At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Surface Antigen, Inactivated, Egg-Derived, Trivalent Influenza (Agrippal®) Virus Vaccine, Southern Hemisphere Formulation 2015, in Healthy Adults.
In Brief
A Phase 2 clinical trial evaluating Aggripal® for Human Influenza. Completed, enrolled 126 participants across 1 site.
Detailed Summary
The present study is designed to evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years. For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination. The vaccine composition will be based on the WHO recommended influenza strains for the 2015 Southern Hemisphere vaccine, and the data from this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same.
Study Details
Timeline
Interventions
TIV