Full name

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

NCT Number
NCT06382311
Geography
US
Locations

United States

Primary Endpoints
  • Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]. From Day 1 to Day 7
  • Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A]. From Day 22 to Day 28
  • Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]. From Day 1 to Day 7
  • Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A]. From Day 22 to Day 28
  • Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]. From Day 1 to Day 21
  • Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A]. From Day 22 to Day 42
  • Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A]. From Day 1 to Day 203
  • Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A]. From Day 1 to Day 203
  • Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A]. 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. 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. 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. 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. 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]. At Day 43
  • Percentage of participants with solicited administration site events [Phase 2 Part B]. From Day 1 to Day 7
  • Percentage of participants with solicited administration site events [Phase 2 Part B]. From Day 22 to Day 28
  • Percentage of participants with solicited systemic events [Phase 2 Part B]. From Day 1 to Day 7
  • Percentage of participants with solicited systemic events [Phase 2 Part B]. From Day 22 to Day 28
  • Percentage of participants with unsolicited AEs [Phase 2 Part B]. From Day 1 to Day 21
  • Percentage of participants with unsolicited AEs [Phase 2 Part B]. From Day 22 to Day 42
  • Percentage of participants with MAAEs [Phase 2 Part B]. From Day 1 to Day 203
  • Percentage of participants with SAEs [Phase 2 Part B]. From Day 1 to Day 203
  • Percentage of participants with AESIs [Phase 2 Part B]. 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]. 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]. 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]. 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]. Baseline (Day 1), Day 29
  • Percentage of participants with anti-HI titers ≥ 1:40 at Day 43 [Phase 2 Part B]. At Day 43
  • Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B]. At Day 43 compared to pre-vaccination (Day 1, pre-dosing)
  • GMT Ratio of anti-HI antibody titers [Phase 2 Part B]. At Day 43
Order
0
Disease
Pandemic Flu
Menu title
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
Version
AAFP/FMX 2025
Phase
1/2
Status
Recruiting