A -- TO STUDY THE IMMUNOGENICITY AND DOSING RANGE OF A NEW LOT OF VI-REPA IN A COMPARABLE SITE AND POPULATION (TWO-FIVE YEAR-OLDS)

Notice Date

August 24, 2001

Contracting Office

National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

ZIP Code

20892-7510

Solicitation Number

HD-01-012

Point of Contact

Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD (301) 435-6958

E-Mail Address

Contact the NICHD Contracting Officer (mh89m@nih.gov)

Description

The National Institute of Child Health and Human Development (NICHD), National Institutes of Health is planning to award a contract to Huu Nghi Hospital, Dong Thap Province, Vietnam, using other than full and open competition to study the immunogenicity and dosing range of a new lot of Vi-rEPA in a comparable site and population (Two-five year-olds). The study will take one year. The proposed study is part of the on-going Phase 3 study and was requested by the FDA to compare the immunogenicity of the new lot of Vi-rEPA to compare the levels of IgG anti-Vi with those obtained in the Phase 3 trial from the same 2-5 year-olds group. The determination to use other than full and open competition was made in accordance with 41 USC 253 (1), and is based upon the following: 1) Dong Thap province has been performing the Phase 3 study and they have an easy accessibility to the same population. 2) the proposed contractor are well qualified and capable of performing the study efficiently. The purpose of this synopsis is to determine whether there are other sources with the prerequisite qualifications to perform the proposed study. An organization capable of performing the task should submit a statement of capabilities with documentation supporting its ability within 45 days of this to: Mrs. Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, 6100 Executive Boulevard, Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510 (See Note Numbered 22)

Web Link

NICHD Contracts Office (www.nih.gov)

Record

Loren Data Corp. 20010828/ASOL004.HTM (W-236 SN50V8X1)