Menomune^™ A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, for subcutaneous use, is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y and Group W-135. N meningitidis are cultivated with Mueller Hinton agar¹ and Watson Scherp² media. The purified polysaccharide is extracted from the Neisseria meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction and diafiltration.No preservative is added during manufacture.

The 0.78 mL vial of diluent contains sterile, preservative-free, pyrogen-free distilled water and is used for reconstitution of product supplied in 1 mL vials.The 6 mL vial of diluent contains sterile, pyrogen-free distilled water to which thimerosal (mercury derivative) 1:10, 000 is added as a preservative. The 6 mL vial is for reconstitution of product supplied in 10 mL vials. After reconstitution with diluent as indicated on the label, the 0.5 mL dose is formulated to contain 50 mg of "isolated product" from each of Groups A, C, Y and W-135 in an isotonic sodium chloride solution.

Each dose of vaccine is also formulated to contain 2.5 mg to 5 mg of lactose added as a stabilizer.³ The vaccine when reconstituted is a clear colorless liquid.

Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO)⁴ for Meningococcal Polysaccharide Vaccine.

THIS VACCINE CONFORMS TO THE WORLD HEALTH ORGANIZATION (WHO) REQUIREMENTS.

REFERENCES

1. Mueller H, et al. A protein-free medium for primary isolation of the gonococcus and meningococcus. Proc Soc Exp Biol Med 48: 330, 1941

2. Watson RG, et al. The specific hapten of group C (group II a) meningococcus. II. Chemical nature. J Immunol.81: 337, 1958

3. Tiesjema RH, et al. Enhanced stability of meningococcal polysaccharide vaccines by using lactose as a menstruum for lyophilization. Bull WHO 55:43-48, 1977

4. WHO Technical Report Series, No. 658, 1981

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