordance with available official recommendations.

4.2 Posology And Method Of Administration

Posology

One dose of 0.5 ml.

Subjects who remain at increased risk of invasive meningococcal disease may be revaccinated at intervals (see persistence of immune response in Section 5.1). Intervals should be in accordance with available official recommendations.

Method of administration

ACWY Vax is for deep subcutaneous injection only.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Hypersensitivity after previous administration of ACWY Vax.

As with other vaccines, the administration of ACWY Vax should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contra-indication for immunisation.

4.4 Special Warnings And Precautions For Use

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of the vaccine.

Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.

ACWY Vax should under no circumstances be administered intravascularly or intradermally.

ACWY Vax will only confer protection against Neisseria meningitidis groups A, C, W135 and Y. Protection cannot be guaranteed in every individual vaccinated.

The vaccine may not elicit a protective immune response in subjects with impaired immune systems.

Group C, W135 and Y polysaccharides are poorly immunogenic in children less than 24 months of age. Group A polysaccharide induces an antibody response in children from the age of 6 months. However, the response is lower than that observed in older subjects and may be transient.

Group C polysaccharide may induce immunological hyporesponsiveness to further doses of polysaccharide C or to meningococcal group C conjugate vaccine. The clinical relevance of this phenomenon remains unknown.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no data on concomitant administration of ACWY Vax and other vaccines.

Different injection sites should be used when concomitant administration with other injectable vaccines can not be avoided.

4.6 Pregnancy And Lactation

Pregnancy

Adequate human data on use during pregnancy and adequate animal reproduction studies are not available.

Nevertheless, vaccination during pregnancy may be considered when there is an increased risk for meningococcal disease.

Lactation

Adequate data on the administration of ACWY Vax to women who are breast-feeding are not available.

However, ACWY Vax may be administered to breast-feeding women when there is an increased risk of meningococcal disease.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

In recent clinical studies, ACWY Vax was administered to 502 subjects.

The most commonly reported adverse reactions were pain at the injection site and redness at the injection site.

Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination.

Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.

Frequencies are reported as:

Very common: (

Common: (

Uncommon: (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Nervous system disorders:

Very Common: headache

Common: drowsiness

Uncommon: dizziness

Gastrointestinal disorders:

Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhoea

Skin and subcutaneous tissue disorders:

Uncommon: urticaria, rash

Metabolism and nutrition disorders:

Common: loss of appetite

General disorders and administration site conditions:

Very common: pain, redness at the injection site, fatigue

Common: fever, swelling at the injection site

Psychiatric disorders:

Common: irritability

In a WHO study conducted in Ghana, ACWY Vax was administered to 177 adults. The following adverse reactions were observed in this trial:

Very common: tenderness at injection site

Common: induration at injection site.

In addition, the following adverse reactions have been reported during post-marketing surveillance:

Skin and subcutaneous tissue disorders:

Angioneurotic oedema

Musculoskeletal and connective tissue disorders:

Arthralgia, musculoskeletal stiffness

General disorders and administration site conditions:

Influenza-like symptoms, chills

Immune system disorders:

Allergic reactions, including anaphylactic and anaphylactoid reactions

4.9 Overdose

Cases of overdose (up to 10 times the recommended dose) have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Bacterial vaccines, ATC code: J07AH04

Immunogenicity data

ACWY Vax induces bactericidal antibodies against meningococci of groups A, C, W135 and Y.

The current formulation of ACWY Vax was shown immunologically non-inferior to the previous formulation of the vaccine in a trial conducted in Lebanon in 161 subjects aged 2-30 years.

The immunogenicity of the previous formulation of ACWY Vax was evaluated in four clinical studies conducted in Belgium, Lebanon, Poland and Taiwan (N =341) in subjects aged 2-30 years.

Antibody titres were measured with the serum bactericidal assay (SBA).

Vaccine response was defined as seroconversion for initially seronegative subjects (with SBA titre below 1:8) or as four-fold increase in SBA titre from pre to post vaccination for initially seropositive subjects.

The percentage of vaccine responders observed in the four clinical studies conducted with the previous formulation were as follows:

In children aged 2-5 years: Group A - 69.1%, Group C - 93.1%, Group W135 - 89.3%, Group Y - 79.2%.

In subjects aged 6-30 years: Group A - 72.2%, Group C - 95.4%, Group W135 - 92.3%, Group Y -81.2%.

In initially seronegative subjects seroconversion rates were 100% for Group A and Y, and at least 92.9% for Group C and W135.

The risk of meningococcal disease is much higher in individuals with late complement component deficiency (LCCD) because of their inability to kill meningococci via the classical and alternative pathways. However, ACWY Vax induces anti-capsular polysaccharide antibodies against each of the four groups in LCCD subjects. In spite of the complement deficiency, killing of meningococci A, C, W135 and Y is observed when sera from LCCD subjects vaccinated with ACWY Vax are incubated with human neutrophils.

Efficacy data

In response to a meningococcal disease epidemic in Burkina Faso, a mass vaccination campaign with Mencevax ACW was performed in more than 1.68 million children and adults aged from 2 to 29 years. The vaccine effectiveness against group A and W135 disease was 95.8% (95% CI: 81.8%-99.0%) for persons with reported vaccination.

Persistence of immune response

Literature data supports the persistence of vaccine induced antibody response for at least 3 years.

An ongoing clinical study has demonstrated that 100% of subjects aged 18-25 years had bactericidal antibody titres 135 and Y and 96% for group C two years after vaccination.

In a study conducted in Ghana in 177 subjects aged 15-34 years, 100%, 88.4% and 93.5% of subjects had SBA titres 135, respectively at approximately one year after vaccination with ACWY Vax.

In studies conducted among complement-deficient subjects, the antibodies persisted for 3 years post vaccination with ACWY Vax and the revaccination restored antibody concentrations.

5.2 Pharmacokinetic Properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on general safety tests performed in animals.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Powder :

Sucrose

Trometamol

Solvent:

Sodium chloride

Water for injections

6.2 Incompatibilities

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

6.3 Shelf Life

3 years.

After reconstitution, the vaccine should be used immediately. However, chemical and physical in-use stability has been demonstrated for 8 hours at 2-8°C.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Store in the original package in order to protect from light.

6.5 Nature And Contents Of Container

Powder in a vial (type I glass) with a stopper and solvent (0.5 ml) in a pre-filled syringe (type I glass) with a stopper with or without needles– pack size of 1.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be inspected visually for any foreign particulate matter and/or other coloration prior to administration. In the event of either being observed, discard the vaccine.

ACWY Vax must be reconstituted by adding the entire content of the supplied container of solvent to the vial containing the powder. The powder should be completely dissolved in the solvent.

The reconstituted vaccine is a clear colourless solution.

7. Marketing Authorisation Holder

SmithKline Beecham plc

Trading as:

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

8. Marketing Authorisation Number(S)

PL 10592/0301

9. Date Of First Authorisation/Renewal Of The Authorisation

23/06/2008

10. Date Of Revision Of The Text

09/02/2011

POM

ACWY Vax Vaccine

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