Full name
A Phase 2a Randomized, Observer-Blind, Study to Evaluate the Immunogenicity and Safety of mRNA-Based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age And Older
NCT Number
NCT07121192
Geography
Non-US
Locations
TBD
Primary Endpoints
- Geometric Mean Titer (GMT) Ratio of Antigen 1 Titer. At Day 29
- Geometric Mean Increase (GMI) of Antigen 1 Titer. From Day 1 to Day 29
- Percentage of Participants with Antigen 1 Seroconversion Rate (SCR). From Day 1 to Day 29
- Percentage of Participants with Antigen 1 Seroprotection Rate (SPR). At Day 1 and Day 29
- Number of Participants with Solicited Administration Site Adverse Events (Aes). From Day 1 to Day 7
- Number of Participants with Solicited Systemic Aes. From Day 1 to Day 7
- Number of Participants with Unsolicited Aes. From Day 1 to Day 28
- Number of Participants with Serious Adverse Events (SAEs). From Day 1 to Day 181 (study end)
- Number of Participants with Adverse Events of Special Interest (AESIs). From Day 1 to Day 181 (study end)
- Number of Participants with Medically Attended Adverse Events (MAAEs). From Day 1 to Day 181 (study end)
- Number of Participants with any Laboratory abnormalities. From Day 1 to Day 29
Order
2
Disease
Version
Phase
2a
Status
Not yet recruiting