SOLICITATION NOTICE
R -- Italian DTaP Trial Cohorts Study
- Notice Date
- 6/12/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2002-N-00448
- Response Due
- 8/1/2002
- Archive Date
- 8/16/2002
- Point of Contact
- Charlotte Flitcraft, Contract Specialist, Phone (770)488-2632, Fax (770)488-2847, - Rebecca O'Kelley, Supervisory Contract Specialist, Phone (770)488-2636, Fax (770)488-2670,
- E-Mail Address
-
cflitcraft@cdc.gov, ROKelley@CDC.GOV
- Description
- The Centers for Disease Control and Prevention (CDC) intends to negotiate on a sole source basis with the Alberto Tozzi, Laboratorio di Epidemiologia e Biostatistica Instituto Superoire di Sanita, located in Viale Regina Elena, Rome; a contract to compare prevalence rates of neurodevelopmental disorders among DtaP vaccine trial particiapants exposed to varying quantities of thimersol (an organic mecury compound used as a preservative)during infancy in randomized, controlled trials of acellular pertussis vaccines. These services will include, but is not limited to the following two Phases (1) Develop and conduct a pilot study. Task 1, Determine the success rate of tracing children who belonged to the original cohort involved in the Italian trial of acellular pertussis vaccines. Task 2, Assess the participation rate for a follow-up study among the candidate families identified in Task 1. Task 3, Confirm the assumed prevalence figures for ADHD and speech or language delay disorders among Italain children (as used in the sample sized estimates presented above) in children who are identified for participation in the follow-up study. Task 4, Conduct objective neuropsychological testing in Italian children participating in the pilot study. This testing would begin with tracing and recruitment of 200 children (100 per vaccine group) to whom the tests would be administered. A neuropsychological test battery similar to one being used by CDC in their follow-up study of HMO cohorts exposed to different levels of thimersol will be utilized in this study as well. Italian specialists in neuropsychological testing will identify appropriate Italian tests if a specific test from the CDC battery is not available in Italian (or cannot be successfully translated into Italian for technical reasons). Phase (2), Develop and conduct a follow-up study among an entire regional cohort of children who participated in the acellular pertussis vaccine trial. Task 1, Identify and specifically train nurses who will be responsible for tracing and recruiting children into the follow-up study. Additionally, it is suggested that the 20 nurses who worked on the original acellular pertussis vaccine trial in the Veneto region and who followed these children for cough illnesses in the Region be contacted and recruited as study nurses for this follow-up study. Task 2, The second phase of the study will require the recruitment of an entire regional cohort of children who participated in the vaccine trial in order to minimize selection bias. This phase of the study will seek to enroll a total of 1200 children (600 from each of the two vaccine arms)to meet the sample size estimates provided above. Task 3, Train a sufficient number of pediatric neurologists or neuropsychological technicians to standardized the administration of neuropsychological tests to 1200 children. Task 4, Administer neuropsychological tests to children participating in the follow-up study at local vaccination or pediatrics clinics. Task 5, Tabulate results of neuropsychological tests performed in a written report. It is estimated that the second phase of this study would require an additional 18 months to complete. The Alberto Tozzi Laboratorio di Epidemilogia e Biostatistica Istituto Superiore di Sanita, is the only known institution in Viale Regina Elena Roma that can provide the necessary infrastructure to perform this project. The period of performance is twenty-four months. It is anticipated that the contract will be awarded around September 27, 2002 with performance to begin September 29, 2002. The scheduled solicitation issue date is approximately July 1, 2002. The solicitation will also be posted at this website (http://www.eps.gov/) on or around July 1, 2002. Any amendments issued to this solicitation will also be available at the same website. Hardcopies of the solicitation and any amendments issued will not be mailed to the offerors. The North American Industry Classification (NAICS) code for this solicitation is 561110. Notes 1 and 26*****
- Record
- SN00092165-W 20020614/020613084037 (fbodaily.com)
- Source
-
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