This study is a Phase 1, 2-part, randomised, double-blind, controlled, clinical trial to evaluate the safety and immune response of CodaVax-H1N1 in healthy adults aged 18 to 49 years. Participants will be enrolled in autumn 2022 (southern hemisphere) and followed through the 2022 influenza season (Part A) or enrolled in autumn 2023 and followed through the 2023 influenza season (Part B). Participants will be screened within 28 days of randomization, and eligible participants in Part A will be enrolled into 1 of 3 sequential cohorts and randomised to receive a single dose of CodaVax-H1N1, placebo (normal saline), or licenced injectable seasonal influenza vaccine (Flucelvax Quad). Each subsequent cohort will include a higher dose of CodaVax H1N1 than the previous cohort, in addition to placebo and the licensed injectable seasonal influenza vaccine. In Part B, 24 eligible participants will be enrolled into 1 of 2 sequential cohorts and randomised to receive a single IM dose of CodaVax-H1N1 or placebo.
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Safety and Tolerability by Assessing Percentage of Participants with Reactogenicity Events
Timeframe: Reactogenicity events from Day 1 to Day 7
Safety and Tolerability by Assessing Percentage of Participants with Adverse Events
Timeframe: Adverse events (AEs) from Day 1 to Day 29
Safety and Tolerability by Assessing Percentage of Participants with MAAEs, NCIs, and SAEs.
Timeframe: MAAEs, NCIs, SAEs from Day 1 to Day 181