Accession Number : ADA189486

Title :   Safety Testing of Dengue-1 and Dengue-3 Seeds for Human Challenges, Unattenuated.

Descriptive Note : Phase rept.,

Corporate Author : FLOW LABS INC MCLEAN VA

Personal Author(s) : Potash, Louis

PDF Url : ADA189486

Report Date : 26 Oct 1987

Pagination or Media Count : 39

Abstract : Japanese Encephalitis (JE), Strain SA14-14-2 - Production Seed Virus Lot No.PDK8-WR2, Mfg. Date Dec 86 and Live Attenuated Virus Vaccine Lot No. PDK9-WR3, Mfg. Date Feb 87 were satisfactorily safety-tested in accordance with guidelines established by the FDA for live and inactivated vaccines as stipulated in 21 CFR, Parts 610.11, 610.12, 630.10 - 630.18, etc. All testing procedures were carried out following Good Laboratory Practices regulations (21 CFR, Part 58). Keywords: Dengue.

Descriptors :   *DENGUE, *VACCINES, *VIRUSES, *LABORATORY TESTS, INACTIVATION, JAPANESE ENCEPHALITIS, LABORATORY PROCEDURES, LIVE VACCINES, REGULATIONS, TEST AND EVALUATION, TABLES(DATA), LABORATORY ANIMALS, JAPANESE ENCEPHALITIS VIRUSES, SAFETY

Subject Categories : Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE