The main aim of this proposal is to evaluate the potential of one or more acellular pertussis vaccines to protect against typical or severe disease as compared to whole cell vaccine and/perhaps placebo, and to estimate the relative protection against infection per se. This solicitation is a request for a feasibility statement and a developmental plan which, in six months time, would allow the contractor(s) to submit a detailed proposal fo a clinical trial to demonstrate the safety and efficacy of acellular pertussis vaccines. Part 1 addresses the basic, but essential criteria and qualifications needed to properly conduct a Phase III efficacy trial to compare one or more acellular pertussis vaccines to a whole cell product including: 1. Development of a protocol for a clinical trial to determine the safety and efficacy of acellular pertussis vaccines that satisfies the requirement outlined in Part 2. 2. Development of a protocol for data collection and data base management as part of the Part 2 effort. 3. Provide for laboratory analyses of the clinical specimens obtained in th conduct of the trial. 4. Describe methods of recruitment, follow-up and maintaining subject population.
