Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study

摘要: INTRODUCTION AND AIM A trivalent live attenuated influenza vaccine (Nasovac-S®) was developed and licensed in India. phase 4 study conducted to assess safety. METHODOLOGY This non-randomized, open-label, single-arm among individuals ≥ 2 years of age involved administration 0.5 mL Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries. RESULTS Among 500 vaccinated subjects, 160 between 2 17 years age, 240 18-49 years old 100 50 years older. total 533 solicited reactions reported. The majority these mild, almost all them resolved without any sequelae. 20% subjects reported at least one local reaction, 23% systemic reaction. None the 45 unsolicited AEs by 37 (7.4%) causally related vaccine. CONCLUSIONS data from adds existing safety database Nasovac-S. REGISTRY Clinical Trials Registry India (CTRI/2015/08/006074).