A -- Phase III Efficacy Trial of Pneumococcal Conjugate Vaccine in The Gambia

The National Institute of Allergy and Infectious Diseases intends to negotiate for a 3-year contract with the Medical Research Council (MRC) of Great Britain. The nature of the work is to complete a Phase III trial to evaluate the efficacy of a 9-valent pneumococcal conjugate vaccine in a pediatric population in the Upper River and Central River regions of The Gambia, West Africa. This contract will provide information and support for the completion of the trial, which was implemented in July, 2000 in collaboration with the NIAID/NIH, USAID, WHO, the Gates Foundation, and the MRC. The contractor is uniquely qualified to complete the trial, which has enrolled approximately 8,000 patients. This contract will permit continued 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 and completion of this clinical trial. Authority 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1.