At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-Blinded, Phase 2 Study to Assess Safety and Immunogenicity of Homologous and Heterologous Prime-Boost Vaccination Strategies With Stockpiled Inactivated Monovalent Influenza A(H5) Vaccines Administered Intramuscularly With Either AS03 or MF59® as Adjuvant
In Brief
A Phase 2 clinical trial evaluating VN, IN, and 5 other interventions for Influenza A Virus, H5N1 Subtype. Completed, enrolled 720 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose