Influenza, Human Clinical Trial
Official title:
Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying mRNA Influenza Vaccine in Healthy Adults
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo. The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 1 | |
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Phase 2 | |
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Phase 3 | |
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Phase 3 | |
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N/A | |
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Phase 3 | |
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Phase 2 | |
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N/A | |
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Phase 3 |