Data Sheet
MENCEVAX ACWY
Group A, C, W135 and Y polysaccharide meningococcal vaccine
Presentation
MENCEVAX ACWY is a lyophilized preparation of purified polysaccharides from Neisseria meningitidis (meningococcus) of groups A, C, W135 and Y.
MENCEVAX ACWY is presented as a white pellet in a glass vial. The sterile diluent is clear and colourless and presented in a glass vial.
MENCEVAX ACWY meets the World Health Organisation requirements for biological substances and for meningococcal meningitis vaccines.
Each 0.5ml dose of reconstituted vaccine contains 50 μg of each of the polysaccharide of groups A, C, W135 and Y.
Clinical Particulars
Therapeutic indications
MENCEVAX ACWY is indicated for active immunisation of adults and children over two years against meningococcal meningitis caused by group A, group C, group W135 and group Y meningococci. The vaccine may also be used for:
- Subjects who are close contacts of patients with disease caused by meningococci of groups A, C, W135 and Y.
- Travellers to countries where the disease is epidemic or highly endemic.
- Controlling epidemics of infection caused by group A, C, W135, Y meningococci in confined communities.
MENCEVAX ACWY is not recommended for use in infants and children under two
years of age, as antigenicity of the vaccine is low in this age group and
antibodies persist for shorter duration.
Posology and method of administration
MENCEVAX ACWY should be reconstituted only with the saline diluent supplied by adding the entire contents of the diluent vial to the vaccine vial. The reconstituted vaccine should be inspected for any foreign particulate matter and/or colouration (other than a possible slight pink cloudiness) prior to administration. In the event of either being observed, discard the vaccine. The vaccine pellet should be completely dissolved in the diluent.
The reconstituted vaccine should be administered subcutaneously with a sterile syringe and needle. For adults and children over 2 years, one dose of vaccine is contained in 0.5ml.
The vaccine must not be administered intravenously.
MENCEVAX ACWY should under no circumstances be administered intravascularly.
Contraindications
MENCEVAX ACWY should not be administered to subjects with known hypersensitivity to any component of the vaccine or to subjects having shown signs of hypersensitivity after previous administration of MENCEVAX ACWY.
Special warnings and special precautions for use
As with other vaccines, the administration of MENCEVAX ACWY should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunisation.
MENCEVAX ACWY gives no protection against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y.
If administered to subjects with impaired immune responses, the vaccine may not induce an effective response.
The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroups A, W135 and Y. However, the seroconversion rate for the serogroup A is acceptable in children from the age of 6 months onwards.
As with all injectable vaccines, appropriate medication (eg adrenaline) should always be readily available for treatment 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.
Interactions with other medicaments and other forms of interaction
MENCEVAX ACWY can be administered at the same time as other vaccines.
The other injectable vaccines should always be administered at a different injection site.
Pregnancy and lactation
Pregnancy
Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. Mencevax ACWY should be used during pregnancy only when clearly needed and when the possible advantages outweigh the possible risks for the foetus.
Lactation
Adequate data on the administration of Mencevax ACWY to women who are breast-feeding are not available. However, as with other polysaccharide vaccines, one does not expect vaccination with Mencevax ACWY to harm the mother or the infant. Mencevax ACWY should be administered to women who are breast-feeding when needed and the possible advantages outweigh the possible risks.
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
The safety profile presented below is based on data from clinical studies. 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: ≥ 10%
Common: ≥ 1% and < 10%
Uncommon: ≥ 0.1% and < 1%
Rare: ≥ 0.01% and < 0.1%
Very rare: < 0.01%
Metabolism and nutrition disorders:
Common: appetite lost
Psychiatric disorders:
Very common: irritability
Nervous system disorders:
Very common: drowsiness, headache
Uncommon: dizziness
Very rare: somnolence
Gastrointestinal disorders:
Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhoea
Musculoskeletal and connective tissue disorders:
Common: myalgia
General disorders and administration site conditions:
Very common: erythema, slight induration, tenderness, pain and redness at the injection site, fatigue.
Common: swelling at the injection site, fever
In addition, the following adverse reactions have been reported during post-marketing surveillance:
Immune system disorders
Allergic reactions, including anaphylactic and anaphylactoid reactions
Skin and subcutaneous tissue disorders
Urticaria, rash, angioneurotic oedema
Musculoskeletal and connective tissue disorders
Arthralgia, musculoskeletal stiffness
General disorders and administration site conditions
Influenza-like symptoms, chills
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.
Pharmacological Properties
Pharmacodynamic properties
MENCEVAX ACWY induces bactericidal antibodies against meningococci of the serogroups A, C, W135 and Y.
Administration of a single 0.5ml dose of MENCEVAX ACWY elicits a significant bactericidal antibody response against meningococci of the serogroups A, C, W135 and Y in about 95% of subjects.
Polysaccharide A is known to be immunogenic in infants from the age of six months. The seroconversion rate of children vaccinated under the age of two years is lower for the serogroup C and to a lesser extent for the serogroups W135 and Y.
Pharmacokinetic properties
Evaluation of pharmacokinetic data is not required for vaccines.
Preclinical safety data
Not applicable.
Pharmaceutical Particulars
Excipients
Powder: lactose
Diluent: sodium chloride, water for injections
Special precautions for storage
The lyophilised vaccine should be stored in a refrigerator between 2oC and 8oC, or in a freezer. The diluent can be stored at ambient temperatures.
After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If not used within 8 hours, it should be discarded because of the risk of contamination. It is recommended to protect the reconstituted vaccine from direct sunlight.
When supplies of MENCEVAX ACWY are distributed from a central cold-store, it is good practice to arrange transport under refrigerated conditions, particularly in hot climates.
If the lyophilised vaccine has been accidentally exposed to high temperatures not exceeding the time and temperature limits indicated below, the expiry date no longer applies: it should preferably either be used immediately or stored at -20oC.
If it is thought that the thermal stability limits have been exceeded, the vaccine should be discarded or, if economically justified, be retested for potency before use.
Additional information on stability
The following experimental data give an indication of the stability of the vaccine and are not recommendations for storage:
MENCEVAX ACWY is stable for at least 6 months when stored at +22oC.
At a temperature of +45oC, it retains its potency for at least 3
months and for 1 week at +60oC.
The reconstituted vaccine is stable for 1 month when kept at +4oC
and for at least 1 week at +25oC and about 4 days when kept at +37oC.
Shelf life
The expiry date of the vaccine is indicated on the label and packaging. When stored under prescribed conditions of temperatures between 2°C and 8°C the shelf-life is 2 years.
Medicine Classification
Prescription Medicine.
Package Quantities
Monodose vials. A container of sterile saline diluent is supplied for reconstitution of the lyophilized vaccine.
Name and Address
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Street
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
ph (09) 367 2900
fax (09) 367 2506
Date of Preparation
13 October 2006