Preparation and Research on Meningococcal Vaccines
Abstract:
A contract was arranged between the U.S. Department of Defense and Merck Co., Inc. to prepare on a feasability basis 20 gms. of meningococcal polysaccharide vaccine, type C and on a best-effort basis up to 20 gms. of meningococcal polysaccharide vaccine, type A. The methodology for general vaccine preparation and control testing was established by the U.S. Army and was supplied to Merck Co., Inc. in the form of specifications. The duration of the contract was from October 6, 1970 to December 31, 1971. The contractual committment was met on schedule. Slightly more than 20 gms. of meningococcal polysaccharide vaccine, type C was produced 413,350 x 50 mcg doses. The material was produced as eight separate lots, each of which met the specifications of the contract. They were delivered as lyophilized formulations. Release protocols describing the preparation and control testing procedures and results for each of the lots accompanied the vaccines. A summary of the lot numbers and quantities delivered is included.