Safety Testing of Dengue-1 and Dengue-3 Seeds for Human Challenges, Unattenuated; Hepatitis A Virus, Strain HM175
Abstract
Hepatitis A Virus, Strain HM175, Vaccine F I-2, Lot 1A of 16 Oct 87 and Lot 1B of 4 Dec 87 was satisfactorily safety-tested in accordance with the guidelines established by the FDA for live and inactivated vaccines as stipulated in 21 CFR, Parts 610.11, 610.12, 630.10-630.17, etc. All testing procedures were carried out following Good Laboratory Practices (GLP) regulations (21 CFR, Part 58). Results are reported herein. Keywords: Vaccines; Laboratory test; Dengue-1; Dengue-3; Hepatitis A; Viral seeds.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 1988
- Accession Number
- ADA201722
Entities
People
- Louis Potash