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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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