Results of preclinical trial for trivalent seasonal influenza vaccine IVACFLU-S produced by IVAC in Vietnam, 2014 – 2017

Abstract

Preclinical trial is a step that the requirement for vaccine manufacturing process. As guidline of WHO TRS 297, 2005, vaccine preclinical trial includes safety tests, toxicity tests, and immunity tests. During 2014 – 2016, Institute of Vaccine and Medical Biologicals had been implemented the preclinical trial for 3 lots of trivalent seasonal influenza vaccine IVACFLU-S. The results showed that 3 lots of trivalent seasonal influenza vaccine IVACFLU-S met the criteria about innocuity test, specifc toxicity test, endotoxin test, and immunity test by WHO TRS No. 297, 2005 and Vietnamese Pharmacopoeia IV, 2009. Microscopic anatomy had not seen the tissue lesions of livers, lungs, kidneys, and bone marrow on experiment animals. Conclusion, three lots of trivalent seasonal influenza vaccine IVACFLU-S were granted the preclinical trial