Full name
A Phase 1/2, Randomized, Partially-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
- 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
- Phase 1: Percentage of participants with increase in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at 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
- 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
- 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
Version
Phase
1/2
Status
Recruiting