drugset
drugset / Trial / NCT03497845

Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59

NCT03497845 ↗

Phase 2 Completed 720 enrolled Biomedical Advanced Research and Development Authority
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains. The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.

Timeline

Start
2018-03-15
Primary completion
2019-11-19
Completion
2019-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject AS03 Other / unclassified 0.5 ml Intramuscular
Subject IN Unknown 0.5 ml Intramuscular
Subject MF59 adjuvant Other / unclassified 0.5 ml Intramuscular
Subject VN Unknown 0.5 ml Intramuscular
Subject bhg/QL Unknown 0.5 ml Intramuscular
Subject dk/BANG Unknown 0.5 ml Intramuscular
Subject gf/WA Unknown 0.5 ml Intramuscular

Indications

avian influenza