Influenza, Human Clinical Trial
Official title:
A Phase 1/2, Randomized, Observer-blind, Dose-finding/Dose-confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the mRNA-based Investigational Pandemic H5 Influenza Vaccine Candidate Administered in Healthy Younger and Older Adults
The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age.
Phase 1 (Ph1) of the study aims to evaluate the reactogenicity, safety, and immunogenicity of 5 dose levels of the investigational vaccine, compared with a placebo, in both younger adults (YA) and older adults (OA). Participants will receive two doses, 21 days apart, with safety data collected up to Day 29. The data from this phase will support the safety evaluation of the assessed dose levels and enable further assessment in higher number of participants in Phase 2 Part A. Phase 2 (Ph2) Part A will assess the immunogenicity, reactogenicity, and safety of the same 5 dose levels evaluated in Phase 1, with the aim of identifying the doses to proceed to Phase 2 Part B. Phase 2 Part B will evaluate the reactogenicity, safety, and immunogenicity of either up to 2 dose levels selected from Phase 2 Part A (Scenario 1), or up to 2 higher dose levels (Scenario 2) in a one dose schedule manner. ;
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