Meningococcal Polysaccharide Vaccine

MENINGOCOCCAL POLYSACCHARIDE VACCINE, GROUPS A, C, Y AND W-135 COMBINED, MENOMUNE®

Connaught

Vaccine

Action And Clinical Pharmacology: Meningitis can be caused by a variety of microorganisms including several sero-groups of meningococci. This vaccine will not stimulate protection against infections caused by organisms other than Groups A, C, Y and W-135 meningococci. It has been demonstrated that the presence of human serum bactericidal antibodies to meningococcal antigens is strongly correlated with immunity to meningococcal disease. Studies have shown that meningococcal polysaccharides induce the formation of such antibodies in man. Subsequently large scale field studies in South Africa showed group A polysaccharide vaccine to be 100% effective in preventing systemic disease caused by group A organisms occurring 2 weeks or longer after immunization. In addition large scale field studies in the U.S. Army showed group C polysaccharide vaccine to be at least 87% effective in preventing systemic disease caused by group C organisms. A study performed using 5 lots of Meningococcal Polysaccharide Vaccine, Groups A and C Combined in 4 343 adults showed at least a 4 fold increase of bactericidal antibodies to both group A and C in 95% of subjects. A study performed using 4 lots of Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined in 150 adults showed at least a 4 fold increase in bactericidal antibodies to all groups in greater than 90% of the subjects.

A study was conducted in 73 children 2 to 12 years of age. Post-immunization sera were not obtained on 4 children. Therefore, the seroconversion rates were based on 69 paired samples. Seroconversion rates as measured by bactericidal antibody were: Group A-72%, Group C-58%, Group Y-90% and Group W-135-82%. Seroconversion rates as measured by a 2-fold rise in antibody titres based on Solid Phase Radioimmunoassay were: Group A-99%, Group C-99%, Group Y-97% and Group W-135-89%.

In recent years, the reported incidence of meningococcal disease in Canada has ranged between 200 and 300 cases (20% infants). Mortality has varied from 5 to 15% and about one quarter of the deaths are infants.

As with any vaccine, vaccination with Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined may not protect 100% of susceptible individuals. Protective antibody levels may be achieved within 10 to 14 days after vaccination.

Indications And Clinical Uses: Primarily in persons 2 years of age and older at risk in epidemic or highly endemic areas. Vaccination should also be considered for household or institutional contacts of meningococcal disease as an adjunct to appropriate antibiotic chemoprophylaxis. Medical and laboratory personnel at risk of exposure to meningococcal disease should also be considered for vaccination. Vaccine may be of benefit for some travelers planning to visit countries recognized as having epidemic meningococcal disease. The quadrivalent vaccine also should be used to prevent meningococcal disease in populations clearly demonstrated to be at increased risk, such as military recruits.

Vaccine should be administered to adults and children 2 years of age or older with functional or anatomic asplenia. Whenever possible, vaccine should be given at least 10 to 14 days before splenectomy.

Contra-Indications: Immunization should be deferred during the course of any acute illness.

It is a contraindication to administer the vaccine to individuals known to be sensitive to thimerosal or any other component of the vaccine.

Manufacturers’ Warnings In Clinical States: If the vaccine is used in persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Precautions: As with any injection of biological materials, epinephrine HCl (1:1 000) should be immediately available as a precautionary measure should an acute anaphylactoid reaction occur.

Prior to an injection of any vaccine, all known precautions should be taken to prevent side reactions. This includes a review of the patient’s history with respect to possible sensitivity to the vaccine or similar vaccines.

Special care should be taken to avoid injecting the vaccine intradermally or i.v. since clinical studies have not been done to establish safety and efficacy of the vaccine using these routes of administration.

A separate sterile syringe and needle should be used for each individual patient to prevent transmission of hepatitis B virus or other infectious agents from person to person.

Pregnancy: Safety in pregnant women has not been established. It is prudent not to use them unless there is a substantial risk of infection.

Animal reproduction studies have not been conducted with Meningococcal Polysaccharide Vaccine Groups A, C, Y and W-135. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be given to a pregnant woman unless in the opinion of the attending physician vaccination is clearly required.

Children: There are no data on safety and efficacy of this vaccine when administered to children under 2 years of age.

Adverse Reactions: The incidence and kinds of reactions reported in adults and children in clinical studies are presented in Table I. As with the administration of any biological, one should expect possible hypersensitivity reactions.

Epinephrine HCl Solution (1:1 000) always must be immediately available to combat unexpected anaphylactic or other allergic reactions.

Health-care providers should report any occurrences temporally related to the administration of the product in accordance with provincial and federal statutory requirements.

Dosage And Administration: Inspect visually for extraneous particulate matter and/or discoloration prior to administration. Reconstitute the vaccine using only the diluent supplied for this purpose. Draw the volume of diluent shown on the diluent label into a suitable size syringe and inject into the vial containing the vaccine. Shake vial until the vaccine is dissolved. Administer the vaccine s.c.

The immunizing dose is a single injection of 0.5 mL s.c. The vaccine can be given at the same time as other immunizations if needed.

There are no data on the incidence and degree of reactions following booster doses of quadrivalent meningococcal vaccine.

Each person who is immunized should be given a permanent personal immunization record. In addition, it is essential that the health care provider also maintain a permanent record of the immunization history of each individual. This office record should contain the name of the vaccine, date given, dose, manufacturer and lot number.

Jet Injector Use: Inspect visually for extraneous particulate matter and/or discoloration prior to administration.

Using a syringe and needle of suitable size and aseptic precautions, transfer the volume of diluent shown on the diluent label into the vial containing the vaccine. Shake vial until the vaccine is dissolved.

Administer only with automatic hypodermic jet apparatus. 50 dose vial not to be utilized in needle and syringe method of immunization. If absolutely necessary, syringes and needles may be used with such containers with caution; however, the full 50 doses may not be obtained. Discard partially used vial of vaccine.

Immunization consists of a single injection of 0.5 mL given s.c. Special care should be taken by using the deltoid area to avoid injecting the vaccine intradermally or i.v. since clinical studies have not been done to establish safety and efficacy of the vaccine using these routes of administration.

Any unused reconstituted vaccine remaining in a vial which has been administered with a Jet Injector Apparatus should be discarded and not retained for later use.

Note: During use it is possible that the nozzle of the Jet Injector Apparatus may become contaminated with blood or serum. If this occurs, the nozzle should be cleansed and sterilized before continued use to prevent the possibility of transmission of hepatitis B virus and other infectious agents.

Availability And Storage: The vaccine is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y and Group W-135 for s.c. injection. The diluent is sterile pyrogen-free distilled water to which thimerosal (mercury derivative) 1:10 000 is added as a preservative. After reconstitution with diluent as indicated on the label, each 0.5 mL dose contains 50 µg of “isolated product “from each Group A, C, Y and W-135 in isotonic sodium chloride solution preserved with thimerosal (mercury derivative). Each dose of vaccine also contains 2.5 mg to 5 mg of lactose added as a stabilizer. The vaccine when reconstituted is a clear colorless liquid.

1 Dose Vial of vaccine, with vial of 0.6 mL diluent.

10 Dose Vial of vaccine, with vial of 6 mL diluent, for administration with needle and syringe (may be used with jet injector although the desired number of doses may not be obtained).

50 Dose Vial of vaccine, with vial of 27.5 mL diluent, for jet injector use only.

Store freeze-dried vaccine and reconstituted vaccine, when not in use, between 2 to 8°C. Discard remainder of 10 dose vials of vaccine within 5 days after reconstitution. The single dose vial should be used within 24 hours of reconstitution. Any unused reconstituted vaccine remaining in a 50 dose vial should be discarded and not retained for later use.

MENINGOCOCCAL POLYSACCHARIDE VACCINE, GROUPS A, C, Y AND W-135 COMBINED, MENOMUNE® Connaught Vaccine

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