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 in healthy adults 18 to 85 years of age.
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 7
Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]
Timeframe: From Day 22 to Day 28
Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 7
Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]
Timeframe: From Day 22 to Day 28
Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 21
Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]
Timeframe: From Day 22 to Day 42
Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 203
Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 203
Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A]
Timeframe: From Day 1 to Day 203
Phase 1: Percentage of participants with increase in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8
Timeframe: Baseline (Day 1), Day 8
Phase 1: Percentage of participants with increase in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29
Timeframe: Baseline (Day 1), Day 29
Phase 1: Percentage of participants with increase in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8
Timeframe: Baseline (Day 1), Day 8
Phase 1: Percentage of participants with increase in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29
Timeframe: Baseline (Day 1), Day 29
Percentage of participants with anti- hemagglutinin inhibition (HI) titers ≥ 1:40 at Day 43 [Phase 1 and Phase 2 Part A]
Timeframe: At Day 43
Percentage of participants with solicited administration site events [Phase 2 Part B]
Timeframe: From Day 1 to Day 7
Percentage of participants with solicited administration site events [Phase 2 Part B]
Timeframe: From Day 22 to Day 28
Percentage of participants with solicited systemic events [Phase 2 Part B]
Timeframe: From Day 1 to Day 7
Percentage of participants with solicited systemic events [Phase 2 Part B]
Timeframe: From Day 22 to Day 28
Percentage of participants with unsolicited AEs [Phase 2 Part B]
Timeframe: From Day 1 to Day 21
Percentage of participants with unsolicited AEs [Phase 2 Part B]
Timeframe: From Day 22 to Day 42
Percentage of participants with MAAEs [Phase 2 Part B]
Timeframe: From Day 1 to Day 203
Percentage of participants with SAEs [Phase 2 Part B]
Timeframe: From Day 1 to Day 203
Percentage of participants with AESIs [Phase 2 Part B]
Timeframe: From Day 1 to Day 203
Percentage of participants with increase in FDA toxicity grading for clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B]
Timeframe: Baseline (Day 1), Day 8
Percentage of participants with increase in FDA toxicity grading for clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 [Phase 2 Part B]
Timeframe: Baseline (Day 1), Day 29
Percentage of participants with increase in clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B]
Timeframe: Baseline (Day 1), Day 8
Percentagev of participants with increase in clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 [Phase 2 Part B]
Timeframe: Baseline (Day 1), Day 29
Percentage of participants with anti-HI titers ≥ 1:40 at Day 43 [Phase 2 Part B]
Timeframe: At Day 43
Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]
Timeframe: At Day 43 compared to pre-vaccination (Day 1, pre-dosing)
GMT Ratio of anti-HI antibody titers [Phase 2 Part B]
Timeframe: At Day 43