SOURCES SOUGHT
A -- Phase 3 Clinical Trials
- Notice Date
- 11/23/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- RDECOM Contracting Center - Natick R&D (RDECOM-CC), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- DVC0000-00183-10
- Response Due
- 12/22/2010
- Archive Date
- 2/20/2011
- Point of Contact
- Lawrence Mize, 301-619-9813
- E-Mail Address
-
RDECOM Contracting Center - Natick R&D (RDECOM-CC)
(lawrence.mize@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Description: - Please provide your capabilities statement for the following work: A Phase 3, double-blinded, randomized, study of the Recombinant Plague Vaccine rF1V in healthy volunteers will be conducted to demonstrate 1) safety and immunogenicity of the optimized dosage and schedule of the rF1V vaccine in an expanded target population in order to meet the FDA requirements for vaccine licensure, and 2) vaccine lot comparability for three independent lots according to FDA guidelines. Lot-to-lot comparability will be based on immunogenicity data from a subset of the total volunteer safety population (450 volunteers per lot). We are assuming approximately 4, 590 volunteers required; Thirty-three hundred volunteers will be actively treated with rF1V vaccine (1,100 per lot x 3 lots) and 1,650 volunteers will be vaccinated with saline (control). We estimate to meet the planned objectives, including enrollment timelines, the number of investigation sites needs to be between 40 to 100 sites (including 10 military sites). Also an option for one international location. Please provide your capabilities statement and past performance for same/similar work via email to Jo Ann Brown, Principal Subcontract Administrator, DynPort Vaccine Company, a CSC Company (DVC), at jbrown253@csc.com.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/b310c6efaeb5fb575cd9cee2c19c0902)
- Place of Performance
- Address: Dynport Vaccine Company 64 Thomas Johnson Drive Frederick MD
- Zip Code: 21702-4300
- Zip Code: 21702-4300
- Record
- SN02332521-W 20101125/101123234204-b310c6efaeb5fb575cd9cee2c19c0902 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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