A -- PHASE II TRIAL OF PNEUMOCOCCAL CONJUGATE VACCINE IN THE GAMBIA -- PRELUDE TO AN EFFICACY TRIAL The National Institute of Allergy and Infectious Diseases intends to negotiate for a 1 year contract with the Medical Research Council (MRC) of Great Britain. The nature of the work is to conduct a Phase I/II clinical trial to compare the reactogenicity and immunogenicity of combining a 9-valent pneumococcal conjugate vaccine with other vaccines, including DPT, Hib conjugate vaccine, or a meningococcal C conjugate vaccine. This contract will provide information that will subsequently support an efficacy trial of the pneumococcal conjugate vaccine in the Upper River and Central River Divisions of The Gambia. The contractor is uniquely qualified to design and conduct these studies, and this contract will permit access to a population at high risk for developing pneumonia within the first two years of life. Inherent duplication of cost to the Government and unacceptable delays in completing the project, make competition unfeasible for the conduct of this clinical trial. Authority 41 U.S.C. 253( c)(1) as set forth in FAR 6.302-1. See Numbered Note 22. POC: Sara Southard, Contract Specialist, (301) 402-6289; Carl Henn, Contracting Officer, (301) 496-0993.

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