Mencevax® ACWY (Meningococcal polysaccharide serogroup ACWY vaccine) (Mencevax® ACWY)

Mencevax® ACWY (Meningococcal polysaccharide serogroup ACWY vaccine) (Mencevax® ACWY)

Immunogenicity

The Mencevax® ACWY vaccine induces the production of bactericidal antibodies against meningococcal serogroups A, C, W135 and Y. Immunogenicity was assessed by quantitative determination of serum bactericidal antibodies using a rabbit complement-based test system (rSBA).

The immunological correlate of protective effectiveness against meningococcal serogroups A, C, W135 and Y is the percentage of individuals with a bactericidal antibody titer ≥ 1:8.

The immunogenicity of the Mencevax® ACWY vaccine after 1 dose was assessed in clinical studies (2,200 vaccinated people over 2 years of age). Serum bactericidal antibodies were quantified by GlaxoSmithKline using the rabbit complement assay (rSBA).

Immune response was defined as a bactericidal antibody (rSBA) titer ≥32 in initially seronegative individuals (pre-vaccination rSBA titer < and as at least a four-fold increase in post-vaccination rSBA titer compared with pre-vaccination rSBA titers in initially seropositive individuals (pre-vaccination rSBA titer ≥ 8).

Immunogenicity in children aged 2 to 10 years

In children aged 2 to 10 years, the production of serum bactericidal antibodies to the antigens included in the Mencevax® ACWY vaccine, 1 month after administration of 1 dose of the vaccine, was: to the meningococcal antigen Neisseria meningitidis serogroup A - 64.6%, serogroup C- 89.7%, serogroup W135 - 82.6% and serogroup Y - 68.8%.

Immunogenicity in adolescents (11-17 years) and adults (18-55 years)

In adolescents aged 11-17 years, the production of serum bactericidal antibodies to the antigens included in the Mencevax® ACWY vaccine, 1 month after administration of 1 dose of the vaccine, was: to the meningococcal antigen Neisseria meningitidis serogroup A -77.5%, serogroup C -96 .7%, serogroup W135 - 87.5% and serogroup Y - 78.5%.

In adults aged 18-55 years, the production of serum bactericidal antibodies to the antigens included in the Mencevax ACWY vaccine, 1 month after administration of 1 dose of the vaccine, was: to the meningococcal antigen Neisseria meningitidis serogroup A - 69.8%, serogroup C - 92, 0%, serogroup W135 - 85.5% and serogroup Y - 78.8%.

Immunogenicity in the elderly (≥ 56 years)

At the age of 56 and older, the production of serum bactericidal antibodies to the antigens included in the Mencevax® ACWY vaccine, 1 month after administration of 1 dose of the vaccine, was: to the meningococcal antigen Neisseria meningitidis serogroup A - 73.3%, serogroup C - 74.2% ,

Immunogenicity in high-risk groups

Data from studies conducted in individuals with late complement deficiency (31 participants) and bone marrow transplant recipients (44 participants) demonstrated that Mencevax® ACWY vaccination provided an adequate immune response. In patients with deficiency of late components of the complement system, the geometric mean titer of antibodies to the meningococcal antigen Neisseria meningitidis

serogroup A was 26.8 µg/ml, serogroup C was 19.2 µg/ml, serogroup W135 was 16.4 µg/ml and serogroup Y was 30.7 µg/ml 13 weeks after vaccination. Among patients who underwent bone marrow transplantation, 62-84% of individuals had polysaccharide A antibody concentrations ≥ 2.0 μg/ml, and 76-84% of individuals had polysaccharide C antibody concentrations ≥ 2.0 μg/ml at one month after vaccination.

Efficiency

The effectiveness of Mencevax® ACWY was demonstrated in more than 1.68 million children and adults aged 2 to 29 years during a mass vaccination campaign against the Neisseria meningitidis

in Burkina Faso.
During the mass vaccination campaign, 32 cases of meningitis due to Neisseria meningitidis
serogroup A and 3 cases of meningitis due to
Neisseria meningitidis
serogroup A were reported. W135.

Mencevax ACWY - meningococcal vaccine

Mencevax ACWY (Belgium)

*this vaccine is temporarily out of stock

Currently, this vaccine is not available in the clinic. A conjugate vaccine is available for the prevention of meningococcal infection of serogroups A, C, Y, W – MENACTRA

The Mencevax ACWY vaccine is a lyophilized preparation of purified polysaccharides of Neisseria meningitidis (meningococcus) serogroups A, C, W135 and Y.

The Mencevax ACWY vaccine meets WHO requirements for biological products and meningococcal vaccines.

Dosage form: lyophilisate for the preparation of a solution for subcutaneous administration complete with solvent

Compound

0.5 ml (1 dose) of the dissolved vaccine contains 50 μg of each polysaccharide of serogroups A, C, W135 and Y.

Excipients:

• Vaccine: lactose
• Solvent: 0.9% sterile sodium chloride solution contains 0.25% phenol as a preservative

Immunobiological properties

The Mencevax ACWY vaccine causes the production of bactericidal antibodies against meningococci of serogroups A, C, W135 and Y.

Administration of one dose of 0.5 ml of Mencevax ACWY vaccine causes the production of a significant amount of bactericidal antibodies against meningococcal serogroups A, C, W135 and Y in approximately 95% of immunized individuals.

It is known that polysaccharide A is immunogenic for children older than 6 months. The rate of seroconversion in children vaccinated before the age of 2 years is reduced for the polysaccharide antigen of serogroup C and, to a lesser extent, for the polysaccharide antigens of serogroups W135 and Y.

Indications

The Mencevax ACWY vaccine is indicated for active immunization of adults and children aged 2 years against meningococcal meningitis caused by meningococci of serogroups A, C, W135 and Y.

This vaccine is especially recommended for people who are at high risk of infection, such as those who live in or travel to areas where the infection is endemic or highly endemic.

It is also recommended for persons living in closed communities or in contact with patients with meningitis caused by meningococci of serogroups A, C, W135 and Y.

Contraindications

Mencevax ACWY vaccine should not be administered to people with a known hypersensitivity to any of its components, or to people who have shown signs of hypersensitivity after previous administrations of this vaccine.

Scheme of application and dose

One immunizing dose is 0.5 ml of dissolved vaccine.

Method of administration

The Mencevax ACWY vaccine is intended for subcutaneous administration only.

Under no circumstances should Mencevax ACWY be administered intravenously.

Before use, the vaccine should be dissolved with the supplied solvent at the rate of 0.5 ml per dose. Shake the bottle thoroughly until the contents are completely dissolved. The dissolved drug is a clear, colorless solution. If it looks different, or if there are foreign particles, the vaccine is not used. A new sterile needle must be used to administer the drug. When using a vaccine in a multi-dose package, a new syringe and needle must be used to withdraw the drug each time. The drug must be removed from the vial under strict aseptic technique in order to prevent contamination.

Side effects

Mencevax ACWY may cause erythema, mild induration, tenderness, or pain at the injection site.

It is extremely rare for vaccinated individuals to experience headache, general malaise, fever, allergic reactions, including anaphylactoid reactions, and drowsiness.

Interaction with other drugs

The Mencevax ACWY vaccine can be administered simultaneously with other vaccines, and the drugs must be injected with different syringes into different parts of the body.

The Mencevax ACWY vaccine cannot be mixed with other vaccines.

special instructions

As with other vaccines, administration of Mencevax ACWY should be delayed in persons with acute severe febrile illness. However, mild infection is not a contraindication for immunization.

Mencevax ACWY vaccine does not protect against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y.

When administered to immunocompromised individuals, this vaccine may not produce an effective immune response.

Vaccination provides for the fact that the rate of seroconversion in children vaccinated before the age of 2 years is reduced for the polysaccharide antigen of serogroup C and, to a lesser extent, for the polysaccharide antigens of serogroups A, W135 and Y. It should be noted, however, that the rate of seroconversion in relation to the polysaccharide antigen of serogroup A is quite satisfactory in children aged 6 months and older.

As with all injectable vaccines, you should always have supplies available to treat anaphylactic reactions that may occur after receiving Mencevax ACWY. Vaccinated persons must be under medical supervision for 30 minutes after administration of the vaccine.

Pregnancy and lactation

Currently, there is no data on the use of this vaccine in pregnant women, as well as data on its effect on the reproductive system of laboratory animals. Based on theoretical premises, pregnant women should avoid administering the Mencevax ACWY vaccine, unless such women are at high risk of infection.

Storage conditions

The vaccine is stored and transported at a temperature of 2 to 8°C. The solvent is stored and transported at temperatures from 2° to 25°C; freezing is not allowed.

After diluting the lyophilisate with a solvent, the vaccine should be used immediately. The solution can be stored in the refrigerator for no more than 8 hours. The solution should be protected from direct sunlight.

Shelf life - 2 years

Mencevax

Vaccination schedule : Once for children over 2 years of age and adults.
Revaccination after 2 years. The Mencevax ACWY vaccine is a lyophilized preparation of purified polysaccharides of Neisseria meningitidis (meningococcus) serogroups A, C, W135 and Y. The Mencevax ACWY vaccine meets the WHO requirements for biological products and meningococcal vaccines.

Dosage form Lyophilisate for the preparation of a solution for subcutaneous administration, complete with a solvent.

Composition 0.5 ml (1 dose) of the dissolved vaccine contains 50 μg of each polysaccharide of serogroups A, C, W135 and Y.

Excipients: Vaccine: lactose. Solvent: 0.9% sterile sodium chloride solution contains 0.25% phenol as a preservative

Immunobiological properties The Mencevax ACWY vaccine causes the production of bactericidal antibodies against meningococci of serogroups A, C, W135 and Y.

Administration of one dose of 0.5 ml of the Mencevax ACWY vaccine causes the production of a significant amount of bactericidal antibodies against meningococcal serogroups A, C, W135 and Y in approximately 95% of immunized individuals. Polysaccharide A is known to be immunogenic in children over 6 months of age. The rate of seroconversion in children vaccinated before the age of 2 years is reduced for the polysaccharide antigen of serogroup C and, to a lesser extent, for the polysaccharide antigens of serogroups W135 and Y.

Indications Mencevax ACWY vaccine is indicated for the active immunization of adults and children aged 2 years against meningococcal meningitis caused by meningococcal serogroups A, C, W135 and Y. This vaccine is especially recommended for people who are at high risk of infection, such as those living in areas where the infection is endemic or highly endemic, or visits such areas. It is also recommended for persons living in closed communities or in contact with patients with meningitis caused by meningococci of serogroups A, C, W135 and Y.

Contraindications The Mencevax ACWY vaccine should not be administered to people with known hypersensitivity to any of its components, as well as to people who have shown signs of hypersensitivity after previous administrations of this vaccine.

Dosage and administration regimen One immunizing dose - 0.5 ml of dissolved vaccine.

Method of administration The Mencevax ACWY vaccine is intended for subcutaneous administration only. Under no circumstances should the Mencevax ACWY vaccine be administered intravenously.

Before use, the vaccine should be dissolved with the supplied solvent at the rate of 0.5 ml per dose. Shake the bottle thoroughly until the contents are completely dissolved. The dissolved drug is a clear, colorless solution. If it looks different, or if there are foreign particles, the vaccine is not used. A new sterile needle must be used to administer the drug. When using a vaccine in a multi-dose package, a new syringe and needle must be used to withdraw the drug each time. The drug must be removed from the vial under strict aseptic technique in order to prevent contamination.

Side effects Mencevax ACWY vaccine may cause erythema, mild induration, tenderness or pain at the injection site. It is extremely rare for vaccinated individuals to experience headache, general malaise, fever, allergic reactions, including anaphylactoid reactions, and drowsiness.

Interaction with other drugs The Mencevax ACWY vaccine can be administered simultaneously with other vaccines, and the drugs must be injected with different syringes into different parts of the body. The Mencevax ACWY vaccine cannot be mixed with other vaccines.

Special instructions As with the use of other vaccines, the administration of the Mencevax ACWY vaccine should be postponed in persons with acute severe febrile illness. However, mild infection is not a contraindication for immunization. Mencevax ACWY vaccine does not protect against meningococcal meningitis caused by meningococci belonging to serogroups other than A, C, W135 and Y. When administered to immunocompromised individuals, this vaccine may not produce an effective immune response. The seroconversion rate in children vaccinated before 2 years of age is reduced for serogroup C polysaccharide antigen and, to a lesser extent, for serogroup A, W135 and Y polysaccharide antigens. It should be noted, however, that the seroconversion rate for serogroup A polysaccharide antigen quite satisfactory in children aged 6 months and older. As with all injectable vaccines, you should always have supplies available to treat anaphylactic reactions that may occur after receiving the Mencevax ACWY vaccine. Vaccinated persons must be under medical supervision for 30 minutes after administration of the vaccine.

Pregnancy and lactation Currently, there is no data on the use of this vaccine in pregnant women, as well as data on its effect on the reproductive system of laboratory animals. Based on theoretical premises, one should refrain from administering the Mencevax ACWY vaccine to pregnant women, unless such women are at high risk of infection.

Release form

• 1 dose of vaccine in a vial along with 0.5 ml of solvent in an ampoule and instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in an ampoule in a plastic blister. 1 blister along with instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in a vial and instructions for use in a cardboard box.
• 1 dose of vaccine in a vial along with 0.5 ml of solvent in a glass syringe with 1 or 2 needles is packaged in a plastic blister. 1 blister along with instructions for use in a cardboard box.
• 1 dose of vaccine per vial. 100 bottles each along with instructions for use in a cardboard box.
• 0.5 ml of solvent per ampoule. 100 ampoules in a cardboard box.
• 10 doses of vaccine in a dark glass bottle. 50 bottles each along with instructions for use in a cardboard box.
• 5 ml of solvent in a bottle. 50 bottles in a cardboard box.

Storage conditions The vaccine is stored and transported at a temperature of 2° to 8°C. The solvent is stored and transported at temperatures from 2° to 25°C. Freezing is not allowed. After diluting the lyophilisate with a solvent, the vaccine should be used immediately. The solution can be stored in the refrigerator for no more than 8 hours. The solution should be protected from direct sunlight. Shelf life: 2 years.