Status: FDA approved; gov’t/controlled distribution

Organizations involved:

Sanofi Pasteur Inc. – Manuf.; R&D; Tech.

Sanofi Pasteur S.A. – Intl. mark.; Parent

U.S. Department of Defense (DOD) - USA mark.

Cross ref: See the entries for Meningococcal Vaccines (#497), and the Group A and C component vaccines. See the entry for Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined (#502).

Nomenclature: Meningococcal Vaccine, A/C [BIO]; Meno-mune–A/C [TR]; Meningococcal Polysaccharide Vaccine, Groups A and C Combined [FDA]; Neisseria menin-gitidis Groups A and C vaccine [SY]

Companies.: The vaccine is manufactured by Sanofi Pasteur Inc. (Swiftwater, PA), FDA CBER est. no. 1277. It is marketed in the U.S. by Sanofi Pasteur Inc., although the primary (or only) customer is the Department of Defense (DOD); and perhaps internationally by Sanofi Pasteur S.A. affiliates.

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19751019; first approval, PLA no. 75-737, granted to Merrell-National Labs., Richardson-Merrell Inc.

Date = 19780103; approval revoked and granted (reissued) to new owner, Connaught Labs., Inc. (CLI)

Date = 19991209; approval revoked from CLI and granted (reissued) to new owner, Aventis Pasteur Inc.

Indications: for prevention of disease due to Neisseria menin-gitidis groups A and C infection [unofficial]

Status: The product is approved, but is not actively marketed. The vaccine is and has been purchased by the Department of Defense (DOD) to vaccinate persons in the U.S. military.