Status: approved as component of multivalent vaccines

Organizations involved:

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

Sanofi Pasteur S.A. – Parent co.

Walter Reed Army Institute of Research (WRAIR), U.S. Army – R&D; Tech.

Cross ref: See the entries for Meningococcal Vaccines (#497); and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined (Menomune-A/C/Y/W-135) (#502); Menomune–A/C (#499). See the entry below for Menjugate, a type C vaccine, from Chiron Corp.

Nomenclature: Meningococcal Vaccine, C/Sanofi [BIO]; Meno-mune-C [TR]; Meningococcal Polysaccharide Vaccine, Group C [FDA]; Meningococcal Polysaccharide Vaccine Group C [USAN]; Neisseria meningitidis Group C vaccine [SY]

Companies.: The vaccine is manufactured by Sanofi Pasteur Inc. (Swiftwater, PA), CBER est. no. 1277.

FDA class: Biologic PLA

CBER class: Bacterial Antigens and Vaccines

Approvals: Date = 19751019; first approval, PLA (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 group C infection [unofficial]

Status: The product is FDA-approved, but is not marketed. It is used by Sanofi Pasteur Inc. for manufacture (as a component) of two combination vaccines – Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined (Menomune-A/C/Y/W-135), and Meningococcal Polysaccharide Vaccine, Groups A and C Combined (Menomune–A/C).